TriangleNCT02451943 · STUDY IN CONTEXT
A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression.
ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) + partial response (PR). CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1.
DCR was defined as the percentage of randomized participants achieving a best overall response of CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. PD is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales \[physical, role, cognitive, emotional, and social\]), and 9 symptom subscales \[fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea\]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- qol key
- qol-0005
- source section id
- NCT02451943-om-0005
- source outcome index
- 5
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores
- measure definition
- Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales \[physical, role, cognitive, emotional, and social\]), and 9 symptom subscales \[fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea\]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale.
- time frame
- Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EQ-5D · Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- qol key
- qol-0006
- source section id
- NCT02451943-om-0006
- source outcome index
- 6
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
- measure definition
- The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health status was calculated from a set of item weights to derive a score of 0 to 1, with 1 representing the best health status. United Kingdom (UK) weights were applied. The analysis includes all cycles for which at least 25% of participants in each arm have an assessment. For each participant a change from baseline was calculated for every post-baseline assessment by subtracting the baseline assessment result from the current assessment result. Maximum improvement (over baseline) was determined from the set of all post-baseline change scores.
- time frame
- Randomization through Follow-up (Up to 35.8 Months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized participants who had a baseline and a post-baseline measurement.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Brief Pain Inventory · Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- qol key
- qol-0007
- source section id
- NCT02451943-om-0007
- source outcome index
- 7
- instrument
- Brief Pain Inventory
- instrument basis
- matched 'brief pain inventory' in the study's own wording
- scale title
- Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
- measure definition
- Time to first worsening of the brief pain inventory short form modified (mBPI-sf) "worst pain score" was defined as the time from the date of the first study drug dose (baseline date) to the first date of a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline. The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes).
- time frame
- Randomization through Follow-up (Up to 34.5 Months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- trial label
- A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 3
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0000
- source section id
- NCT02451943-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
- time origin
- Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants. Censored participants in Doxorubicin + Olaratumab arm = 87 and Doxorubicin + Placebo arm = 91
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0001
- source section id
- NCT02451943-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS) Leiomyosarcoma (LMS)
- endpoint definition
- Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.
- time origin
- Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants with LMS. Censored participants in Doxorubicin + Olaratumab arm = 42 and Doxorubicin + Placebo arm = 40.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0002
- source section id
- NCT02451943-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression.
- time origin
- Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants. Censored participants in the Doxorubicin + Olaratumab arm = 39 and the Doxorubicin + Placebo arm =34.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0003
- source section id
- NCT02451943-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
- endpoint definition
- ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) + partial response (PR). CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1.
- time origin
- Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0004
- source section id
- NCT02451943-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)
- endpoint definition
- DCR was defined as the percentage of randomized participants achieving a best overall response of CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. PD is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- time origin
- Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.5 Months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0005
- source section id
- NCT02451943-om-0005
- source outcome index
- 5
- endpoint
- Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores
- endpoint definition
- Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales \[physical, role, cognitive, emotional, and social\]), and 9 symptom subscales \[fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea\]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale.
- time origin
- Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Doxorubicin + Olaratumab
- regimen
- 75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
- analyzed count
- 258
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Doxorubicin + Placebo
- regimen
- 75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
- analyzed count
- 251
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Doxorubicin + Olaratumab
- regimen
- 75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
- analyzed count
- 119
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Doxorubicin + Placebo
- regimen
- 75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
- analyzed count
- 115
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Doxorubicin + Olaratumab
- regimen
- 75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
- analyzed count
- 258
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Doxorubicin + Placebo
- regimen
- 75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
- analyzed count
- 251
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Doxorubicin + Olaratumab
- regimen
- 75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
- analyzed count
- 258
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Doxorubicin + Placebo
- regimen
- 75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
- analyzed count
- 251
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Doxorubicin + Olaratumab
- regimen
- 75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
- analyzed count
- 258
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Doxorubicin + Placebo
- regimen
- 75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
- analyzed count
- 251
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Doxorubicin + Olaratumab
- regimen
- 75 milligrams per meter squared (mg/m\^2) doxorubicin administered intravenously (IV) on day 1 of each 21 day cycle for 8 cycles plus 20 milligrams per kilogram (mg/kg) dose of olaratumab administered IV on day 1 and day 8 of cycle 1 and 15 mg/kg olaratumab administered IV on day 1 and day 8 of cycles 2-8. Beginning with cycle 9, 15 mg/kg olaratumab administered IV on day 1 and day 8 of each subsequent 21 day cycle until documented progressive disease (PD) or discontinuation for any other reason.
- analyzed count
- 258
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Doxorubicin + Placebo
- regimen
- 75 mg/m\^2 doxorubicin administered IV on day 1 of each 21 day cycle for 8 cycles plus placebo (equivalent volume) administered IV on day 1 and day 8 for 8 cycles. Beginning with cycle 9, placebo (equivalent volume) administered on days 1 and 8 of each subsequent 21 day cycle until PD or discontinuation for any other reason.
- analyzed count
- 251
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02451943-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- harm key
- EG000
- source section id
- NCT02451943-ae
- event group key
- EG000
- event group label
- Doxorubicin + Olaratumab
- serious affected
- 105
- serious at risk
- 257
- other affected
- 248
- other at risk
- 257
- frequency threshold
- 5
- collection period
- Baseline Up To 41 Months
- event definition
- All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatments the participants received.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- harm key
- EG001
- source section id
- NCT02451943-ae
- event group key
- EG001
- event group label
- Doxorubicin + Placebo
- serious affected
- 89
- serious at risk
- 249
- other affected
- 244
- other at risk
- 249
- frequency threshold
- 5
- collection period
- Baseline Up To 41 Months
- event definition
- All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants at risk adjusted accordingly. Based on the planned safety analysis, adverse event analysis was planned as per the treatments the participants received.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- qol key
- qol-0005
- source section id
- NCT02451943-om-0005
- source outcome index
- 5
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores
- measure definition
- Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales \[physical, role, cognitive, emotional, and social\]), and 9 symptom subscales \[fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea\]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where "worsening" was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale.
- time frame
- Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- qol key
- qol-0006
- source section id
- NCT02451943-om-0006
- source outcome index
- 6
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
- measure definition
- The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health status was calculated from a set of item weights to derive a score of 0 to 1, with 1 representing the best health status. United Kingdom (UK) weights were applied. The analysis includes all cycles for which at least 25% of participants in each arm have an assessment. For each participant a change from baseline was calculated for every post-baseline assessment by subtracting the baseline assessment result from the current assessment result. Maximum improvement (over baseline) was determined from the set of all post-baseline change scores.
- time frame
- Randomization through Follow-up (Up to 35.8 Months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized participants who had a baseline and a post-baseline measurement.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-soft-tissue-sarcoma-metastatic-30f77ca0
- nct id
- NCT02451943
- qol key
- qol-0007
- source section id
- NCT02451943-om-0007
- source outcome index
- 7
- instrument
- Brief Pain Inventory
- instrument basis
- matched 'brief pain inventory' in the study's own wording
- scale title
- Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
- measure definition
- Time to first worsening of the brief pain inventory short form modified (mBPI-sf) "worst pain score" was defined as the time from the date of the first study drug dose (baseline date) to the first date of a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline. The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes).
- time frame
- Randomization through Follow-up (Up to 34.5 Months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice