TriangleNCT01059643 · STUDY IN CONTEXT
A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.
The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done).
The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100.
Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle).
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01059643
- trial label
- A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0000
- source section id
- NCT01059643-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
- endpoint definition
- The percentage of participants who achieved a best response of either CR or PR, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. Percentage is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
- time origin
- Baseline until progressive disease up to 36 weeks post-baseline
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled participants who received at least 1 dose of study drug.
- 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-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0001
- source section id
- NCT01059643-om-0001
- source outcome index
- 1
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- PFS defined as the time from date of first dose to the first observation of disease progression or death due to any cause. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 millimeter (mm) increase over nadir. For participants who were not known to have died or to have progressed as of the data inclusion cutoff date, PFS were censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.
- time origin
- Date of enrollment to progressive disease or death due to any cause up to 36 weeks post-enrollment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled participants who received at least 1 dose of study drug. Percentage (%) of participants censored were colorectal cancer 5.9%; gastroesophageal cancer 0.0%, non-small cell lung cancer 3.4%, ovarian cancer 15.4%, prostate cancer 16.7%, and squamous cell carcinoma of the head and neck 15.4%.
- 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-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0002
- source section id
- NCT01059643-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
- endpoint definition
- Response using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions. PR was defined as at least a 30% decrease in sum of longest diameter of target lesions and for prostate cancer PR was defined as a ≥50% decrease in baseline prostate-specific antigen (PSA) value that was confirmed with a second value ≥3 weeks later. Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir. SD was defined as small changes that did not meet above criteria.
- time origin
- Baseline until progressive disease up to 36 weeks post-baseline
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled participants who received at least 1 dose of study drug.
- 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-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0003
- source section id
- NCT01059643-om-0003
- source outcome index
- 3
- endpoint
- Tumor Marker Values as Relevant to Specific Tumor Types at Baseline
- endpoint definition
- The number of participants with colorectal cancer (CRC), gastroesophageal cancer (GE), non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer or squamous cell carcinoma of head and neck (SCCHN) who had marker/molecular diagnostics performed prior to study entry to determine the mutation status of cancer genes: APC, BRAF, BRCA1, BRCA2, HRAS and KRAS and the presence of Human Papillovirus (HPV) and Epstein Barr viruses (EBV). Mutation/virus status was defined as: positive (mutation/virus present), negative (mutation/virus not present), unknown (mutation/virus status unknown), or not done (mutation/virus status was not done).
- time origin
- Baseline
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled participants who received at least 1 dose of study drug.
- 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-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0004
- source section id
- NCT01059643-om-0004
- source outcome index
- 4
- endpoint
- Change in Tumor Size at Smallest Size (Best Response)
- endpoint definition
- The percent change in tumor size at its smallest size. The sum of diameters of target lesions was determined at each tumor assessment. The percent change is the smallest post-baseline sum divided by the baseline (pre-treatment) sum, multiplied by 100.
- time origin
- Baseline until cycle with maximum change from baseline up to 36 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled participants who received at least 1 dose of study drug with results at baseline and at time of best response.
- 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-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0005
- source section id
- NCT01059643-om-0005
- source outcome index
- 5
- endpoint
- Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 and Metabolite LSN2546307
- endpoint definition
- Plasma Cmax following daily doses of LY2523355 on Days 1, 2, and 3 of Cycle 1 (21-day cycle).
- time origin
- Day 3 of Cycle 1 (21-day cycle)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All enrolled participants who received at least 1 dose of study drug with Cmax measure.
- 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-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0000
- arm key
- OG000
- arm label
- LY2523355
- regimen
- LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
- analyzed count
- 103
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059643-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0001
- arm key
- OG000
- arm label
- LY2523355
- regimen
- LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
- analyzed count
- 103
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059643-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0002
- arm key
- OG000
- arm label
- LY2523355
- regimen
- LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
- analyzed count
- 103
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059643-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0003
- arm key
- OG000
- arm label
- LY2523355
- regimen
- LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
- analyzed count
- 103
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059643-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0004
- arm key
- OG000
- arm label
- LY2523355
- regimen
- LY2523355: Dose determined by participant body surface area: 5 milligrams/square meter(mg/m²) or 6 mg/m², administered intravenously as a one hour infusion on Days 1, 2 and 3 of a 21 day cycle for up to 2 cycles (4 cycles for prostate cancer participants). Additional cycles administered based on participant response assessment. Pegfilgrastim: 6 milligrams (mg), administered subcutaneously approximately 24 hours after third dose of LY2523355 on Day 4 of each 21-day cycle, for up to 2 cycles of LY2523355 administration (4 cycles for prostate cancer participants). Additional cycles of LY2523355 administered based on participant response assessment.
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059643-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0005
- arm key
- OG000
- arm label
- 5 mg/m² LY2523355
- regimen
- LY2523355: 5 milligrams/square meter/day (mg/m²/day) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
- analyzed count
- 65
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059643-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01059643
- outcome key
- om-0005
- arm key
- OG001
- arm label
- 6 mg/m² LY253355
- regimen
- LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01059643-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01059643
- harm key
- EG000
- source section id
- NCT01059643-ae
- event group key
- EG000
- event group label
- LY2523355
- serious affected
- 39
- serious at risk
- 103
- other affected
- 102
- other at risk
- 103
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Deaths due to (d/t) PD not considered AEs and reported in Participant Flow for those who died during study treatment. Deaths d/t unknown cause in the 30-day post-study treatment follow-up (PSTF) reported in Other Pre-Specified Outcome Measure. One death (unknown cause) in PSTF recorded by investigator as an SAE included in SAE summary as "Death".
- 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
- setting source links
Preserved source evidence · Not medical advice