TriangleNCT01624090 · STUDY IN CONTEXT
Mithramycin for Lung, Esophagus, and Other Chest Cancers
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
Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
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
- NCT01624090
- trial label
- Mithramycin for Lung, Esophagus, and Other Chest Cancers
- 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
- 2
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01624090
- outcome key
- om-0000
- source section id
- NCT01624090-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With an Objective Response (Complete Response + Partial Response)
- endpoint definition
- Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD) is 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
- Every 8 weeks until disease progression or unacceptable toxicity, over an average of 4 months.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant in DL1 30 mcg thoracic died on study, one participant in DL1 30 mcg extra thoracic experienced a dose limiting toxicity and was taken off therapy, and 1 withdrew prior to trmt, two participants in DL1 25 mcg thoracic died on study, and two did not complete one course of therapy prior to treatment evaluation for this outcome measure.
- 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
- NCT01624090
- outcome key
- om-0001
- source section id
- NCT01624090-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Serious and Non-Serious Adverse Events
- endpoint definition
- Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- time origin
- Date treatment consent signed to date off study, approx. 9 mos & 6 days DL1 30 mcg/kg thoracic group, 2 mos & 16 days DL1 30 mcg/kg extra-thoracic group, 5 mos & 26 days DL-1 25 mcg/kg thoracic group, & 20 days DL-1 25 mcg/kg extra-thoracic group
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
- 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
- NCT01624090
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Level 1 - 30 mcg/kg Thoracic Malignancy
- regimen
- Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01624090-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01624090
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy
- regimen
- Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01624090-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01624090
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Dose Level -1 - 25 mcg/kg Thoracic Malignancy
- regimen
- Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01624090-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01624090
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy
- regimen
- Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01624090-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01624090
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose Level 1 - 30 mcg/kg Thoracic Malignancy
- regimen
- Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01624090-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01624090
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy
- regimen
- Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01624090-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01624090
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Dose Level -1 - 25 mcg/kg Thoracic Malignancy
- regimen
- Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01624090-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01624090
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy
- regimen
- Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01624090-om-0001#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-esophageal-cancer
- nct id
- NCT01624090
- harm key
- EG000
- source section id
- NCT01624090-ae
- event group key
- EG000
- event group label
- Dose Level 1 - 30 mcg/kg Thoracic Malignancy
- serious affected
- 1
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group.
- event definition
- One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
- 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-esophageal-cancer
- nct id
- NCT01624090
- harm key
- EG001
- source section id
- NCT01624090-ae
- event group key
- EG001
- event group label
- Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group.
- event definition
- One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
- 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-esophageal-cancer
- nct id
- NCT01624090
- harm key
- EG002
- source section id
- NCT01624090-ae
- event group key
- EG002
- event group label
- Dose Level -1 - 25 mcg/kg Thoracic Malignancy
- serious affected
- 2
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group.
- event definition
- One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
- 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-esophageal-cancer
- nct id
- NCT01624090
- harm key
- EG003
- source section id
- NCT01624090-ae
- event group key
- EG003
- event group label
- Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy
- serious affected
- 0
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group.
- event definition
- One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
- 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