TriangleNCT02859415 · STUDY IN CONTEXT
Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Ne
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
MTD is defined as the number of participants experiencing a dose-limiting toxicity (DLT). A DLT is defined as Grade 4 or greater anemia or neutropenia exceeding 5 days duration, thrombocytopenia requiring transfusion, or Grade 3 or greater nonhematologic toxicity possibly, probably, or definitely related to the investigational therapy excluding alopecia during Cycle 1 of therapy.
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1. Plasma and blood will also be collected.
Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1.
Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1.
Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1.
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-lung-neoplasm
- nct id
- NCT02859415
- trial label
- Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Ne
- 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
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0000
- source section id
- NCT02859415-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose (MTD)
- endpoint definition
- MTD is defined as the number of participants experiencing a dose-limiting toxicity (DLT). A DLT is defined as Grade 4 or greater anemia or neutropenia exceeding 5 days duration, thrombocytopenia requiring transfusion, or Grade 3 or greater nonhematologic toxicity possibly, probably, or definitely related to the investigational therapy excluding alopecia during Cycle 1 of therapy.
- time origin
- At the end of first 14 day cycle at each dose level
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0001
- source section id
- NCT02859415-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants Whose Best Response is a Complete Response (CR) or Partial Response (PR)
- endpoint definition
- Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- time origin
- every 8 weeks until at disease progression, approximately 3.5 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant in the first group only received one dose, thus was not evaluable.
- 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-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0002
- source section id
- NCT02859415-om-0002
- source outcome index
- 2
- endpoint
- To Ascertain if Mithramycin Inhibits Stem Cell Gene Expression in Participants With Thoracic Malignancies
- endpoint definition
- Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1. Plasma and blood will also be collected.
- time origin
- baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No data was collected thus this outcome measure was not done.
- 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-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0003
- source section id
- NCT02859415-om-0003
- source outcome index
- 3
- endpoint
- To Evaluate Gene Expression, Deoxyribonucleic Acid (DNA) Methylation and Micro-ribonucleic Acid (RNA) Profiles in Pre- and Post-treatment Tumor Biopsies
- endpoint definition
- Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1.
- time origin
- baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No data was collected thus this outcome measure was not done.
- 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-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0004
- source section id
- NCT02859415-om-0004
- source outcome index
- 4
- endpoint
- To Compare Gene Expression, Deoxyribonucleic Acid (DNA) Methylation and Micro-ribonucleic Acid (RNA) Profiles in Participant Tumor Biopsies With Treatment Response Profiles in Pre-clinical Studies
- endpoint definition
- Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1.
- time origin
- baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No data was collected thus this outcome measure was not done.
- 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-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0005
- source section id
- NCT02859415-om-0005
- source outcome index
- 5
- endpoint
- To Examine if Mithramycin Decreases Pluripotent Cancer Stem Cells (Side Population)
- endpoint definition
- Studies on tumor tissue obtained during baseline /previous biopsy (if available), Cycle 1 Day 4(+/- 3 days), and possible treatment evaluation following Course 1.
- time origin
- baseline, Cycle 1 Day 4 (+/- 3 days), and possible treatment evaluation following Course 1
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No data was collected thus this outcome measure was not done.
- 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-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Participants
- regimen
- All participants in phase I dose level 1 and dose level -1.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase I Dose Level 1 Mithramycin 60 mcg/kg
- regimen
- Phase I Dose Level 1 Mithramycin 60 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses..
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg
- regimen
- Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Phase I Dose Level 1 Mithramycin 60 mcg/kg
- regimen
- Phase I Dose Level 1 Mithramycin 60 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses..
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg
- regimen
- Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Phase I Dose Level 1 Mithramycin 60 mcg/kg
- regimen
- Phase I Dose Level 1 Mithramycin 60 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses..
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg
- regimen
- Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Phase I Dose Level 1 Mithramycin 60 mcg/kg
- regimen
- Phase I Dose Level 1 Mithramycin 60 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses..
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg
- regimen
- Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Phase I Dose Level 1 Mithramycin 60 mcg/kg
- regimen
- Phase I Dose Level 1 Mithramycin 60 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses..
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg
- regimen
- Phase I Dose Level -1 Mithramycin 60 mcg/kg followed by Mithramycin 30 mcg/kg Mithramycin: Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02859415-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-neoplasm
- nct id
- NCT02859415
- harm key
- EG000
- source section id
- NCT02859415-ae
- event group key
- EG000
- event group label
- Phase I Dose Level 1 Mithramycin 60 mcg/kg
- 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 1 month and 4 days, and 3 months and 17 days for the first and second group respectively.
- event definition
- Source null
- 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-lung-neoplasm
- nct id
- NCT02859415
- harm key
- EG001
- source section id
- NCT02859415-ae
- event group key
- EG001
- event group label
- Phase I Dose Level -1 Mithramycin 60 mcg/kg Followed by Mithramycin 30 mcg/kg
- serious affected
- 2
- 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 1 month and 4 days, and 3 months and 17 days for the first and second group respectively.
- event definition
- Source null
- 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