TriangleNCT02535312 · STUDY IN CONTEXT
Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractor
Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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
Dose-limiting toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Pre-specified DLT criteria included the following adverse events (AE), judged to be at least possibly related to study therapy: grade 3 or greater non-hematologic toxicity, grade 3 thrombocytopenia with bleeding, any grade 4 thrombocytopenia, grade 4 febrile neutropenia lasting \> 7 day, any grade febrile neutropenia, any grade 5 toxicity. Treatment delay of cycle 2 by more than 2 weeks and inability to administer 3 of the 4 doses due to toxicity in the first treatment course were also considered DLTs. Controllable nausea, vomiting and diarrhea, electrolyte toxicities correctable (to baseline or grade 1) with repletion and grade 3 creatinine elevation correctable (to grade 1 or less) with IV hydration were not considered DLT's.
The maximum tolerated dose of TRC102 in combination with 500mg/m\^2 IV of Pemetrex and 60 or 75 mg/m\^2 IV of Cisplatin is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR
Progression-free survival will be summarized as time from first protocol treatment until progression or death from any cause, using the product-limit Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as at least a 20% increase in the sum of diameters of target lesions, 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 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Overall survival will be summarized as time from first protocol treatment until death from any cause, using the product-limit Kaplan-Meier estimator.
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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- trial label
- Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractor
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent 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
- 5
- harms Count
- 5
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0000
- source section id
- NCT02535312-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With at Least One Dose Limiting Toxicity (DLT) - Phase I
- endpoint definition
- Dose-limiting toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Pre-specified DLT criteria included the following adverse events (AE), judged to be at least possibly related to study therapy: grade 3 or greater non-hematologic toxicity, grade 3 thrombocytopenia with bleeding, any grade 4 thrombocytopenia, grade 4 febrile neutropenia lasting \> 7 day, any grade febrile neutropenia, any grade 5 toxicity. Treatment delay of cycle 2 by more than 2 weeks and inability to administer 3 of the 4 doses due to toxicity in the first treatment course were also considered DLTs. Controllable nausea, vomiting and diarrhea, electrolyte toxicities correctable (to baseline or grade 1) with repletion and grade 3 creatinine elevation correctable (to grade 1 or less) with IV hydration were not considered DLT's.
- time origin
- During the first cycle of treatment, up to 21 days
- 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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0001
- source section id
- NCT02535312-om-0001
- source outcome index
- 1
- endpoint
- Maximum Tolerated Dose (MTD)
- endpoint definition
- The maximum tolerated dose of TRC102 in combination with 500mg/m\^2 IV of Pemetrex and 60 or 75 mg/m\^2 IV of Cisplatin is based on toxicities observed during the first cycle and is defined as the highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. Dose escalations proceeded according to a standard 3+3 design.
- time origin
- 21 days from start of treatment, up to 2 years
- 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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0002
- source section id
- NCT02535312-om-0002
- source outcome index
- 2
- endpoint
- Number of Subject With Overall Response
- endpoint definition
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR
- time origin
- Up to 8 weeks post-treatment
- 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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0003
- source section id
- NCT02535312-om-0003
- source outcome index
- 3
- endpoint
- Progression-free Survival
- endpoint definition
- Progression-free survival will be summarized as time from first protocol treatment until progression or death from any cause, using the product-limit Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), as at least a 20% increase in the sum of diameters of target lesions, 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 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- time origin
- From start of treatment to time of progression or death from any cause, whichever occurs first, assessed up to at least 1 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Pre-specified in the Study Protocol to collect, analyze, and report data for this Outcome Measure by Phase and not by dose-level.
- 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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0004
- source section id
- NCT02535312-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival
- endpoint definition
- Overall survival will be summarized as time from first protocol treatment until death from any cause, using the product-limit Kaplan-Meier estimator.
- time origin
- From start of treatment to time of death from any cause, assessed up to at least 3 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Pre-specified in the Study Protocol to collect, analyze, and report data for this Outcome Measure by Phase and not by dose-level.
- 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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- regimen
- TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- regimen
- TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- regimen
- TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
- regimen
- TRC102 100/day mg PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (TRC102, Pemetrexed Disodium, Cisplatin)
- regimen
- Patients receive starting dose of TRC102 50 mg/day PO on days 1-4, 500 mg/m\^2 pemetrexed disodium IV over 10 minutes, and 60 or 75 mg/m\^2 of cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue TRC102 and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician. Cisplatin: Given IV TRC102: Given PO Pemetrexed Disodium: Given IV
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- regimen
- TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- regimen
- TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- regimen
- TRC102 100 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
- regimen
- TRC102 100 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0002
- arm key
- OG004
- arm label
- Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
- regimen
- TRC102 50 mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0002#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A (TRC102, Pemetrexed Disodium, Cisplatin) - Phase I
- regimen
- Patients receive 50, 75 or 100 mg/day of TRC102 PO QD on days 1-4, 500 mg/m\^2 of pemetrexed disodium IV over 10 minutes, and 60 or 75 mg/m\^2 of cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue TRC102 and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician.
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B (TRC102, Pemetrexed Disodium) - Phase II
- regimen
- Patients receive 50 mg/day of TRC102 PO QD on days 1-4 and 500 mg/m\^2 of pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue TRC102 and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician.
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02535312-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- harm key
- EG000
- source section id
- NCT02535312-ae
- event group key
- EG000
- event group label
- Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- serious affected
- 0
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
- event definition
- "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation 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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- harm key
- EG001
- source section id
- NCT02535312-ae
- event group key
- EG001
- event group label
- Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
- event definition
- "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation 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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- harm key
- EG002
- source section id
- NCT02535312-ae
- event group key
- EG002
- event group label
- Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- serious affected
- 2
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
- event definition
- "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation 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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- harm key
- EG003
- source section id
- NCT02535312-ae
- event group key
- EG003
- event group label
- Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
- event definition
- "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation 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-malignant-peritoneal-neoplasm-vegzelma-2693c549
- nct id
- NCT02535312
- harm key
- EG004
- source section id
- NCT02535312-ae
- event group key
- EG004
- event group label
- Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
- serious affected
- 9
- serious at risk
- 14
- other affected
- 14
- other at risk
- 14
- frequency threshold
- 0
- collection period
- Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years.
- event definition
- "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation 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