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NCT02535312 · ClinicalTrials.gov registry record · Phase 1
Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin
A Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 14
- Study locations
NCT02535312: Active Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT02535312 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (83% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02535312, a Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 14
- Study locations
Study Summary
This phase I/II trial studies the side effects and the best dose of methoxyamine when given together with cisplatin and pemetrexed disodium and to see how well it works in treating patients with solid tumors or mesothelioma that have spread to other places in the body and usually cannot be cured or controlled with standard treatment (advanced), or mesothelioma that does not respond to pemetrexed disodium and cisplatin or carboplatin (refractory). Methoxyamine may shrink the tumor and may also help cisplatin and pemetrexed disodium work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as cisplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving methoxyamine together with cisplatin and pemetrexed disodium may be a better treatment for solid tumors or mesothelioma than methoxyamine and pemetrexed disodium.
Primary Outcome
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 o
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed Disodium
- DRUG Methoxyamine
Study Locations (14)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Keck Medical Center of USC Pasadena - Pasadena
- University of California Davis Comprehensive Cancer Center - Sacramento
Tennessee
- Vanderbilt Breast Center at One Hundred Oaks - Nashville
- Vanderbilt University/Ingram Cancer Center - Nashville
Colorado
- UCHealth University of Colorado Hospital - Aurora
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Minnesota
- Mayo Clinic in Rochester - Rochester
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-03-08 |
| Est. Completion | 2026-10-15 |
| Phase | Phase 1 |
What the registry record for NCT02535312 still lists
NCT02535312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (83% lower).
The record links to 7 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT02535312 lists 14 locations in 9 states (California, Tennessee, Colorado).
Frequently Asked Questions
What is clinical trial NCT02535312 about?
NCT02535312 is a clinical study titled "Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin". This phase I/II trial studies the side effects and the best dose of methoxyamine when given together with cisplatin and pemetrexed disodium and to see how well it works in treating patients with solid tumors or mesothelioma that have spread to other places in the body and usually cannot be cured or ...
What is the current status of trial NCT02535312?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2016-03-08. Estimated completion is 2026-10-15.
What conditions does trial NCT02535312 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Solid Neoplasm, Recurrent Peritoneal Malignant Mesothelioma, Recurrent Pleural Malignant Mesothelioma.
What interventions are being tested in trial NCT02535312?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed Disodium (DRUG), Methoxyamine (DRUG).
Who is sponsoring clinical trial NCT02535312?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02535312 being conducted?
This trial has 14 study locations across California, Colorado, Maryland, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02535312's enrollment target sits among peer trials
30 87th of 108 higher than 21 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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