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NCT01851369 · ClinicalTrials.gov registry record · Phase 1
TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
NCT01851369: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01851369 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 93 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01851369, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
Study Summary
Background: \- Methoxyamine hydrochloride (TRC102) is a new cancer treatment drug that may help improve the results of chemotherapy. It blocks tumor cells' attempts to repair damaged deoxyribonucleic acid (DNA), which may allow chemotherapy to kill the cells more easily. Researchers want to see how well it works with temozolomide, a chemotherapy drug that is designed to damage tumor cell DNA. These drugs will be given to people who have advanced solid tumors or lymphomas that have not responded to earlier treatments. Objectives: \- To test the safety and effectiveness of TRC102 and temozolomide for advanced solid tumors and lymphomas. Eligibility: \- Individuals at least 18 years of age who have advanced solid tumors or lymphomas that have not responded to earlier treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor samples may also be collected. The size and location of the tumors will be determined with imaging studies. * Participants will take TRC102 and temozolomide for 28-day cycles of treatment. They will take temozolomide and TRC 102 by mouth once a day on days 1-5. Participants will keep a diary to record doses and any side effects. * Treatment will be monitored with frequent blood tests and imaging studies. Tumor samples will also be collected. * Participants will continue their treatment as long as the cancer does not grow and there are no severe side effects.
Primary Outcome
Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable Disease (SD) is neither suffi
Interventions
- DIAGNOSTIC_TEST CT scan
- OTHER Prochlorperazine
- DRUG TRC102
- OTHER Lomotil
- OTHER Metoclopramide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2013-07-12 |
| Est. Completion | 2023-08-01 |
| Phase | Phase 1 |
What the finished NCT01851369 record still lists
NCT01851369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% higher).
The record links to 0 conditions, and to 5 interventions - of which CT scan is the first listed.
NCT01851369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01851369 about?
NCT01851369 is a clinical study titled "TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas". Background: \- Methoxyamine hydrochloride (TRC102) is a new cancer treatment drug that may help improve the results of chemotherapy. It blocks tumor cells' attempts to repair damaged deoxyribonucleic acid (DNA), which may allow chemotherapy to kill the cells more easily. Researchers want to see how...
What is the current status of trial NCT01851369?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2013-07-12. Estimated completion is 2023-08-01.
What interventions are being tested in trial NCT01851369?
The interventions under investigation include: CT scan (DIAGNOSTIC_TEST), Prochlorperazine (OTHER), TRC102 (DRUG), Lomotil (OTHER), Metoclopramide (OTHER).
Who is sponsoring clinical trial NCT01851369?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01851369's enrollment target sits among peer trials
93 624th of 2000 higher than 1,376 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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