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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01851369
The ClinicalTrials.gov registry entry for NCT01851369 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which CT scan is the first listed.
NCT01851369 reports 0 study locations.
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.
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