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NCT01445522 · ClinicalTrials.gov registry record · Phase 1
ABT-888 Plus Metronomic Cyclophosphamide to Treat Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT01445522: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01445522 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445522, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
Background: * Cyclophosphamide (CP) is a drug approved by the Food and Drug Administration for the treatment of certain cancers. It works by causing DNA damage, resulting in cell death, including cancer cells. * ABT-888 is an experimental drug that has been given to a small number of patients. It works by preventing DNA repair in tumor cells. Objectives: * To test the safety of the combination of ABT-888 and CP, and to determine the dose of each drug that can be given together to patients with cancer. * To see how the body handles ABT-888 when given together with CP * To evaluate the anti-tumor response of the drug combination. Eligibility: * Adults with solid tumors or lymphoid cancers (lymphoma and chronic lymphocytic leukemia) whose disease does not respond to standard treatments. Design: * Patients take ABT-888 by mouth once a day for 7, 14 or 21 days, depending on the dose level assigned to the individual patient. * Patients take CP by mouth once a day every day in 21-day cycles. (Some patients take CP for 14 days only.) * Patients undergo tests and procedures periodically during the study, including: * Clinic visit and physical examination at the beginning of each cycle * Blood and urine tests, electrocardiogram, measurement of vital signs * CT scans, MRI scans or ultrasound tests to check the response of the tumor to treatment * Tumor biopsies (optional) * Bone marrow aspiration and biopsy
Interventions
- DRUG Cyclophosphamide
- DRUG ABT-888
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-12-03 |
| Est. Completion | 2012-07-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01445522
The ClinicalTrials.gov registry entry for NCT01445522 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 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 2 interventions - of which Cyclophosphamide is the first listed.
NCT01445522 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01445522 about?
NCT01445522 is a clinical study titled "ABT-888 Plus Metronomic Cyclophosphamide to Treat Cancer". Background: * Cyclophosphamide (CP) is a drug approved by the Food and Drug Administration for the treatment of certain cancers. It works by causing DNA damage, resulting in cell death, including cancer cells. * ABT-888 is an experimental drug that has been given to a small number of patients. It w...
What is the current status of trial NCT01445522?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2008-12-03. Estimated completion is 2012-07-03.
What interventions are being tested in trial NCT01445522?
The interventions under investigation include: Cyclophosphamide (DRUG), ABT-888 (DRUG).
Who is sponsoring clinical trial NCT01445522?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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