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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). 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 |
What the finished NCT01445522 record still lists
NCT01445522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclophosphamide is the first listed.
NCT01445522 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01445522's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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