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NCT00678132 · ClinicalTrials.gov registry record · Phase 1
AZD2281 and Cisplatin Plus Gemcitabine to Treat Solid Tumor Cancers
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00678132: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00678132 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00678132, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
Background: * AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is involved in repairing DNA damage; PARP inhibitors interfere with that process. * Cisplatin and gemcitabine are approved by the United States Food and Drug Administration to treat certain cancers. Objectives: * To determine the optimum doses of AZD2281, cisplatin and gemcitabine in combination that can safely be given to patients with solid tumor cancers. * To evaluate the response of the tumor to the drug combination and determine the side effects of the treatment. Eligibility: -Patients 18 years or older with an advanced solid tumor cancer for whom standard treatments are not effective. Design: * In this dose escalation study, the first small group of patients receives the smallest study doses of the study drugs. Subsequent groups receive incrementally higher doses as long as the preceding group does not experience unacceptable side effects. When the highest safe dose is determined, additional patients entering the study receive that dose. * Patients receive treatment in 21-day cycles as follows: * Days 1-4: AZD2281 by mouth twice a day * Day 3: gemcitabine thorough a vein over 1 hour; then cisplatin through a vein over 1 hour. * Day 10: gemcitabine through a vein over 1 hour. * Evaluations during treatment include the following: * Physical examination, vital signs check and blood tests every 3 weeks. * CT scans every 6 weeks to evaluate the tumor. * Treatment may continue until it is no longer beneficial.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG AZD 2281
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-04-24 |
| Est. Completion | 2010-11-23 |
| Phase | Phase 1 |
What the finished NCT00678132 record still lists
NCT00678132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT00678132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00678132 about?
NCT00678132 is a clinical study titled "AZD2281 and Cisplatin Plus Gemcitabine to Treat Solid Tumor Cancers". Background: * AZD2281 is an experimental drug in a class of agents called PARP inhibitors. PARP is a protein that is involved in repairing DNA damage; PARP inhibitors interfere with that process. * Cisplatin and gemcitabine are approved by the United States Food and Drug Administration to treat cer...
What is the current status of trial NCT00678132?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2008-04-24. Estimated completion is 2010-11-23.
What interventions are being tested in trial NCT00678132?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), AZD 2281 (DRUG).
Who is sponsoring clinical trial NCT00678132?
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 NCT00678132's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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