Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00678132
The ClinicalTrials.gov registry entry for NCT00678132 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 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 3 interventions - of which Cisplatin is the first listed.
NCT00678132 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.