AZD2281 and Cisplatin Plus Gemcitabine to Treat Solid Tumor Cancers
Public ClinicalTrials.gov record NCT00678132. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Combination Study of AZD2281 and Cisplatin Plus Gemcitabine in Adults With Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00678132
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 23 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 23, 2008
- Primary completion
- Nov 22, 2010
- Completion
- Nov 22, 2010
- Last update posted
- Jul 4, 2018
2008 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00678132, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 4, 2018 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00678132 live on ClinicalTrials.gov.