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NCT00553189 · ClinicalTrials.gov registry record · Phase 1
Safety Study of ABT-888 Plus Topotecan Hydrochloride to Treat Patients With Solid Tumors and Lymphomas
A Phase 1 study of Solid Tumors and Lymphomas, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT00553189 is a Phase 1 study of Solid Tumors and Lymphomas that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00553189, a Phase 1 study of Solid Tumors and Lymphomas, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * PARP is an enzyme that is involved in the repair of damage to DNA. Levels of the enzyme are higher in tumor cells than in normal cells, and may play a part in resistance to cancer chemotherapy and radiation therapy. ABT-888 is an experimental drug that inhibits PARP and may help to increase the effectiveness of cancer treatments designed to damage DNA in cancer cells. * Topotecan is a drug approved by the Food and Drug Administration for treating certain cancers. * This dose escalation study will test the two drugs at successively higher doses in small groups of patients until the highest safe dose is determined. Objectives: * To test the safety of the combination of ABT-888 and Topotecan (TPT) and determine the highest dose of each drug that can be safely given to humans. This is the maximum tolerated dose (MTD). * To learn how the combination of ABT-888 and TPT works in humans and how the body handles the drugs. * To determine the side effects of the combination of ABT-888 and TPT at the tested doses. Eligibility: -Patients with solid tumors, lymphomas and chronic lymphocytic leukemia whose disease has progressed following standard therapy or for whom standard treatments are not available. Design: * ABT-888 and TPT are given in 21-day treatment cycles. At the start of the study, TPT is infused through a vein over 30 minutes about a week before cycle 1 starts. Starting on day 1 of cycle 1, ABT-888 is given by mouth twice a day for 7 days. TPT is given through a vein daily for 4 days starting on day 2. After the last dose of ABT-888 day 7, no more treatment is given for the rest of the 21-day cycle. * For the remaining cycles, ABT-888 is given twice a day by mouth on days 1 to 7 of each cycle, and TPT is given through a vein daily on days 1 to 5 of each cycle. * The first three to six patients enrolled in the study take the smallest study dose of the drugs. If they do not develop significant adverse side effects, successive small groups of patie
Conditions Studied
Interventions
- DRUG Topotecan
- DRUG ABT-888
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-08-09 |
| Est. Completion | 2011-09-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00553189
The ClinicalTrials.gov registry entry for NCT00553189 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (89% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Topotecan is the first listed.
NCT00553189 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00553189 about?
NCT00553189 is a clinical study titled "Safety Study of ABT-888 Plus Topotecan Hydrochloride to Treat Patients With Solid Tumors and Lymphomas". Background: * PARP is an enzyme that is involved in the repair of damage to DNA. Levels of the enzyme are higher in tumor cells than in normal cells, and may play a part in resistance to cancer chemotherapy and radiation therapy. ABT-888 is an experimental drug that inhibits PARP and may help to in...
What is the current status of trial NCT00553189?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2007-08-09. Estimated completion is 2011-09-28.
What conditions does trial NCT00553189 study?
This clinical trial studies the following conditions: Solid Tumors, Lymphomas.
What interventions are being tested in trial NCT00553189?
The interventions under investigation include: Topotecan (DRUG), ABT-888 (DRUG).
Who is sponsoring clinical trial NCT00553189?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00553189 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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