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Sponsors and Collaborators: |
Abbott Genentech |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00891605 |
The is a Phase 1 study assessing the safety profile of ABT-263 in combination with Carbo-taxol, studying the pharmacokinetic interaction between ABT-263 with Carbo-taxol and to determine the maximum tolerated dose (MTD) of ABT-263 in combination with Carbo-taxol.
Condition | Intervention | Phase |
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Solid Tumor |
Drug: ABT-263 Drug: paclitaxel Drug: Carboplatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Carbo-Taxol (Carboplatin/Paclitaxel) in the Treatment of Subjects With Solid Tumors |
Estimated Enrollment: | 25 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Carbo-taxol (Carboplatin/Paclitaxel): Experimental |
Drug: paclitaxel
175 mg/m2 over 3 hours of paclitaxel will be given by intravenous infusion on Day 1 of each 21 day cycle
Drug: Carboplatin
Carboplatin (AUC 6 over 1 hour) will be given by intervenous infusion on Day 1 immediately after the paclitaxel infusion.
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ABT-263: Experimental |
Drug: ABT-263
150 mg of ABT-263 is taken orally once daily on Days 1-5 out of each 21 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must have adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:
Hepatic function and enzymes:
Exclusion Criteria:
Exhibits evidence of other clinically significant uncontrolled condition; active systemic fungal infection;diagnosis of fever & neutropenia w/i
1 week of study drug administration.
Contact: Alexis A Cunningham, B.A. | 847-937-1225 | alexis.cunningham@abbott.com |
Contact: Julie Sicam, B.S. | 847-937-5363 | julie.sicam@abbott.com |
United States, New Jersey | |
The Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08901 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Study Director: | Andrew Krivoshik, MD, PhD | Abbott |
Responsible Party: | Abbott ( Andrew Krivoshik, MD, PhD, Medical Director ) |
Study ID Numbers: | M10-589 |
Study First Received: | April 29, 2009 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00891605 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Paclitaxel Tubulin Modulators Antimitotic Agents Carboplatin Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Paclitaxel Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Carboplatin Antineoplastic Agents, Phytogenic Pharmacologic Actions |