Safety Study of ABT-263 in Combination With Paclitaxel in Subjects With Solid Tumors
This study has been completed.
Sponsor:
Abbott
Collaborator:
Genentech
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00891605
First received: April 29, 2009
Last updated: August 7, 2012
Last verified: June 2012
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Purpose
Safety study of ABT-263 in Combination with Paclitaxel in Subjects with Solid Tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: ABT-263 Drug: paclitaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Paclitaxel in the Treatment of Subjects With Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Safety Assessment [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule of ABT-263 in combination with Paclitaxel
- Efficacy Assessment [ Time Frame: Bi-monthly ] [ Designated as safety issue: No ]Evaluate preliminary data regarding objective response rate (ORR), progression free survival (PFS), time to tumor progression (TTP), overall survival (OS), duration of overall response, and, ECOG performance status
| Enrollment: | 19 |
| Study Start Date: | July 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Paclitaxel and ABT-263 |
Drug: ABT-263
150 mg of ABT-263 is taken orally once daily on Days 1-3 out of each 21 day cycle. This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.
Other Name: Navitoclax
Drug: paclitaxel
175 mg/m2 over 3 hours of paclitaxel will be given by intravenous infusion on Day 1 of each 21 day cycle. Note - The dose and schedule is subject to change based on the toxicities observed. Other Name: Taxol
|
Detailed Description:
A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination with Paclitaxel in the Treatment of Subjects with Solid Tumors.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Subject must be greater than or equal to 18 years of age.
- Subject must have a histologically and/or cytologically documented cancer for which paclitaxel has been determined an appropriate therapy, per the Investigator.
- Subjects with brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of CNS disease progression as determined by CT or MRI within 28 days prior to the first dose of study drug.
- Subject has an Eastern Cooperative Oncology Group (ECOG) score of less than or equal to 1.
- Subject must have adequate bone marrow, renal and hepatic function per protocol defined local laboratory testing parameters.
Exclusion Criteria
- The subject has an underlying, predisposing condition of bleeding or currently exhibits signs of bleeding. The subject has a recent history of thrombocytopenia associated with bleeding within 1 year prior to first dose of study drug.
- Subject is currently receiving or requires anticoagulation therapy (e.g., warfarin at any dose) or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications such as heparin that are used to maintain the patency of a central intravenous catheter.
- The subject has active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
- The subject has active immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), or a history of being refractory to platelet transfusions (within 1 year prior to the first dose of study drug).
- The subject has a significant history of cardiovascular (e.g., MI, thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891605
Locations
| United States, Maryland | |
| Site Reference ID/Investigator# 22061 | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Michigan | |
| Site Reference ID/Investigator# 52736 | |
| Detroit, Michigan, United States, 48202 | |
| United States, New Jersey | |
| Site Reference ID/Investigator# 13421 | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, North Carolina | |
| Site Reference ID/Investigator# 12862 | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Abbott
Genentech
Investigators
| Study Director: | Mack Mabry, MD | Abbott |
More Information
No publications provided
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00891605 History of Changes |
| Other Study ID Numbers: | M10-589 |
| Study First Received: | April 29, 2009 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott:
|
Paclitaxel Solid Tumors |
Additional relevant MeSH terms:
|
Neoplasms Paclitaxel Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013