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Safety Study of ABT-263 in Combination With Paclitaxel in Subjects With Solid Tumors

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
Abbott Identifier:
First received: April 29, 2009
Last updated: August 7, 2012
Last verified: June 2012
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
Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Subject must be greater than or equal to 18 years of age.
  2. Subject must have a histologically and/or cytologically documented cancer for which paclitaxel has been determined an appropriate therapy, per the Investigator.
  3. 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.
  4. Subject has an Eastern Cooperative Oncology Group (ECOG) score of less than or equal to 1.
  5. Subject must have adequate bone marrow, renal and hepatic function per protocol defined local laboratory testing parameters.

Exclusion Criteria

  1. 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.
  2. 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.
  3. The subject has active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
  4. 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).
  5. 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
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Please refer to this study by its identifier: NCT00891605

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
Genentech, Inc.
Study Director: Mack Mabry, MD Abbott
  More Information

Responsible Party: Abbott Identifier: NCT00891605     History of Changes
Other Study ID Numbers: M10-589
Study First Received: April 29, 2009
Last Updated: August 7, 2012

Keywords provided by Abbott:
Solid Tumors

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017