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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00891605
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : November 21, 2017
Genentech, Inc.
Information provided by (Responsible Party):

Brief Summary:
Safety study of ABT-263 in Combination with Paclitaxel in Subjects with Solid Tumors.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: ABT-263 Drug: paclitaxel Phase 1

Detailed Description:
A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination with Paclitaxel in the Treatment of Subjects with Solid Tumors.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety Assessment [ Time Frame: Weekly ]
    Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule of ABT-263 in combination with Paclitaxel

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00891605

Sponsors and Collaborators
Genentech, Inc.
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Study Director: Mack Mabry, MD Abbott
Publications of Results:
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Responsible Party: AbbVie Identifier: NCT00891605    
Other Study ID Numbers: M10-589
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: June 2012
Keywords provided by AbbVie:
Solid Tumors
Additional relevant MeSH terms:
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Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action