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

This study has been completed.
Sponsor:
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
  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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Navitoclax
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014