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

Solid Tumors Clinical Trial

Official title:

A Phase 1 Safety and Pharmacokinetic Study of ABT-263 in Combination With Paclitaxel in the Treatment of Subjects With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891605
• Other study ID #: M10-589
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2009
• Last updated: November 17, 2017
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: June 2012
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Genentech, Inc.

References & Publications (1)

Vlahovic G, Karantza V, Wang D, Cosgrove D, Rudersdorf N, Yang J, Xiong H, Busman T, Mabry M. A phase I safety and pharmacokinetic study of ABT-263 in combination with carboplatin/paclitaxel in the treatment of patients with solid tumors. Invest New Drugs — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessment	Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule of ABT-263 in combination with Paclitaxel	Weekly
Primary	Efficacy Assessment	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	Bi-monthly