Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety Assessment

Outcome Description:

Evaluate safety at the defined recommended Phase 2 dose (RPTD) and schedule of ABT-263 in combination with Paclitaxel

Outcome Time Frame:

Weekly

Safety Issue:

Yes

Principal Investigator

Mack Mabry, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott

Authority:

United States: Food and Drug Administration

Study ID:

M10-589

NCT ID:

NCT00891605

Start Date:

July 2009

Completion Date:

July 2012

Related Keywords:

  • Solid Tumors
  • Paclitaxel
  • Solid Tumors
  • Neoplasms

Name

Location

Site Reference ID/Investigator# 22061Baltimore, Maryland  21231
Site Reference ID/Investigator# 52736Detroit, Michigan  48202
Site Reference ID/Investigator# 13421New Brunswick, New Jersey  08901
Site Reference ID/Investigator# 12862Durham, North Carolina  27710