Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI	AECM-03099 AECM-CA163402, AECM-NMC-03-10-277C, NCT00096317

Objectives

Primary

1. Determine the effect of ketoconazole on the pharmacokinetics of ixabepilone in patients with advanced solid tumors.

Secondary

1. Determine the safety of ixabepilone when administered alone and in combination with ketoconazole in these patients.
2. Determine, preliminarily, the antitumor activity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed solid tumor



• Unresponsive to currently available therapy OR no known effective treatment exists



• Measurable or nonmeasurable disease



• Brain metastases allowed, provided the following criteria are met:
  • Completed cranial radiotherapy at least 4 weeks ago
  • Stable or reduced brain metastases by brain imaging*
  • Clinically stable disease AND no steroid therapy within the past 2 weeks

   [Note: *Baseline brain imaging is not required for patients with no signs or symptoms of brain metastasis]

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No more than 3 prior chemotherapy regimens
• No other concurrent chemotherapy (standard or investigational)

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered
• No prior radiotherapy to > 25% of major bone-marrow containing areas (e.g., pelvis or lumbar spine)

Surgery

• At least 1 week since prior minor surgery and recovered
• At least 3 weeks since prior major surgery and recovered

Other

• More than 2 weeks since prior drugs that would inhibit or stimulate drug metabolism

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Expected Enrollment

A total of 3-35 patients will be accrued for this study.

Outcomes

Effect of ketoconazole on the pharmacokinetics of ixabepilone

Safety of ixabepilone with and without ketoconazole
Antitumor activity

Outline

This is an open-label, dose-escalation study of ixabepilone.

During course 1, patients receive oral ketoconazole on days 0-5 and ixabepilone IV over 3 hours on day 1. During course 2 and subsequent courses, patients receive only ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of at least 3 patients receive escalating doses of ixabepilone during course 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. At least 12 patients are treated at the MTD.

Goel S, Cohen M, Cömezoglu SN, et al.: The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of ixabepilone: a first in class epothilone B analogue in late-phase clinical development. Clin Cancer Res 14 (9): 2701-9, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Sridhar Mani, MD, Protocol chair		Ph: 718-904-2488 Email: smani@montefiore.org

Registry Information
Official Title		Effect Of Ketoconazole On The Pharmacokinetics Of BMS-247550 In Patients With Advanced Cancer
Trial Start Date		2003-03-30
Registered in ClinicalTrials.gov		NCT00096317
Date Submitted to PDQ		2004-09-17
Information Last Verified		2006-01-18
NCI Grant/Contract Number		P30-CA13330

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