Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors

NCT00096317 | Completed Phase 1 FDA Drug

• 5 other identifiers: CDR0000393439P30CA013330AECM-03099AECM-CA163402AECM-NMC-03-10-277C
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving ixabepilone with ketoconazole may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving ixabepilone together with ketoconazole and to see how well they work in treating patients with advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Effect of ketoconazole on the pharmacokinetics of ixabepilone

Secondary Outcomes (2)

• Safety of ixabepilone with and without ketoconazole

• Antitumor activity

Interventions

ixabepilone DRUG

ketoconazole DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 (Baseline brain imaging is not required for patients with no signs or symptoms of brain metastasis) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• Goel S, Cohen M, Comezoglu SN, Perrin L, Andre F, Jayabalan D, Iacono L, Comprelli A, Ly VT, Zhang D, Xu C, Humphreys WG, McDaid H, Goldberg G, Horwitz SB, Mani S. 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. 2008 May 1;14(9):2701-9. doi: 10.1158/1078-0432.CCR-07-4151.

  PMID: 18451235 RESULT

MeSH Terms

Interventions

ixabepilone; Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sridhar Mani, MD

  Albert Einstein College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: March 1, 2003
• Primary Completion: December 5, 2005
• Study Completion: December 5, 2005
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)