AT13387 in Treating Patients With Refractory Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01245218
First received: November 19, 2010
Last updated: November 25, 2010
Last verified: November 2010
  Purpose

RATIONALE: AT13387 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I clinical trial is studying the side effects and best dose of AT13387 in treating patients with refractory solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: Hsp90 inhibitor AT13387
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of the Hsp90 Inhibitor, AT13387, in Adults With Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and tolerability of Hsp90 inhibitor AT13387 (AT13387) [ Designated as safety issue: Yes ]
  • Maximum-tolerated dose and recommended phase II dose of AT13387 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of AT13387 [ Designated as safety issue: No ]
  • Pharmacodynamic markers of Hsp90 inhibition and modulation of Hsp90 client proteins by AT13387 in tumor tissue, serum, and PBMCs [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: November 2010
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Define the safety and tolerability of Hsp90 inhibitor AT13387 (AT13387) in adult patients with refractory solid tumors.
  • Establish the maximum-tolerated dose (MTD) of AT13387 in adult patients with refractory solid tumors.

Secondary

  • Determine the pharmacokinetics of AT13387 in patients with refractory solid tumors.
  • Assess pharmacodynamic markers of Hsp90 inhibition and modulation of Hsp90 client proteins by AT13387 in tumor tissue, serum, and PBMCs.

OUTLINE: This is a dose-escalation study followed by an expansion phase.

Patients receive Hsp90 inhibitor AT13387 IV over 1 hour on days 1, 2, 8, 9, 15, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood, urine, and tissue collection at baseline and periodically during the study for pharmacokinetic and pharmacodynamic studies.

After completion of study therapy, patients are followed up for 30 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor malignancy

    • Metastatic or unresectable disease for which no standard curative measures exist OR failed ≥ 1 line of standard therapy
  • Measurable or evaluable disease
  • Archived tumor tissue must be HER2/neu ≥ 1+ by IHC (expansion phase)

    • Disease amenable to biopsy
  • No known brain metastases or carcinomatous meningitis

    • Brain metastatic disease that has remained stable for ≥ 2 months after treatment, without steroids or anti-seizure medications, allowed at the discretion of the principal investigator

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine < 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) prior to, during, and for 2 months after completion of study
  • Willingness to undergo pre- and post-treatment biopsies (expansion phase)
  • No clinically significant intercurrent illnesses including, but not limited to, any of the following:

    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Uncontrolled cardiac arrhythmia
    • Psychiatric illness and/or social situations that would limit compliance with study requirements
  • QTc > 450 msec (for men) or QTc > 470 msec (for women)

PRIOR CONCURRENT THERAPY:

  • At least 4 weeks since prior chemotherapy, radiotherapy, or biologic therapy (6 weeks for nitrosoureas or mitomycin C)
  • At least 2 weeks since any prior drug in an exploratory IND/phase 0 study
  • Recovered from prior toxicity or adverse events
  • Concurrent bisphosphonates for any cancer allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245218

Locations
United States, Maryland
NCI - Developmental Therapeutics Clinic Recruiting
Bethesda, Maryland, United States, 20892
Contact: Shivaani Kummar, MD     301-435-5402     kummars@mail.nih.gov    
Sponsors and Collaborators
Investigators
Principal Investigator: Shivaani Kummar, MD NCI - Medical Oncology Branch
  More Information

Additional Information:
No publications provided

Responsible Party: Shivaani Kummar, NCI - Medical Oncology Branch
ClinicalTrials.gov Identifier: NCT01245218     History of Changes
Obsolete Identifiers: NCT01246102
Other Study ID Numbers: CDR0000689129, NCIDTC-11-C-0029
Study First Received: November 19, 2010
Last Updated: November 25, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013