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Phase I Study of the Hsp90 Inhibitor, AT13387, in Adults With Refractory Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of the Hsp90 Inhibitor, AT13387, in Adults With Refractory Solid Tumors



- 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.


- 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.

Inclusion Criteria


- 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


- 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)


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of Hsp90 inhibitor AT13387 (AT13387)

Safety Issue:


Principal Investigator

Shivaani Kummar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Medical Oncology Branch



Study ID:




Start Date:

November 2010

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



NCI - Developmental Therapeutics Clinic Bethesda, Maryland  20892