Solid Tumor
Phase I Study of the HSP-90 Inhibitor, AT13387, in Adults With Refractory Solid Tumors
NCI-11-C-0029, NCT01245218
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Investigator(s): |
Shivaani Kummar, M.D., F.A.C.P. Principal Investigator Phone: 301-435-0517 Fax: 301-496-0826 kummars@mail.nih.gov
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Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov
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Lemual Clayborn Referral Coordinator Phone: 301-451-0992 Fax: 301-496-0826 claybornlr@mail.nih.gov
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Ramya Parthasarathy, B.S.N., R.N., O.C.N. Research Nurse Phone: 301-594-4949 Fax: 301-480-7281 parthasarathyr@mail.nih.gov
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Key Eligibility Criteria:
- Histologically confirmed diagnosis of a solid tumor
- Failed at least one line of prior therapy or have a disease for which no standard curative therapy exists
- Enrolling in the expansion phase; must have disease amenable to biopsy with willingness to undergo pre- and post-treatment biopsies
- Must have measurable or evaluable disease
- Optional Her-2 scan available
- Absolute neutrophil count ≥ 1,500/microL
- Platelets ≥ 100,000/microL
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)
- No clinically significant illness or psychiatric illness/social situations that would limit compliance with study requirements
Study Outline:
- Screening with a physical examination, medical history, and CT scans, as well as blood and urine samples
- AT13387 will be administered intravenously (through a vein), on 2 consecutive days, 3 out of 4 weeks, every 28 days (i.e., on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle)
- Cycles continue in the absence of disease progression or unacceptable toxicity
- CT scans will be performed at baseline and every two cycles for restaging
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 9/12/12
Updated: 9/27/12