Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to provide treatment to patients who have participated on a prior protocol investigating Tanespimycin (KOS-953,17-AAG)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Inclusion Criteria:

• Age >= 18 years

• Participated in and completed a previous Tanespimycin protocol without evidence of unacceptable toxicity and is deemed by the Investigator to be deriving benefit from the Tanespimycin drug as defined in the previous protocol

• All patients must rollover to this continuation protocol within 30 days of the last dose of Tanespimycin in the previous protocol, unless previously approved by the Medical Monitor

• All Adverse Events from the prior protocol, must have resolved to NCI CTCAE (v. 3.0) Grade <= 2

• The following laboratory results, within 10 days of Tanespimycin administration:

• Hemoglobin >= 8 g/dL

• Absolute neutrophils count >= 1.0x 10*9* /L

• Platelet count >= 50 x 10*9* /L

• Serum bilirubin <= 2 x ULN

• AST <= 2.5 ULN

• Serum creatinine <= 2 x ULN

• ECOG performance status of 0, 1 or 2

• Signed informed consent

Exclusion Criteria:

• Pre-existing neuropathy of CTCAE Grade >= 3 due to any cause

• Documented hypersensitivity reaction of CTCAE Grade >= 3 to prior therapy containing Cremophor (for those patients receiving Tanespimycin Injection)

• Pregnant or breast-feeding women

• Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic), excluding Tanespimycin within 21 days prior to receipt of study medication

• Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient