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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Advanced Malignancies

Treatments

Drug: Tanespimycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00779428

CA200-002

Details and patient eligibility

About

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)

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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