Status:
COMPLETED
Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00779428
Start Date
July 1 2006
End Date
July 1 2013
Last Update
October 12 2015
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115