Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin
Completed · Phase 2
Conditions studied: Advanced Malignancies
In brief
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)
Key facts
- Study ID
- NCT00779428
- Run by
- Bristol-Myers Squibb
- People needed
- 6
- Starts
- 2006-07-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2015-10-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.