Clinical Trial of Continuing Treatment for Patients Who Have Participated on a Prior Protocol Investigating Tanespimycin
NCT ID: NCT00779428
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
6 participants
INTERVENTIONAL
2006-07-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A1
Tanespimycin
Solution, IV
This is a one arm study with the dose, frequency, and duration assigned as per previous protocol (KOS-953, 17-AAG)
Interventions
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Tanespimycin
Solution, IV
This is a one arm study with the dose, frequency, and duration assigned as per previous protocol (KOS-953, 17-AAG)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA200-002
Identifier Type: -
Identifier Source: org_study_id
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