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

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ClinicalTrials.gov Identifier: NCT00779428
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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)

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: Tanespimycin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Clinical Trial of Tanespimycin in Patients With Advanced Malignancies After Failure of Previous Anti-cancer Therapy Regimens Who Have Participated on a Prior Protocol Investigating Tanespimycin
Study Start Date : July 2006
Actual Primary Completion Date : March 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: A1 Drug: 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 Name: BMS-722782




Primary Outcome Measures :
  1. There is no Primary Outcome [ Time Frame: No formal analysis of efficacy will occur ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779428


Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00779428     History of Changes
Other Study ID Numbers: CA200-002
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015

Keywords provided by Bristol-Myers Squibb:
This is an open-label continuing treatment protocol in patients with advanced malignancies who will receive Tanespimycin

Additional relevant MeSH terms:
Neoplasms