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Completed

NCT Number: NCT00779428

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

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tanespimycin

Drug

Solution, IV

This is a one arm study with the dose, frequency, and duration assigned as per previous protocol (KOS-953, 17-AAG)

Other names: BMS-722782

Primary outcomes

  1. There is no Primary Outcome

    Time frame: No formal analysis of efficacy will occur

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Oct 24, 2008
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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