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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00779428

Enrollment

Registered

2008-10-24

Start date

2006-07-31

Completion date

2013-07-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignancies

Keywords

This is an open-label continuing treatment protocol in patients with advanced malignancies who will receive Tanespimycin

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)

Interventions

DRUGTanespimycin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
There is no Primary Outcome	No formal analysis of efficacy will occur

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026