A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors

Expired Study

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Boston, Massachusetts 02115

Purpose:

An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

Study summary:

This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.

Criteria:

Inclusion Criteria: - Patients must be documented to be refractory or not candidates for current approved therapies. - Must have anECOG status 0-2. - Peripheral neuropathy ?2. - Must have acceptable organ and marrow function per protocol parameters. - No clinically significant ventricular arrythmias or ischemia. Exclusion Criteria: - Must not be pregnant or breastfeeding. -No chemotherapy or radiation within 3 weeks.. - No previous radiation to >25% of total bone marrow. - No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation. - No primary brain tumors or active brain metastases. - No use of any investigational agents within 4 weeks. - No treatment with chronic immunosuppressants. - No uncontrolled, intercurrent illness.

Study is Available At:

Original ID:

9090-01

NCT ID:

NCT00688116

Secondary ID:

Study Acronym:

Brief Title:

Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors

Official Title:

A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors

ClinicalTrials.gov Link:

http://clinicaltrials.gov/show/NCT00688116

Overall Status:

Active, not recruiting

Study Phase:

Phase 1

Genders:

Both

Minimum Age:

25 Years

Maximum Age:

N/A

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Synta Pharmaceuticals Corp.

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classificatio

Number of Arms:

Number of Groups:

Total Enrollment:

Enrollment Type:

Anticipated

Study Dates

Start Date:	October 2007
Completion Date:	November 2014
Completion Type:	Anticipated
Primary Completion Date:	April 2014
Primary Completion Type:	Actual
Verification Date:	September 2014
Last Changed Date:	September 17, 2014
First Received Date:	May 28, 2008

Study Outcomes

Outcome Type:	Primary Outcome
Measure:	The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug.
Time Frame:	Cycle 1
Safety Issues:	True

Study Interventions

Intervention Type:	Drug
Name:	STA 9090 (ganetespib)
Description:	This is a dose-escalation study. The first cohort will consist of three patients who will receive 2 mg/m2 of STA 9090 (ganetespib) during a 1-hour infusion 2 times per week (e.g., [Monday, Thursday] or [Tuesday, Friday]) for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive 4, 7, 10, 14, 19, 25, 33, 40 and 48 mg/m2 provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Further dose increments will be approximately 20% over
Arm Name:	ganetespib

Study Arms

Study Arm Type:	Experimental
Arm Name:	ganetespib

Study Agencies

Agency Class:	Industry
Agency Type:	Lead Sponsor
Agency Name:	Synta Pharmaceuticals Corp.

Sample and Retention Information

There are no available Sample and Retention Information

Study Links

There are no available Study Links

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

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A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors

Purpose:

Study summary:

Criteria:

Study is Available At:

Original ID:

NCT ID:

Secondary ID:

Study Acronym:

Brief Title:

Official Title:

ClinicalTrials.gov Link:

Overall Status:

Study Phase:

Genders:

Minimum Age:

Maximum Age:

Quick Facts

Study Source:

Oversight Authority:

Reasons Why Stopped:

Study Type:

Study Design:

Number of Arms:

Number of Groups:

Total Enrollment:

Enrollment Type:

Study Dates

Study Outcomes

Study Interventions

Study Arms

Study Agencies

Sample and Retention Information

There are no available Sample and Retention Information

Study Links

There are no available Study Links

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

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