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

NCT ID: NCT00687934

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-10-31

Brief Summary

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

Conditions

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ganetespib

Ganetespib once weekly infusion, dose escalation study, with treatment until progression

Group Type: EXPERIMENTAL

STA-9090

Intervention Type: DRUG

This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

Interventions

STA-9090

This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must be documented to be refractory or not candidates for current approved therapies.
• Must have an ECOG status 0-2.
• Peripheral neuropathy < or = 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.
• Chemotherapy or radiation within 3 weeks.
• Previous radiation to >25% of total bone marrow.
• Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation.
• Primary brain tumors or active brain metastases.
• Use of any investigational agents within 4 weeks.
• Treatment with chronic immunosuppressants.
• Uncontrolled, intercurrent illness.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Premiere Oncology

Santa Monica, California, United States

US Oncology Dayton Oncology and Hematology, P.A

Kettering, Ohio, United States

Countries

United States

References

Goldman JW, Raju RN, Gordon GA, El-Hariry I, Teofilivici F, Vukovic VM, Bradley R, Karol MD, Chen Y, Guo W, Inoue T, Rosen LS. A first in human, safety, pharmacokinetics, and clinical activity phase I study of once weekly administration of the Hsp90 inhibitor ganetespib (STA-9090) in patients with solid malignancies. BMC Cancer. 2013 Mar 25;13:152. doi: 10.1186/1471-2407-13-152.

Reference Type: DERIVED

PMID: 23530663 (View on PubMed)

Other Identifiers

9090-02

Identifier Type: -

Identifier Source: secondary_id

9090-02

Identifier Type: -

Identifier Source: org_study_id