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

S

Synta Pharmaceuticals

Status and phase

Unknown
Phase 1

Conditions

Solid Tumors

Treatments

Drug: STA 9090 (ganetespib)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00688116
9090-01

Details and patient eligibility

About

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

Full description

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.

Enrollment

45 estimated patients

Sex

All

Ages

25+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

45 participants in 1 patient group

ganetespib
Experimental group
Treatment:
Drug: STA 9090 (ganetespib)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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