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A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

A Pharmacokinetic and Safety Assessment of G3139 Administered by Subcutaneous Injection to Patients With Solid Tumors


Inclusion Criteria:



- A Confirmed diagnosis of a solid tumor malignancy, not to include lymphoma, that has
failed standard therapy or for which no standard therapy is available. Patients with
a history of brain metastasis will be eligible if there is no evidence of cerebral
edema or treatment with steroids.

- Adequate organ function as determined < 7 days prior to starting study medication

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

- At least 3 weeks and recovery from effects of major prior surgery or other therapy
including radiation therapy, immunotherapy, cytokine, biological, vaccine and
chemotherapy

Exclusion Criteria:

- Significant medical diesese

- History of leptomeningeal disease

- Coexisting condition that would require the subject to continue therapy during the
treatment phase of the study with a drug known to alter renal function.

- Use of any investigational drug within 3 weeks prior to starting study medication

- Known hypersensitivity to phosphorothioate-containing oligonucleotides

- Pregnancy/Lactation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

GPKS106

NCT ID:

NCT00543231

Start Date:

December 2005

Completion Date:

December 2006

Related Keywords:

  • Tumors
  • ECOG
  • MRT
  • NCI CTC
  • SAE
  • Short Intravenous Infusion to Patients with Solid Tumors

Name

Location

Clinical Research Institute for Drug Development San Antonio, Texas  78229