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Clinical Trial VICCPHI1248

Title

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC0032 in Patients with Locally Advanced or Metastatic Solid Tumors and in Combination with Endocrine Therapy in Patients with Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Principal Investigator(s)

Ingrid Mayer

Details

  • Protocol No. VICCPHI1248
  • Open Date: 10/12/2012
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: - To evaluate the safety and tolerability of daily administration of GDC-0032 - To evaluate the safety and tolerability of concomitant daily administration of GDC-0032 and letrozole in postmenopausal female patients with locally advanced or metastatic hormone receptor-positive breast cancer - To evaluate the safety and tolerability of concomitant daily administration of GDC-0032 and fulvestrant in postmenopausal female
  • Disease Sites: Breast; Phase I
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Fulvestrant; GDC-0032; Letrozole (Femara); Midazolam
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01296555
  • Secondary Protocol No: PMT4979g

Description

Patients are asked to take part in this research study because they have an advanced stage cancer and one or more of the following conditions: There is no proven treatment for the patient's cancer The patient's cancer got worse while they were treated with standard treatment The patient had bad side effects when they were treated with standard treatment The purpose of this study is to test the safety of an investigational drug (GDC-0032) to find a safe and tolerated dose, how often it should be taken, how well patients with cancer can tolerate this investigational drug, and to measure how your body processes the study drug at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their cancer.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Histologically documented, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen and are not candidates for regimens known to provide clinical benefit
• Phase II: Post-menopausal female patients with locally advanced or metastatic hormone receptor-positive breast cancer
• Evaluable or measurable disease per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening
• Life expectancy of >= 12 weeks
• Adequate hematologic and organ function within 14 days prior to initiation of study treatment
• Documented willingness to use an effective means of contraception for both men and women while participating in the study
Exclusion Criteria:
• Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring treatment)
• Grade >=2 peripheral neuropathy
• Active congestive heart failure or ventricular arrhythmia requiring medication
• Patients requiring any daily supplemental oxygen
• Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
• Treatment with chemotherapy <= 3 weeks before study treatment
• Treatment with investigational drug <= 4 weeks before study treatment
• Treatment with biologic therapy <= 3 weeks before study treatment
• Treatment with kinase inhibitors <= 2 weeks before study treatment
• Radiation therapy (other than radiation to bony metastases) as cancer therapy <= 4 weeks before study treatment
• Palliative radiation therapy to bony metastases <= 2 weeks before study treatment
• Major surgery <= 4 weeks before study treatment
• Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications