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An Open-Label, Phase I/II, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Cancers

Thank you

Trial Information

An Open-Label, Phase I/II, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0032

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

PMT4979g

NCT ID:

NCT01296555

Start Date:

March 2011

Completion Date:

October 2014

Related Keywords:

  • Solid Cancers
  • Breast Neoplasms

Name

Location

Phoenix, Arizona  85012
Miami, Florida  33176
Albany, New York  12208
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Boston, Massachusetts  
Tulsa, Oklahoma