A 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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01296555
First received: February 14, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0032 administered every day o rally (PO) in patients with locally advanced or metastatic solid tumors. In Phas e II of the study, the efficacy and safety of the combination GDC-0032 and fulve strant will be evaluated in post-menopausal female patients with locally advance d or metastatic hormone receptor-positive breast cancer.


Condition Intervention Phase
Solid Cancers
Drug: GDC-0032
Drug: fulvestrant
Drug: letrozole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0032 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Incidence of dose-limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0032 [ Time Frame: Days 1-35 ] [ Designated as safety issue: No ]
  • Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0032 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Safety in combination with letrozole: incidence of adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Safety in combination with fulvestrant: Incidence of adverse events [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Phase II: Clinical benefit rate with the combination GDC-0032 + fulvestrant [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Phase II: Objective response rate with the combination GDC-0032 + fulvestrant [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best overall response for patients with measurable disease according to RECIST v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Duration of objective response for patients with measurable disease according to RECIST v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) for patients with measurable disease according to RECIST v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Phase II: Duration of response with the combination GDC-0032 + fulvestrant [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Phase II: Progression-free survival with the combination GDC-0032 + fulvestrant [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Phase II: Overall survival with the combination GDC-0032 + fulvestrant [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 332
Study Start Date: March 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination expansion cohorts Drug: GDC-0032
Oral repeating dose
Drug: fulvestrant
Repeating dose
Drug: letrozole
Repeating dose
Experimental: Phase II Drug: GDC-0032
Oral repeating dose
Drug: fulvestrant
Repeating dose
Experimental: Single-Agent Cohorts Drug: GDC-0032
Oral repeating dose

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296555

Contacts
Contact: Reference Study ID Number: PMT4979g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 27 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01296555     History of Changes
Other Study ID Numbers: PMT4979g, GO00886
Study First Received: February 14, 2011
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014