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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

February 14, 2011
October 6, 2014
March 2011
July 2017   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01296555 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Cancers
  • Drug: GDC-0032
    Oral repeating dose
  • Drug: fulvestrant
    Repeating dose
  • Drug: letrozole
    Repeating dose
  • Experimental: Combination expansion cohorts
    Interventions:
    • Drug: GDC-0032
    • Drug: fulvestrant
    • Drug: letrozole
  • Experimental: Phase II
    Interventions:
    • Drug: GDC-0032
    • Drug: fulvestrant
  • Experimental: Single-Agent Cohorts
    Intervention: Drug: GDC-0032
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
332
July 2017
July 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: PMT4979g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Spain,   Canada
 
NCT01296555
PMT4979g, GO00886
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP