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.
Verified January 2013 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01296555
First received: February 14, 2011
Last updated: January 4, 2013
Last verified: January 2013
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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 orally (PO).
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Cancers |
Drug: GDC-0032 Drug: letrozole Drug: fulvestrant |
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, 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:
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 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 ]
| Estimated Enrollment: | 122 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single-Agent Cohorts |
Drug: GDC-0032
Oral repeating dose
|
| Experimental: Combination expansion cohorts |
Drug: GDC-0032
Oral repeating dose
Drug: letrozole
Repeating dose
Drug: fulvestrant
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/or are not candidates for regimens known to provide clinical benefit
- Evaluable or measurable disease per RECIST v1.1
- 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 untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >= 3 months prior to initiation of study treatment
- Type 1 or 2 diabetes requiring daily anti-hyperglycemic medication
- 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 <= 4 weeks before study treatment
- Treatment with investigational drug <= 4 weeks before study treatment
- Treatment with biologic therapy <= 4 weeks before study treatment
- Treatment with kinase inhibitors <= 2 weeks before study treatment
- Radiation therapy <= 4 weeks before study treatment
- Radiation therapy for bony metastases <= 2 weeks before study treatment; other radiation for cancer therapy <= 4 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296555
Contacts
| Contact: Please reference Study ID Number: PMT4979g www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, Arizona | |
| Recruiting | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, Florida | |
| Recruiting | |
| Sarasota, Florida, United States, 34232 | |
| United States, Massachusetts | |
| Recruiting | |
| Boston, Massachusetts, United States, 02115 | |
| Recruiting | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Oklahoma | |
| Recruiting | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Tennessee | |
| Recruiting | |
| Nashville, Tennessee, United States, 37203 | |
| Recruiting | |
| Nashville, Tennessee, United States, 37232 | |
| Recruiting | |
| Nashville, Tennessee, United States, 37204 | |
| Spain | |
| Recruiting | |
| Barcelona, Spain, 08035 | |
| Recruiting | |
| Valencia, Spain, 46010 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Clinical Trials | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT01296555 History of Changes |
| Other Study ID Numbers: | PMT4979g, GO00886 |
| Study First Received: | February 14, 2011 |
| Last Updated: | January 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Letrozole Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013