A non-blinded Phase I/II study that evaluates the safety and tolerability of increasing doses of the study drug GDC-0032 administered to patients for the treatment of advanced cancers and in combination with endocrine therapy for the treatment of hormone receptor-positive breast cancer

Phase 1

• Conditions: 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; MedDRA version: 17.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002042-21-FR
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 392

Inclusion Criteria

•Phase I: 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 HER2-negative, 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 haematologic 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 212
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

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
• Oral endocrine therapy <= 2 weeks prior initiation of study treatment.
• For patients in Phase II and in Stage 2, Cohorts, J, K, L and M: prior treatment with fulvestrant
• For patients in Stage 2, Cohorts, J, K, L, M, N and P and patients in phase II: Prior treatment with > 1 cytotoxic chemotherapy regimen in the metastatic setting. (Prior treatment with everolimus is permitted and is not considered a cytotoxic chemotherapy.)
• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified