GO39374: GDC-0077 for PIK3CA-mutant solid tumours / breast cancer
Research type
Research Study
Full title
A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients with Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination with Endocrine and Targeted Therapies in Patients with Locally Advanced or Metastatic PIK3CA-Mutant Hormone-Receptor Positive Breast Cancer
IRAS ID
221267
Contact name
Peter Schmid
Contact email
Sponsor organisation
Genentech
Eudract number
2016-003022-17
Clinicaltrials.gov Identifier
IND number:, 130909
Duration of Study in the UK
3 years, 2 months, 3 days
Research summary
Phosphatidylinositol 3-kinase (PI3K) is a protein that can promote cancer cell growth. GDC-0077 is designed to block PI3K effects. In mice with PI3K (PIK3CA) mutant breast cancer, GDC-0077 slowed or stopped cancer growth. It is believed that GDC-0077 will work the same in humans.
This study aims to evaluate GDC-0077 alone in patients with locally advanced or metastatic (cancer that has spread) PIK3CA-mutant cancer or GDC-0077 given together with palbociclib and letrozole or with letrozole in postmenopausal women with locally advanced or metastatic PIK3CA-mutant, hormone receptor-positive (HR+) breast cancer.
This is the first time GDC-0077 will be given to humans. It is an open-label study with 2 stages:
Stage 1 (approximately 57-96 patients) - GDC-0077 will be tested at different dose levels as follows:
Patients with locally advanced or metastatic PIK3CA-mutant cancer:
• Arm A: GDC-0077
Postmenopausal women with locally advanced or metastatic PIK3CA-mutant HR+ breast cancer:
• Arm B: GDC-0077 in combination with palbociclib and letrozole
• Arm C: GDC-0077 in combination with letrozole
Stage 2 (approximately 60 postmenopausal women with locally advanced or metastatic PIK3CA-mutant HR+ breast cancer)
• Arm B: GDC-0077 dose tolerable in Stage 1 Arm B in combination with palbociclib and letrozole
• Arm C: GDC-0077 dose tolerable in Stage 1 Arm C in combination with letrozole
• Arm D: GDC-0077 dose tolerable in Stage 1 Arm C in combination with fulvestrant
GDC-0077 is taken as a tablet every day for 28 day cycles. There are up to 7 visits in Cycle 1; the frequency of visits decreases in later cycles. Study procedures include physical examination, ECG, blood sampling, biopsy and imagining scans. Patients will continue in the study as long as they tolerate study treatment(s) and their cancer does not get worse
The study is sponsored by Genentech. Approximately 30 patients in the UK will participate from 2 sites.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/0163
Date of REC Opinion
9 Mar 2017
REC opinion
Further Information Favourable Opinion