Description:
This is an open-label, multicenter, dose-escalation study designed to assess the safety,
tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either
docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have
HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer
(NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal
growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There
are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and
a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm
has been established from dose escalation, additional patients with each combination will be
enrolled in Stage 2.
Title
- Brief Title: A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer
- Official Title:
Clinical Trial IDs
- ORG STUDY ID:
GO27802
- SECONDARY ID:
2013-003543-28
- NCT ID:
NCT01862081
Conditions
- Breast Cancer, Non-small Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Docetaxel | | Arm A: GDC-0032 + Docetaxel |
GDC-0032 | | Arm A: GDC-0032 + Docetaxel |
Paclitaxel | | Arm B: GDC-0032 + Paclitaxel |
Purpose
This is an open-label, multicenter, dose-escalation study designed to assess the safety,
tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either
docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have
HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer
(NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal
growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There
are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and
a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm
has been established from dose escalation, additional patients with each combination will be
enrolled in Stage 2.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: GDC-0032 + Docetaxel | Experimental | Participants will receive GDC-0032 once daily for 21 consecutive days (beginning from Day 1) in each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle. | |
Arm B: GDC-0032 + Paclitaxel | Experimental | Participants will receive GDC-0032 once daily for 28 consecutive days (beginning from Day 1) in each 28-day cycle along with Paclitaxel on Days 1, 8, 15 and 22 of each 28-day cycle. | |
Arm C: GDC-0032 + Docetaxel | Experimental | Participants will receive GDC-0032 once daily on Day 1 and Days 8-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle. | |
Arm D: GDC-0032 + Docetaxel | Experimental | Participants will receive GDC-0032 once daily on Days 2-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle. | |
Arm E: GDC-0032 + Docetaxel | Experimental | Participants will receive GDC-0032 once daily on Days 1-14 of each 21-day cycle along with Docetaxel on Day 1 of each 21-day cycle. | |
Arm F: GDC-0032 + Paclitaxel | Experimental | Participants will receive GDC-0032 once daily on a 5-days on, 2-days off schedule in each 28-day cycle along with Paclitaxel on Days 1, 8, 5 and 22 of each 28-day cycle. | |
Arm G: GDC-0032 + Paclitaxel | Experimental | Participants will receive GDC-0032 once daily on a 3-days on, 4-days off schedule in each 28-day cycle along with Paclitaxel on Days 1, 8, 5 and 22 of each 28-day cycle. | |
Eligibility Criteria
Inclusion Criteria:
- Age >=18 years
- For paclitaxel combination arms: histologically or cytologically documented
adenocarcinoma of the breast with locally recurrent or metastatic disease
- For docetaxel combination arms: histologically or cytologically documented
adenocarcinoma of the breast with locally recurrent or metastatic disease or
histologically documented advanced (Stage IV) or recurrent NSCLC
- For participants with breast cancer: HER2-negative disease as defined by local
clinical guidelines
- Participants with NSCLC to be treated with docetaxel need to have received at least
one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel
be considered appropriate treatment
- Evaluable or measurable disease per response evaluation criteria in solid tumors
(RECIST) v.1.1
- Life expectancy >=12 weeks
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1 at screening
- Adequate hematologic and end organ function
- Use of highly effective form of contraception
Exclusion Criteria:
- Prior anti-cancer therapy
- Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor
- Known significant hypersensitivity to any components of study treatment
- Grade >=2 peripheral neuropathy
- Type 1 or Type 2 diabetes
- Grade >=2 hypercholesterolemia or hypertriglyceridemia
- Congenital long QT syndrome
- Active congestive heart failure or ventricular arrhythmia
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety: Incidence of adverse events |
Time Frame: | Approximately 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Area under the curve from time 0 to the last measurable concentration (AUC0-last) |
Time Frame: | Up to 28 days |
Safety Issue: | |
Description: | |
Measure: | Time to maximum observed plasma concentration (Tmax) |
Time Frame: | Up to 28 days |
Safety Issue: | |
Description: | |
Measure: | Maximum observed plasma concentration (Cmax) |
Time Frame: | Up to 28 days |
Safety Issue: | |
Description: | |
Measure: | Minimum observed plasma concentration (Cmin) |
Time Frame: | Up to 28 days |
Safety Issue: | |
Description: | |
Measure: | Objective response according to RECIST v1.1 |
Time Frame: | Approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Duration of response according to RECIST v1.1 |
Time Frame: | Approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS) according to RECIST v1.1 |
Time Frame: | Approximately 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Genentech, Inc. |
Last Updated
November 28, 2017