A Phase 1 interventional study of Docetaxel and GDC-0032 in Breast Cancer, Non-small Lung Cancer, sponsored by Genentech, Inc.. Completed at 14 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-28.
Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 80 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Docetaxel · Drug: GDC-0032
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.
Drug: GDC-0032 · Drug: Paclitaxel
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.
Drug: Docetaxel · Drug: GDC-0032
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.
Drug: Docetaxel · Drug: GDC-0032
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.
Drug: Docetaxel · Drug: GDC-0032
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.
Drug: GDC-0032 · Drug: Paclitaxel
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.
Drug: GDC-0032 · Drug: Paclitaxel
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m\^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Participants will receive paclitaxel 80 mg/m\^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
Safety: Incidence of adverse events
Time frame: Approximately 3 years
Safety: Incidence of dose limiting toxicities
Time frame: Up to 28 days
Area under the curve from time 0 to the last measurable concentration (AUC0-last)
Time frame: Up to 28 days
Time to maximum observed plasma concentration (Tmax)
Time frame: Up to 28 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 28 days
Minimum observed plasma concentration (Cmin)
Time frame: Up to 28 days
Objective response according to RECIST v1.1
Time frame: Approximately 3 years
Duration of response according to RECIST v1.1
Time frame: Approximately 3 years
Progression-free survival (PFS) according to RECIST v1.1
Time frame: Approximately 3 years
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.