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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003543-28 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Participants will receive docetaxel 75 milligrams per meter-squared (mg/m^2) intravenous (IV) dose on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | Approximately 3 years | |
| Safety: Incidence of dose limiting toxicities | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time 0 to the last measurable concentration (AUC0-last) | Up to 28 days | |
| Time to maximum observed plasma concentration (Tmax) | Up to 28 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists - Tampa (Dr. MLK Blvd) | Tampa | Florida | 33607 | United States | ||
| Massachusetts General Hospital |
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| 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. |
|
| GDC-0032 | Drug | Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets. |
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| Paclitaxel | Drug | Participants will receive paclitaxel 80 mg/m^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle. |
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| Maximum observed plasma concentration (Cmax) |
| Up to 28 days |
| Minimum observed plasma concentration (Cmin) | Up to 28 days |
| Objective response according to RECIST v1.1 | Approximately 3 years |
| Duration of response according to RECIST v1.1 | Approximately 3 years |
| Progression-free survival (PFS) according to RECIST v1.1 | Approximately 3 years |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Texas Oncology, P.A; Baylor Sammons Cancer Center | Dallas | Texas | 75231 | United States |
| Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | United States |
| UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy | Leuven | 3000 | Belgium |
| Princess Margaret Hospital | Toronto | Ontario | M4X 1K9 | Canada |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C582924 | 2-(3-(2-(1-isopropyl-3-methyl-1H-1,2-4-triazol-5-yl)-5,6-dihydrobenzo(f)imidazo(1,2-d)(1,4)oxazepin-9-yl)-1H-pyrazol-1-yl)-2-methylpropanamide |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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