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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01862081
First received: May 22, 2013
Last updated: December 1, 2015
Last verified: December 2015

May 22, 2013
December 1, 2015
July 2013
January 2016   (final data collection date for primary outcome measure)
  • Safety: Incidence of adverse events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of dose limiting toxicities [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01862081 on ClinicalTrials.gov Archive Site
  • Area under the curve from time 0 to the last measurable concentration (AUC0-last) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma concentration (Tmax) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration (Cmin) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Objective response according to RECIST v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response according to RECIST v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) according to RECIST v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Area under the curve from time 0 to the last measurable concentration [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Time to maximum observed plasma concentration [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
  • Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Not Provided
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer, Non-small Lung Cancer
  • Drug: Docetaxel
    Participants will receive docetaxel 75 milligrams per meter-squared (mg/m^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
  • Drug: GDC-0032
    Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
  • Drug: Paclitaxel
    Participants will receive paclitaxel 80 mg/m^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
  • Experimental: Arm A: GDC-0032 + Docetaxel
    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.
    Interventions:
    • Drug: Docetaxel
    • Drug: GDC-0032
  • Experimental: Arm B: GDC-0032 + Paclitaxel
    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.
    Interventions:
    • Drug: GDC-0032
    • Drug: Paclitaxel
  • Experimental: Arm C: GDC-0032 + Docetaxel
    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.
    Interventions:
    • Drug: Docetaxel
    • Drug: GDC-0032
  • Experimental: Arm D: GDC-0032 + Docetaxel
    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.
    Interventions:
    • Drug: Docetaxel
    • Drug: GDC-0032
  • Experimental: Arm E: GDC-0032 + Docetaxel
    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.
    Interventions:
    • Drug: Docetaxel
    • Drug: GDC-0032
  • Experimental: Arm F: GDC-0032 + Paclitaxel
    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.
    Interventions:
    • Drug: GDC-0032
    • Drug: Paclitaxel
  • Experimental: Arm G: GDC-0032 + 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.
    Interventions:
    • Drug: GDC-0032
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
196
December 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Reference Study ID Number: GO27802 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Belgium,   Canada,   Spain
 
NCT01862081
GO27802, 2013-003543-28
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP