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CompletedPhase 1NCT01862081
Official study 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

Study summary

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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDocetaxel and GDC-0032

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 28, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?Genentech, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Genentech, Inc.
Interventions being studied
Drug: Docetaxel; Drug: GDC-0032; Drug: Paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→Metastatic or stage IV→Recurrent or relapsed→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Florida Cancer Specialists - Tampa (Dr. MLK Blvd)Tampa, Florida
  • Massachusetts General HospitalBoston, Massachusetts
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
  • Sarah Cannon Research InstituteNashville, Tennessee
  • Vanderbilt University Medical CenterNashville, Tennessee
  • Texas Oncology, P.A; Baylor Sammons Cancer CenterDallas, Texas
  • Texas Oncology, P.A. - Fort WorthFort Worth, Texas
  • Virginia Oncology AssociatesNorfolk, Virginia
  • Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington
  • UZ Leuven; Maag, -darm en leverziekten/endoscopie - EndoscopyLeuven
  • Princess Margaret HospitalToronto, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 28, 2017. Always confirm current availability with the study team.

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