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OpenTrials
Completed

NCT Number: NCT01862081

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 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 information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

GDC-0032

Drug

Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.

paclitaxel

Drug

Participants will receive paclitaxel 80 mg/m^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: Approximately 3 years

  2. Safety: Incidence of dose limiting toxicities

    Time frame: Up to 28 days

Secondary outcomes

  1. Area under the curve from time 0 to the last measurable concentration (AUC0-last)

    Time frame: Up to 28 days

  2. Time to maximum observed plasma concentration (Tmax)

    Time frame: Up to 28 days

  3. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 28 days

  4. Minimum observed plasma concentration (Cmin)

    Time frame: Up to 28 days

  5. Objective response according to RECIST v1.1

    Time frame: Approximately 3 years

  6. Duration of response according to RECIST v1.1

    Time frame: Approximately 3 years

  7. Progression-free survival (PFS) according to RECIST v1.1

    Time frame: Approximately 3 years

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 24, 2013
Registry last updated
Nov 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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