A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer

Last updated: December 14, 2016
Sponsor: Genentech, Inc.
Overall Status: Completed

Phase

1

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT00960960
GDC4629g
GO01304
2009-010781-38
  • Ages > 18
  • All Genders

Study Summary

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or intravenous (IV) paclitaxel with and without IV bevacizumab or IV trastuzumab in participants with locally recurrent or metastatic breast cancer. The study consists of three parts. Part 1 (pictilisib will be administered in 21+7 schedule along with paclitaxel and/or bevacizumab), Part 2 (pictilisib will be administered in 5+2 schedule along with paclitaxel and/or bevacizumab or trastuzumab) and Part 3 (pictilisib will be administered in combination with letrozole). Part 1 and Part 2 consists of two stages; a dose escalation stage and a cohort-expansion stage.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease

  • Adequate organ and bone marrow function as assessed by laboratory tests

  • Evaluable disease or disease measurable per RECIST

  • Agreement to use an effective form of contraception for the duration of the study

Exclusion

Exclusion Criteria:

  • History of malabsorption syndrome or other condition that would interfere with enteralabsorption

  • Any condition requiring full-dose anticoagulants, such as warfarin, heparin, orthrombolytic agents

  • Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, radiotherapy, orhormonal therapy) within 4 weeks or 5 half-lives (whichever is shorter) of the firstdose of study treatment

  • Uncontrolled current illness

  • Active small or large intestine inflammation (such as Crohn's disease or ulcerativecolitis)

  • Clinically significant history of liver disease, including cirrhosis, current alcoholabuse, or current known active infection with human immunodeficiency virus (HIV),hepatitis B virus, or hepatitis C virus

  • Known HIV infection

  • New York Heart Association (NYHA) Class II or greater congestive heart failure

  • Active ventricular arrhythmia requiring medication

  • Pregnancy, lactation, or breastfeeding

  • Known significant hypersensitivity to study drugs or excipients

  • History of arterial thromboembolic disease within 6 months of first study treatment

  • No more than two prior chemotherapy regimens for metastatic disease

Study Design

Total Participants: 71
Study Start date:
August 01, 2009
Estimated Completion Date:
December 31, 2015

Connect with a study center

  • Leuven, 3000
    Belgium

    Site Not Available

  • Milano, Lombardia 20133
    Italy

    Site Not Available

  • Peoria, Illinois 61615
    United States

    Site Not Available

  • Boston, Massachusetts 02115
    United States

    Site Not Available

  • Nashville, Tennessee 37232
    United States

    Site Not Available

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