Study of the Safety and Pharmacology of GDC-0980 in Combination With Paclitaxel With or Without Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer

NCT01254526 | Completed Phase 1

• 2 other identifiers: PIM4880gGO00882
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 3

Brief Summary

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with taxane-based chemotherapy regimens utilized in patients with locally recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence and nature of dose-limiting toxicities (DLTs)

  Through Day 22

• Incidence, nature, and severity of adverse events

  Through study completion, up to 1 year, or early discontinuation

Secondary Outcomes (4)

• Pharmacokinetic parameters of GDC-0980, paclitaxel and bevacizumab (including total exposure, maximum and minimum plasma concentration, time to maximum observed plasma concentration, plasma half-life)

  Through Day 22

• Duration of response

  Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation

• Progression-free survival (PFS)

  Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation

• Objective tumor response

  Assessed at periodic intervals until study completion, up to 1 year, or early discontinuation

Study Arms (2)

A

EXPERIMENTAL

Drug: GDC-0980; Drug: paclitaxel

B

EXPERIMENTAL

Drug: GDC-0980; Drug: bevacizumab; Drug: paclitaxel

Interventions

GDC-0980 DRUG

Oral repeating dose

A; B

bevacizumab DRUG

Intravenous repeating dose

B

paclitaxel DRUG

Intravenous repeating dose

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally recurrent or metastatic breast cancer, not amenable to resection with curative intent
• For Arm C: Overexpression of HER2
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Adequate hematologic and organ function
• Evaluable or measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors)
• Female patients of childbearing potential must use an acceptable method of contraception to prevent pregnancy and to continue its use for the duration of the study

You may not qualify if:

• Prior anti-cancer therapy of more than two regimens of systemic cytotoxic chemotherapy for advanced or metastatic breast cancer
• Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
• History of Type 1 or Type 2 diabetes requiring regular medication
• History of clinically significant cardiac or pulmonary dysfunction
• History of malabsorption syndrome or other condition that would interfere with enteral absorption
• Any condition requiring full-dose anticoagulants
• Leptomeningeal disease as a manifestation of cancer
• Active infection requiring IV antibiotics
• Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs, inhaled steroids, or the equivalent of \<= 10 mg/day of prednisone
• Known clinically significant history of liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
• Known HIV infection
• Known untreated or active CNS metastases
• Pregnancy, lactation, or breastfeeding
• Major surgical procedure, open biopsy, or significant traumatic injury within a within a specified timeframe of the first dose of study treatment
• For Arm B:

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (3)

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

1-(4-((2-(2-aminopyrimidin-5-yl)-7-methyl-4-morpholinothieno(3,2-d)pyrimidin-6-yl)methyl)piperazin-1-yl)-2-hydroxypropan-1-one; Bevacizumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jennifer Lauchle, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 6, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: April 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

BE (1); US (2)