A Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

NCT ID: NCT02316509

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-17
• Study Completion Date: 2020-01-10

Brief Summary

This is an open-label, dose-finding, safety, pharmacokinetics (PK), and evidence-of-activity study of GDC-0927 in postmenopausal women with locally advanced or metastatic Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 (HER2) breast cancer. The study will be conducted in two parts: Dose escalation and Dose expansion. During dose escalation, GDC-0927 will be administered orally as a single dose on Day -7 for PK evaluation during the lead-in period. Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0927 using standard 3+3 design. During dose expansion, there will be no PK week lead-in period. All participants will be treated until disease progression, unacceptable toxicity, participant withdrawal of consent or study termination.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part I: Dose Escalation - GDC-0927

Participants will receive GDC-0927 orally as a single dose on Day -7. Continuous daily dosing will commence on Day 1. Depending on safety and tolerability, participants will be assigned sequentially to escalating doses of GDC-0927 with use of a standard 3 + 3 design. The starting dose will be 600 milligrams per day (mg/day), followed by dose escalation in 400 milligrams (mg) increments.

Group Type: EXPERIMENTAL

GDC-0927

Intervention Type: DRUG

GDC-0927 will be administered as per schedule specified in the respective arm.

Part II: Dose Expansion - GDC-0927

Participants in the expansion cohorts will receive GDC-0927 at MTD/RP2D starting from Day 1 of Cycle 1 (cycle length: 28 days) up to disease progression, unacceptable toxicity, participant withdrawal of consent or study termination.

Group Type: EXPERIMENTAL

GDC-0927

Intervention Type: DRUG

GDC-0927 will be administered as per schedule specified in the respective arm.

Interventions

GDC-0927

GDC-0927 will be administered as per schedule specified in the respective arm.

Intervention Type: DRUG

Other Intervention Names

RO7056119

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for ER+ breast cancer
• ER-positive tumor, HER2-negative breast cancer
• No prior treatment with GDC-0810 (allowed only during dose expansion stage)
• No more than 2 prior chemotherapies in the advanced or metastatic setting
• At least 2 months must have elapsed from the use of tamoxifen
• At least 6 months must have elapsed from the use of fulvestrant
• At least 2 weeks must have elapsed from the use of any other endocrine therapy
• At least 3 weeks must have elapsed from the use of any chemotherapy
• Females, 18 years of age or older
• Postmenopausal status as defined by the protocol
• Eastern Cooperative Oncology Group (ECOG) Performance status less than or equal to (</=) 2 (for dose-escalation part) and 0 or 1 (for dose-expansion part)
• Adequate organ function

Exclusion Criteria

• Untreated or symptomatic brain metastases
• Current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
• Any of the following within 12 months prior to enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of Grade greater than or equal to (>/=) 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, or cerebrovascular accident including transient ischemic attack
• Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
• Known Human Immunodeficiency Virus (HIV) infection
• Major surgery within 4 weeks prior to enrollment
• Radiation therapy within 2 weeks prior to enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seragon Pharmaceuticals

UNKNOWN

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Massachusetts General Hospital.

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Sarah Cannon Cancer Center

Germantown, Tennessee, United States

Vanderbilt Ingram Cancer Ctr

Nashville, Tennessee, United States

ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO

L'Hospitalet de Llobregat, Barcelona, Spain

Onkologikoa - Kutxaren Institutu Onkologikoa

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, , Spain

MD Anderson Cancer Center Madrid - España; Servicio de Farmacia

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

HM Sanchinarro - CIOCC

Madrid, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Countries

United States; Spain

Other Identifiers

2015-000272-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO29656

Identifier Type: -

Identifier Source: org_study_id