We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02316509
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Seragon Pharmaceuticals
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: GDC-0927 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase I Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Actual Study Start Date : March 17, 2015
Actual Primary Completion Date : January 10, 2020
Actual Study Completion Date : January 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: GDC-0927
GDC-0927 will be administered as per schedule specified in the respective arm.
Other Name: RO7056119

Experimental: 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.
Drug: GDC-0927
GDC-0927 will be administered as per schedule specified in the respective arm.
Other Name: RO7056119




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD)/Recommended Phase II Dose (RP2D) of GDC-0927 [ Time Frame: Day-7 through Cycle 1 (cycle length: 28 days) ]
  2. Percentage of Participants With Adverse Events (AEs) [ Time Frame: From screening up to approximately 3 years ]

Secondary Outcome Measures :
  1. Percentage of Participants With Objective Response Assessed by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: At screening, every 8 weeks from Cycle 1 (each cycle: 28 days) up to end of treatment (up to approximately 3 years) ]
  2. Percentage of Participants With Clinical Benefit Assessed by RECIST v1.1 [ Time Frame: At screening, every 8 weeks from Cycle 1 (each cycle: 28 days) up to end of treatment (up to approximately 3 years) ]
  3. Part I: Maximum Observed Plasma Concentration (Cmax) of GDC-0927 [ Time Frame: Pre-dose (0 hour [hr]), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day -7; Days -5, -4, -3; pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (cycle length: 28 days) ]
  4. Part II: Cmax of GDC-0927 [ Time Frame: Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (each cycle: 28 days) ]
  5. Part I: Time to Reach Cmax (Tmax) of GDC-0927 [ Time Frame: Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day -7; Days -5, -4, -3; pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (cycle length: 28 days) ]
  6. Part II: Tmax of GDC-0927 [ Time Frame: Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (each cycle: 28 days) ]
  7. Part I: Area Under the Plasma Concentration Versus Time Curve (AUC) of GDC-0927 [ Time Frame: Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day -7; Days -5, -4, -3; pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (cycle length: 28 days) ]
  8. Part II: AUC of GDC-0927 [ Time Frame: Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day 1 Cycle 1; pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8 hrs post-dose on Day 1 Cycle 2 (each cycle: 28 days) ]
  9. Plasma Half-Life (t1/2) of GDC-0927 [ Time Frame: Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day -7; Days -5, -4, -3; pre-dose (0 hr) on Day 1 Cycle 1 (cycle length: 28 days) ]
  10. Part II: t1/2 of GDC-0927 [ Time Frame: Pre-dose (0 hr), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hrs post-dose on Day 1 Cycle 1 (each cycle: 28 days) ]
  11. Part I: Change From Baseline in Corrected QT (QTc) Interval Using Fridericia's Formula, as Assessed by Electrocardiogram (ECG) [ Time Frame: Screening (baseline); Days -7, -5, -4, -3; Cycle 2 Day 1; end of treatment (up to approximately 3 years) (each cycle = 28 days) ]
  12. Part II: Change From Baseline in QTc Interval Using Fridericia's Formula, as Assessed by ECG [ Time Frame: Screening (baseline); Cycle 1 Day 1; Cycle 2 Day 1; end of treatment (up to approximately 3 years) (each cycle = 28 days) ]
  13. Part I: Change From Baseline in RR Interval, as Assessed by ECG [ Time Frame: Screening (baseline); Days -7, -5, -4, -3; Cycle 2 Day 1; end of treatment (up to approximately 3 years) (each cycle = 28 days) ]
  14. Part II: Change From Baseline in RR Interval, as Assessed by ECG [ Time Frame: Screening (baseline); Cycle 1 Day 1; Cycle 2 Day 1; end of treatment (up to approximately 3 years) (each cycle = 28 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316509


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital.
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Sarah Cannon Cancer Center
Germantown, Tennessee, United States, 38138
Vanderbilt Ingram Cancer Ctr
Nashville, Tennessee, United States, 37232
Spain
ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Onkologikoa - Kutxaren Institutu Onkologikoa
San Sebastian, Guipuzcoa, Spain, 20014
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
MD Anderson Cancer Center Madrid - España; Servicio de Farmacia
Madrid, Spain, 28033
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28040
HM Sanchinarro - CIOCC
Madrid, Spain, 28050
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Genentech, Inc.
Seragon Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02316509    
Other Study ID Numbers: GO29656
2015-000272-95 ( EudraCT Number )
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases