Study of a new medicine called “GDC-0927” in women who have a certain kind of

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

Breast Cancer

Basic Details

Gender

Female

Age

≥18 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT02316509, GO29656, 2015-000272-95

This clinical trial was done to study a new medicine called, “GDC-0927”. Researchers wanted to find out what the highest dose of GDC-0927 was that was safe for patients with ER+/HER− breast cancer. Researchers also wanted to investigate GDC-0927 doses in order to be able to recommend a safe dose that could be used in future studies. Forty-two patients took part in this study at 14 study centers in 2 countries.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Trial Identifier NCT02316509, GO29656, 2015-000272-95

Condition Breast Cancer

Official Title An Open-Label, Phase I Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Study 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.

Eligibility Criteria

Gender

Female

Age

≥18 Years

Healthy Volunteers

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

Study of a new medicine called “GDC-0927” in women who have a certain kind of

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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Study of a new medicine called “GDC-0927” in women who have a certain kind of breast cancer

Basic Details

What you can do next

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What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

Study of a new medicine called “GDC-0927” in women who have a certain kind of