A Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/13/2019 |
Start Date: | November 9, 2015 |
End Date: | November 30, 2019 |
An Open-Label, Phase I Study of GDC-0927 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
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.
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.
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
We found this trial at
7
sites
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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199-203 Avinguda de la Granvia
L'Hospitalet de Llobregat, Barcelona 08908
L'Hospitalet de Llobregat, Barcelona 08908
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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