EUCTR2016-003074-40-ES
Active, not recruiting
Phase 1
A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer.
ConditionsER-positive Breast CancerMedDRA version: 19.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsFaslodex
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ER-positive Breast Cancer
- Sponsor
- GlaxoSmithKline Research & Development Limited
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent provided
- •2\. Females 18 years old and greater (at the time of written consent)
- •3\. Histologically or cytologically confirmed diagnosis of advanced or metastatic adenocarcinoma of the breast.
- •4\. Documentation of ER\-positive and/or PR\-positive tumor based on local testing of the most recent tumor biopsy
- •5\. Documentation of HER2\-negative tumor based on local testing of the most recent tumor biopsy
- •6\. History of prior therapy that satisfies one of the following criteria:
- •a. AI failures: disease that progressed during treatment or within 12 months of completion of adjuvant therapy with tamoxifen and/or AI
- •b.CDK 4/6 inhibitor plus letrozole failures: disease that progressed during treatment or within 1 month after the end of treatment with prior tamoxifen, AI, or the combination of a CDK4/6 inhibitor plus letrozole, for advanced/metastatic disease
- •7\. Any menopausal status
- •8\. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1\.1 criteria
Exclusion Criteria
- •1\.Prior therapy with more than one line of cytotoxic chemotherapy following diagnosis of advanced/metastatic disease.
- •2\. Disease which has progressed despite prior fulvestrant therapy.
- •3\. \=3 lines of systemic anti\-cancer therapy (including 1 line of chemotherapy).
- •4\.Recent prior therapy, defined as:
- •· Any investigational or approved non\-biologic anti\-cancer drug within 14 days prior to the first dose of GSK525762 and fulvestrant.
- •· Any nitrosoureas or mitomycin C within 42 days prior to the first dose of GSK525762 and fulvestrant
- •· Any anti\-cancer biologic agents within 28 days prior to the first dose of GSK525762 and fulvestrant
- •· Any radiotherapy within 30 days prior to the first dose of GSK525762 and fulvestrant. If the subject received radiotherapy \<90 days prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.
- •· Any major surgery within 28 days prior to the first dose of GSK525762 and fulvestrant
- •5\.Concomitant active malignancy other than ER\+BC
Outcomes
Primary Outcomes
Not specified
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