Expired Study
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Waltham, Massachusetts 02451


Purpose:

The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of RAD1901 in patients with advanced ER+, HER2-negative breast cancer.


Study summary:

The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RAD1901 in patients with advanced ER+HER2-negative breast cancer. The secondary objectives of this study are: - To assess the safety and tolerability of RAD1901 - To evaluate the pharmacokinetics (PK) of RAD1901 - To evaluate the preliminary anti-tumor effect of RAD1901


Criteria:

Inclusion Criteria: 1. Patients must be post-menopausal women, as defined in the protocol 2. 18 years or older 3. Patients with histological or cytological proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced, inoperable and/or metastatic disease 4. Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy Exclusion Criteria: 1. Prior anticancer or investigational drug treatment within the following windows: 1. Tamoxifen therapy less than 14 days before first dose of study treatment 2. Fulvestrant therapy less than 90 days before first dose of study treatment 3. Any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment 4. Any chemotherapy less than 28 days before first dose of study 5. Any investigational drug therapy less than 28 days or 3 half-lives (whichever is longer) prior to first dose of study treatment 2. Patients with untreated or symptomatic central nervous system (CNS) metastases 3. Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts


NCT ID:

NCT02338349


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Waltham, Massachusetts 02451
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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