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Clinical Trials

Date: 2017-09-27

Type of information: Recruitment of the first patient

phase: 1

Announcement: recruitment of the first patient

Company: Radius Health (USA - MA)

Product: RAD140

Action mechanism:

  • androgen receptor modulator. RAD140 is a nonsteroidal selective androgen receptor modulator (SARM). The androgen receptor is highly expressed in many ER-positive, ER-negative, and triple-negative receptor breast cancers. Emerging clinical data suggest that androgen receptor positivity is associated with favorable clinical outcome in breast cancer. RAD140 selectively targets the AR receptor and has shown significant preclinical activity in endocrine resistant models as a single agent and in combination with standard of care.The RAD140 mechanism of action is differentiated from both selective estrogen receptor modulators (SERMs) and selective estrogen receptor degraders (SERDs).

Disease: hormone receptor positive breast cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details:

  • The trial is a safety and dose-ranging study in approximately 40 patients with progressive metastatic or locally advanced or metastatic breast cancer. In Part A of the trial, postmenopausal women with metastatic hormone receptor positive breast cancer will receive escalating doses of RAD140 by oral administration over a period of 28 days. Primary safety outcomes include rate of dose-limiting toxicities, adverse events related to treatment, and tolerability as measured by dose interruptions or adjustments. In addition, pharmacokinetics, pharmacodynamics and tumor response will also be evaluated. (NCT03088527)

Latest news:

  • • On September 29, 2017, Radius Health announced  that the first patient has been enrolled in the company's Phase 1 study of RAD140 for the treatment of hormone receptor positive breast cancer. The clinical trial is designed to evaluate the safety and maximum tolerated dose of RAD140 in approximately 40 patients.

Is general: Yes