A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer

NCT02338349 | Completed Phase 1

• 1 other identifier: RAD1901-005
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced ER+, HER2-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities (DLT)

  To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of Elacestrant (RAD1901), the incidence of Dose Limiting toxicities (DLTs) will be assessed.

  The first 28 days of treatment.

Secondary Outcomes (3)

• Safety and Tolerability of Elacestrant (RAD1901)

  Up to 30 days after the end of treatment.

• Pharmacokinetics of Elacestrant (RAD1901)

  Every 28 days

• Anti-Tumor Effect of Elacestrant (RAD1901)

  Every 8 weeks

Study Arms (1)

Elacestrant

EXPERIMENTAL

Part A, Dose Escalation: Patients will be assigned sequentially to escalating doses of elacestrant. Part B, Safety Expansion: Once the MTD has been identified and/or a RP2D has been selected, additional patients will be enrolled to further evaluate the safety, tolerability and preliminary efficacy of the RP2D. Part C, Tablet Introduction: A cohort of patients will be enrolled to evaluate the safety, tolerability, and PK of a tablet dosage form at 400 mg QD. Part D, Dose Expansion: A cohort of patients will be enrolled to evaluate the safety, tolerability, PK and preliminary anti-tumor effect of elacestrant in tablet dosage form at 400 mg QD PO in a group of patients with a more homogeneous prior treatment history

Drug: Elacestrant

Interventions

Elacestrant DRUG

Elacestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be post-menopausal women, as defined in the protocol
• years or older
• Patients with histological or cytological proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced, inoperable and/or metastatic disease
• Part A, B, C: Patients must have received no more than 2 prior chemotherapeutic regimens and at least 6 months of prior endocrine therapy
• Part D: Patients may have received up to 1 previous line of chemotherapy and must have previously received 2 or more lines of endocrine therapy for advanced/metastatic breast cancer as a single agent or in combination. Patients must have received fulvestrant as one of the previous lines of endocrine therapy and have had documented progression while on, or within 1 month after the end of, fulvestrant therapy for advanced/metastatic breast cancer. Patients must have received prior treatment with a CDK4/6 inhibitor

You may not qualify if:

• Prior anticancer or investigational drug treatment within the following windows:
• Tamoxifen therapy less than 14 days before first dose of study treatment
• Part A, B and C: Fulvestrant therapy less than 90 days before first dose of study treatment. Part D: Fulvestrant therapy less than 42 days before first dose of study treatment
• Any other anti-cancer endocrine therapy less than 14 days before first dose of study treatment
• Any chemotherapy less than 28 days before first dose of study
• Any investigational drug therapy less than 28 days or 3 half-lives (whichever is longer) prior to first dose of study treatment
• Patients with untreated or symptomatic central nervous system (CNS) metastases
• Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts

Sponsors & Collaborators

• Stemline Therapeutics, Inc.: lead

Study Sites (1)

Radius Pharmaceuticals, Inc.

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

• Bardia A, Kaklamani V, Wilks S, Weise A, Richards D, Harb W, Osborne C, Wesolowski R, Karuturi M, Conkling P, Bagley RG, Wang Y, Conlan MG, Kabos P. Phase I Study of Elacestrant (RAD1901), a Novel Selective Estrogen Receptor Degrader, in ER-Positive, HER2-Negative Advanced Breast Cancer. J Clin Oncol. 2021 Apr 20;39(12):1360-1370. doi: 10.1200/JCO.20.02272. Epub 2021 Jan 29.

  PMID: 33513026 DERIVED

MeSH Terms

Interventions

elacestrant

Study Officials

• Sr. Director, Clinical Operations

  Radius Pharmaceticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 14, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: April 1, 2020
• Last Updated: August 18, 2022

Record last verified: 2020-05

Locations

US (1)