SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer

NCT03596658 | Terminated Phase 1 DMC

• 1 other identifier: SHR9549-I-101
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.

Conditions

ER+ HER2- Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Dose Limited Toxicity (DLT)

  to determine DLT in order to assess the tolerability of SHR9549

  baseline through 28 days

• Maximum Tolerated Dose (MTD)

  to determine MTD in order to assess the tolerability of SHR9549

  baseline through 28 days

Secondary Outcomes (5)

• Peak Plasma Concentration (Cmax)

  baseline through 12 weeks

• Area under the plasma concentration versus time curve (AUC)

  baseline through 12 weeks

• overall response rate (ORR)

  every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months

• progression free survival (PFS)

  every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months

• Incidence of Treatment-Emergent Adverse Events

  baseline through 30 days after study completion

Study Arms (1)

SHR9549 dose escalation and expansion(s)

EXPERIMENTAL

Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients

Drug: SHR9549

Interventions

SHR9549 DRUG

If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined

Also known as: SHR9549 tablet

SHR9549 dose escalation and expansion(s)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years.
• Confirmation of ER positive; HER2 negative Advanced breast cancer
• Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.
• Receipt of ≤2 lines of prior chemotherapy for advanced disease.
• Any menopausal status.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and with minimum life expectancy of 12 weeks.

You may not qualify if:

• Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.
• Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.
• Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.
• uncontrolled central nervous system metastatic disease.
• Any evidence of severe or uncontrolled systemic diseases.
• Inadequate bone marrow reserve or organ function.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The 307th Hospital of Military Chinese People's Liberation Army

Beijing, Beijing Municipality, 100071, China

Location

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: June 25, 2018
• First Posted: July 24, 2018
• Study Start: July 25, 2018
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: September 1, 2022

Record last verified: 2018-07

Locations

CN (1)