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SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03596658
Recruitment Status : Unknown
Verified July 2018 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
ER+ HER2- Advanced Breast Cancer Drug: SHR9549 Phase 1

Detailed Description:
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women with Estrogen Receptor (ER) Positive Human Epidermal Receptor (HER-2) Negative Advanced Breast Cancer

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women With ER Positive HER2 Negative Advanced Breast Cancer
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SHR9549 dose escalation and expansion(s)
Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients
Drug: SHR9549
If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined
Other Name: SHR9549 tablet




Primary Outcome Measures :
  1. Dose Limited Toxicity (DLT) [ Time Frame: baseline through 28 days ]
    to determine DLT in order to assess the tolerability of SHR9549

  2. Maximum Tolerated Dose (MTD) [ Time Frame: baseline through 28 days ]
    to determine MTD in order to assess the tolerability of SHR9549


Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: baseline through 12 weeks ]
    Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals

  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: baseline through 12 weeks ]
    Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals

  3. overall response rate (ORR) [ Time Frame: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months ]
    Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

  4. progression free survival (PFS) [ Time Frame: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months ]
    Antitumour activity evaluation by following up patients' progression and survival

  5. Incidence of Treatment-Emergent Adverse Events [ Time Frame: baseline through 30 days after study completion ]
    to assess the safety of SHR9549



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03596658    
Other Study ID Numbers: SHR9549-I-101
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases