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A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945604
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple negative breast cancer

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: SHR-1210 + Apatinib +Fluzoparib Phase 1

Detailed Description:

Drug: SHR-1210 + Apatinib +Fluzoparib SHR-1210 will be administered as an intravenous infusion, Apatinib tablets will be given orally, Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.

Treatment group : PD-1 antibody SHR-1210 combination with aptinib and fluzoparib

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib,Open-labeled, Multi-center, Dose-exploring Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib and Fluzoparib in Subjects With Recurrent and Metastatic Triple Negative Breast Cancer
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : August 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SHR-1210 + Apatinib +Fluzoparib
SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity
Drug: SHR-1210 + Apatinib +Fluzoparib
SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.
Other Name: Treatment group : PD-1 antibody SHR-1210 combination with aptinib and fluzoparib




Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: First cycle (28 days) ]
    Dose Limiting Toxicity


Secondary Outcome Measures :
  1. Adverse Events and Serious Adverse Events [ Time Frame: from the first drug administration to within 90 days for the last SHR-1210 dose ]
    AEs and SAEs

  2. Overall Response Rate (ORR) [ Time Frame: up to 12 months (approx) from the start of treatment ]
  3. Duration of response (DoR) [ Time Frame: up to 12 months (approx) from the start of treatment ]
  4. Disease Control Rate [ Time Frame: up to 12 months (approx) from the start of treatment ]
    DCR

  5. Progression-Free-Survival [ Time Frame: up to 12 months (approx) from the start of treatment ]
    PFS

  6. 12-months overall survival rate [ Time Frame: From the start of treatment to 1 year ]
    12-months overall survival rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed the informed consent.
  • Female aged ≥18 years old.
  • Histologically diagnosed patients with recurrent and metastatic triple negative breast cancer.
  • No more than 2-line chemotherapy failed at the stage of recurrence and metastasis .
  • Patients who have been treated with platinum-based regimen at the stage of recurrence/metastasis need non-disease progression (non-pd)during treatment
  • At least one measuring lesion that comfirmed by RECIST v1.1 standard.
  • The patients can swallow pills.
  • Have a life expectancy of at least 12 weeks.
  • The functions of vital organs meet protocal requirements.

Exclusion Criteria:

  • Subjects had any history of active autoimmune disease .
  • Subjects had previously been treated with anti-PD-1 and PD-L1 antibodies, or was known to be allergic to antibody drugs, or had previously been treated with apatinib, or had previously been treated with PARP inhibitors.
  • Subjects have untreated central nervous system metastasis.
  • History of hypertension and antihypertensive medications are not well controlled.
  • Some clinical symptoms or diseases of the heart that are not well controlled.
  • History of immunodeficiency including HIV-positive.
  • Subjects had active infections.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945604


Contacts
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Contact: Zongfei Zongfei Dai, master 18616240775 zongfeidai@hrglobe.cn
Contact: Quanren Wang, PhD 18036618570 wangquanren@hrglobe.cn

Locations
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China, Beijing
Beijing Cancer Hosptial Recruiting
Beijing, Beijing, China, 100142
Contact: Huiping Li, MD       huipingli2012@hotmail.com   
Contact: MD         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Huiping Li, PhD Beijing Cancer Hosptial

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03945604    
Other Study ID Numbers: FZPL-Ib-105
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: June 2019

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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
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action