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Trial record 12 of 30 for:    parp inhibitor ovarian | Recruiting, Not yet recruiting, Available Studies

A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Jiangsu HengRui Medicine Co., Ltd.
Sponsor:
Collaborator:
Beijing Cancer Hospital
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03075462
First received: March 6, 2017
Last updated: March 23, 2017
Last verified: March 2017
  Purpose
Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Condition Intervention Phase
Ovarian Cancer Triple Negative Breast Cancer Drug: Fluzoparib Drug: Apatinib Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib in Patients With Recurrent Ovarian Cancer or Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • The type and incidence of adverse events [safety and tolerability] [ Time Frame: From screening up to 28 days after end of treatment ]
    Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v4.03


Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 24 months (approx) from the start of treatment ]
    [Complete response + Partial response (CR+PR)] based on RECIST 1.1

  • Disease Control Rate (DOR) [ Time Frame: 24 months (approx) from the start of treatment ]
    [Complete response + Partial response + Stable disease (CR+PR+SD)] based on RECIST 1.1

  • Time to Progression (TTP) [ Time Frame: From date of enrollment until the date of first objective progression or CA-125 progression (only for ovarian cancer patients), assessed up to 36 months ]
    The time from start of the treatment until radiographic disease progression or CA-125 progression specific for ovarian cancer patients

  • Overall Survival (OS) [ Time Frame: From Cycle 1, Day 1 until death or up to 48 months (approx) ]
    Time from start of fluzoparib treatment until death due to any cause

  • Cmax [ Time Frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment ]
    Maximum Plasma Concentration

  • T1/2 (Half-life) [ Time Frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment ]
    The time required for the plasma concentration of a drug to be reduced by 50%

  • Area under curve (AUC) [ Time Frame: Within the first 5 weeks from start of fluzoparib treatment ]
    Area under the plasma concentration-time curve

  • V/F [ Time Frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment ]
    Volume of distribution

  • CL/F [ Time Frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment ]
    Plasma Clearance


Estimated Enrollment: 76
Actual Study Start Date: March 9, 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluzoparib + Apatinib
Fluzoparib and apatinib will be separately administered to patients on the 1st and 4th day, respectively. Then from the 7th day they are administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity.
Drug: Fluzoparib
Fluzoparib either at 40,60,80mg twice daily,capsule oral.
Other Names:
  • SHR3162
  • HS10160
Drug: Apatinib
Apatinib at 250mg once daily, tablet oral

  Eligibility

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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Life expectancy of more than 12 weeks.
  • Histologically or cytologically confirmed high-grade papillary-serous epithelial ovarian cancer,primary peritoneal, or fallopian tube cancers; subjects with a known deleterious breast cancer gene (BRCA) mutation and any other high-grade histology are also eligible. Subjects should have platinum-sensitive disease, where platinum-sensitive disease is defined as having had a > 6 month interval since last receiving platinum therapy prior to disease recurrence. Additionally, subjects with histologically or cytologically confirmed triple negative breast cancer (TNBC), that is locally advanced or metastatic, are also eligible.
  • Prior therapy:subjects with ovarian cancer,primary peritoneal, or fallopian tube cancers have received only 2 lines of platinum-based chemotherapies, and TNBC patients have received only 1 line of standard chemotherapy. Each prior chemotherapy must be given for at least 2 cycles.
  • At least one measurable lesion that can be accurately assessed by imaging (CT/MRI) at baseline
  • Subjects who have overall good overall general condition.
  • Signed informed consent.

Exclusion Criteria:

  • Subjects who received any previous treatment with any PARP inhibitors.
  • Subjects who received any previous treatment with any VEGFR inhibitors.
  • Less than 4 weeks from the last clinical trial.
  • Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
  • Unstable or uncontrolled hypertension.
  • Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
  • Subjects with brain metastases.
  • Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  • Subjects with a known hypersensitivity to fluzoparib, apatinib or any of the excipients of the products.
  • Ongoing infection (determined by investigator).
  • History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  • Pregnant or breast-feeding women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03075462

Contacts
Contact: Huiping Li, MD huipingli2012@hotmail.com
Contact: Yunong Gao, MD gaoyunong@vip.sina.com

Locations
China, Beijing
Beijing Cancer Hosptial Recruiting
Beijing, Beijing, China, 100142
Contact: Huiping Li, MD       huipingli2012@hotmail.com   
Contact: Yunong Gao, MD       gaoyunong@vip.sina.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Beijing Cancer Hospital
  More Information

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03075462     History of Changes
Other Study ID Numbers: FZPL-I-104-OC/BC
Study First Received: March 6, 2017
Last Updated: March 23, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
PARP inhibitor
VEGFR inhibitor
Combination therapy
Ovarian Cancer
Triple Negative Breast Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Ovarian Diseases
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on June 23, 2017