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Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian 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. 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: NCT04556539
Recruitment Status : Not yet recruiting
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Brief Summary:
A phase II, multicenter, open-label, single-arm study to evaluate the efficacy, safety and pharmacokinetics of SC10914 in subjects with gBRCA1/2 mutated advanced ovarian cancer in china.

Condition or disease Intervention/treatment Phase
Advanced Ovarian Cancer Drug: SC10914 Phase 2

Detailed Description:

A total of 104 subjects with gBRCA1/2 mutated advanced ovarian cancer is planned to be enrolled to observe the efficacy, safety and PK profile of SC10914.

The subjects oral administration SC10914 tablets 400mg on an empty stomach, three times a day, for 28 consecutive days as a treatment cycle, until disease progression (PD) or the toxicity was intolerable. PK blood samples are planned to be collected for each enrolled subject on C1D28 visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SC10914 Monotherapy for gBRCA1/2 Mutation Advanced Ovarian Cancer Patients With at Least 2 Prior Lines of Chemotherapy: a Single Arm, Open Label, Multicenter Clinical Trial
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: SC10914 group Drug: SC10914
400mg TID, oral admination on fasting condition




Primary Outcome Measures :
  1. objective response rate (ORR) [ Time Frame: up to 100 weeks (estimated) ]
    assessed by the independent imaging assessment committee (recist1.1)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign informed consent voluntarily;
  2. ≥18 years old;
  3. Histologically confirmed ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer( high-grade carcinoma cancer or endometrioid carcinoma);
  4. gBRCA1/2 mutation positive;
  5. Had recived at least 2 prior lines of chemotherapy;
  6. Platinum sensitive patients;
  7. The last line of therapy befor enrollment failed;
  8. ECOG≤2;

8. Had at least one measurable lesion.

Exclusion Criteria:

  1. Any previous treatment with PARP inhibitor;
  2. Symptomatic brain metastases;
  3. Large amount of fluid in the third gap;
  4. Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria: ANC<1.5×10^9/L PLT<100×10^9/L Hb<100g/L TBIL>1.5×ULN ALT, AST>2.5×ULN (without liver metastases) or ALT, AST>5×ULN (with liver metastases) Cr >1.5×ULN

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): NCT04556539


Contacts
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Contact: Liu chunlei 13911737489 liuchunlei@sh-qingfeng.net
Contact: Zhang zhe 13115039707 zhangzhe@sh-qingfeng.net

Sponsors and Collaborators
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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Responsible Party: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT04556539    
Other Study ID Numbers: QF-SC10914-201
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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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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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type