Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 43 of 601 for:    Recruiting, Not yet recruiting, Available Studies | Ovarian cancer

Study of IMP4297 in Patients With BRCA1/2 Mutation 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: NCT04089189
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Impact Therapeutics, Inc.

Brief Summary:
A phase II, multi-center, open-label, single-arm, non-randomized study to evaluate the efficacy, safety and tolerability of IMP4297 capsules in subjects with germline and/or systemic BRCA1/2 mutated advanced ovarian cancer in china

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: IMP4297 Phase 2

Detailed Description:

A total of 100 subjects with germline and/or systemic BRCA1/2 mutated advanced ovarian cancer is planned to be enrolled to observe the efficacy, safety, tolerability and PK profile of IMP4297.

The primary objective is to assess ORR in subjects with germline and/or systemic BRCA1/2 mutated advanced ovarian cancer with at least 2 prior lines of standard systemic therapy treated with IMP4297 capsules by independent imaging according to RECIST v1.1. Subjects will be treated until there is evidence of disease progression or any other discontinuation criterion is met. Best supportive care will be provided to all subjects and will be decided by investigators if there are no other specific restrictions within the protocol.

Four to seven blood samples (approximately 2 mL/sample) are planned to be collected for each enrolled subject for the popPK and/or dose-response evaluation. Sample collection visits are planned on Cycle (C) 1 Day (D) 1, C1D15, C2D1, C3D1 and C4D1. The actual administration time, dose and blood collection time should be accurately recorded.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of IMP4297 Capsules in Subjects With Germline and/or Systemic BRCA1/2 Mutation Positive Advanced Ovarian Cancer With at Least 2 Prior Lines of Standard Systemic Therapy
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: IMP4297
100 subjects to receive IM4297 orally.
Drug: IMP4297
IMP4297 100mg PO QD




Primary Outcome Measures :
  1. ORR [ Time Frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months ]
    Disease response as determined by Overall Response Rate per RECIST Version 1.1


Secondary Outcome Measures :
  1. DOR [ Time Frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months ]
    Disease response as determined by Duration of Response per RECIST Version 1.1

  2. FPS [ Time Frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months ]
    Disease response as determined by Progression Free Survival per RECIST Version 1.1

  3. DCR [ Time Frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months ]
    Disease response as determined by Disease Control Rate per RECIST Version 1.1

  4. CBR [ Time Frame: From enroll until a new antitumor therapy, disease progression, subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months ]
    Disease response as determined by Clinical Benefit Rate per RECIST Version 1.1

  5. OS [ Time Frame: From enroll until subject's withdrawal of informed consent form (ICF) and/or death,whichever came first, assessed up to 24 months ]
    Disease response as determined by overall survival

  6. Incidence of Treatment-Emergent Adverse Events [ Time Frame: from the day of first enrolled of study drugs up to 30 days after the last administration ]
    Treatment-Emergent Adverse Events assessed by the investigator according to CTCAE 4.03



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   2) Female subjects ≥ 18 years of age with histologically or cytologically confirmed advanced non-mucinous ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects have to sign ICF prior to study-related procedures.
  2. Female subjects ≥ 18 years of age with histologically or cytologically confirmed advanced non-mucinous ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer;
  3. Germline and/or systemic BRCA1/2 mutation confirmed by central laboratory;
  4. Disease relapse or progression after no less than 2 prior lines of platinum-based chemotherapy
  5. No disease relapse or progression (based on clinical, CA125 or imaging) within 6 calendar months after the last platinum-containing regimen;
  6. At least one measurable lesion confirmed by independent central imaging according to the criteria of RECIST v1.1;
  7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1 (refer to Appendix 1);
  8. Expected survival time ≥ 12 weeks;
  9. Subjects, of sexually active and childbearing potential, and their spouses have to use contraception during the study and 90 days after the last dose of investigational drug (refer to Appendix 6 for acceptable contraception)

Exclusion Criteria:

  1. Inadequate hematopoiesis or organ function (corrective treatment with blood products ≤ 14 days prior to the first dose of investigational drug, e.g. transfusion, etc., is not allowed):

    Absolute neutrophil count (ANC) <1.5×109/L; Hemoglobin (HGB) <9 g/dL; Platelet (PLT) <100×109/L; Total bilirubin (TBIL) >1.5 × upper limit of normal (ULN); Aspartate transferase (AST) and/or alanine aminotransferase (ALT) >3×ULN, AST and/or ALT of subjects with liver metastases >5×ULN; Creatine (Cr) >1.5 × ULN; International normalized ratio (INR) >1.5×ULN, or activated Partial thromboplastin time (aPTT) >1.5×ULN, (INR only for subjects who have not received anticoagulant therapy);

  2. Have a history of radiation therapy < 4 weeks prior to the first dose of investigational drug, or chemotherapy, biological therapy, endocrine therapy or small molecule targeted therapy before the first dose of investigational drug (subject whose washout period ≥ 5 half-lives from the first dose of investigational drug can be enrolled);
  3. Have received strong CYP3A4 inhibitors or strong CYP3A4 inducers prior to the first dose of investigational drug (washout period from the first dose of investigational drug ≥ 5 half-lives is allowed) or require continued treatment with these drugs during the study (as described in Section 6.9.2 of the protocol; refer to Appendix 2 for common CYP3A4 strong inhibitors or CYP3A4 strong inducers)
  4. Have not recovered to NCI CTCAE v4.03 ≤ grade 1 from the toxicity of previous anti-tumor treatment, except alopecia;
  5. Have had treatment with drugs targeting poly-ADP-ribose polymerase (PARP);
  6. Clinically significant active infection;
  7. History of clinically significant liver disease, including active viral or other hepatitis, history of alcohol abuse or cirrhosis; except for subjects with previous viral hepatitis confirmed to be inactive by polymerase chain reaction (PCR) assay;
  8. Human immunodeficiency virus (HIV) infection;
  9. Have congestive heart failure graded classification II or above assessed by New York Heart Association (NYHA); history of myocardial infarction or unstable angina within 6 months before treatment; history of stroke or transient ischemic attack within 6 months before treatment;
  10. Subjects with active or untreated central nervous system metastases; subjects with treated brain metastases can be enrolled if the following criteria is met:

    Have no imaging progression ≥ 4 weeks after the end of treatment; The treatment completed ≥ 28 days prior to the first dose of investigational drug; Have no need to receive treatment with systemic corticosteroids (> 10 mg/day prednisone or equivalent) ≤ 14 days prior to the first dose of investigational drug;

  11. Pregnant or lactating women
  12. Subjects who had intestinal obstruction within 12 weeks prior to the first dose of investigational drug;
  13. History of other malignancy within 5 years prior to the first dose of investigational drug;
  14. Have had major surgery within 4 weeks prior to the first dose of investigational drug;
  15. Subjects, at the discretion of the investigator, with poor compliance or with any factors unsuitable for participation in this trial; subjects, at the discretion of the investigator, to be unsuitable for participation in this study due to any clinical or laboratory abnormality.

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): NCT04089189


Contacts
Layout table for location contacts
Contact: Calvin mei 86 68411181 ext 8615021115582 chongzi.mei@impacttherapeutics.com

Sponsors and Collaborators
Impact Therapeutics, Inc.

Layout table for additonal information
Responsible Party: Impact Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04089189     History of Changes
Other Study ID Numbers: IMP4297-2018-CN01
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma