CompletedPhase 2

Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer

China93 participantsStarted 2019-10-28

Plain-language 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 somatic BRCA1/2 mutated advanced ovarian cancer in china

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects have to sign ICF prior to study-related procedures.
✓. Female subjects ≥ 18 years of age with histologically or cytologically confirmed advanced non-mucinous ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer;
✓. Germline and/or somatic BRCA1/2 mutation confirmed by central laboratory;
✓. Disease relapse or progression after no less than 2 prior lines of platinum-based chemotherapy
✓. No disease relapse or progression (based on clinical, CA125 or imaging) within 6 calendar months after the last platinum-containing regimen;
✓. At least one measurable lesion confirmed by independent central imaging according to the criteria of RECIST v1.1;
✓. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1 (refer to Appendix 1);
✓. Expected survival time ≥ 12 weeks;

Exclusion criteria

✕. 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):
✕. 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);
✕. 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)
✕. Have not recovered to NCI CTCAE v4.03 ≤ grade 1 from the toxicity of previous anti-tumor treatment, except alopecia;
✕. Have had treatment with drugs targeting poly-ADP-ribose polymerase (PARP);
✕. Clinically significant active infection;
✕. 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;
✕. Human immunodeficiency virus (HIV) infection;

What they're measuring

ORR

Timeframe: 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

Trial details

NCT IDNCT04089189

SponsorImpact Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Ovarian Cancer trials