Study of CKD-215 and D215 in Adults With BRCA-mutated Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT07532148 — Phase 1, Not yet recruiting, 24 participants, Chong Kun Dang Pharmaceutical

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A Multicenter, Randomized, Open-Label, 2-Period Crossover Study to Evaluate Pharmacokinetics, Safety, and Tolerability of CKD-215 and D215 in Adults With Advanced BRCA-Mutated Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Registry	NCT07532148
Status	Not yet recruiting
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	Chong Kun Dang Pharmaceutical (Industry)
Conditions	Ovarian Cancer
Interventions	CKD-215, D215 (Drug)
Dates	start 2026-06-01 (estimated), primary completion 2027-06-01 (estimated), completion 2027-08-01 (estimated), first posted 2026-04-15, last updated 2026-04-15

-Summary

Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215

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+Detailed description

A Multi-center, Randomized, Open-Label, Multiple-dose, Two-Stage, Two-treatment, Two-period, Crossover Study

+Arms and interventions

Arm	Type	Interventions	Description
Experimental group 1	Experimental	Drug: CKD-215; Drug: D215	Period 1: Test drug(CKD-215) Period 2: Reference drug(D215)
Experimental group 2	Experimental	Drug: CKD-215; Drug: D215	Period 1: Reference drug(D215) Period 2: Test drug(CKD-215)

CKD-215 (Drug), also known as TEST drug: 2 tablets BID at 12-hour intervals for 7 days
D215 (Drug), also known as Reference drug: 2 tablets BID at 12-hour intervals for 7 days

+Outcome measures

Primary outcomes

AUCtau [0~12 hours]: Area under the plasma concentration-time curve over the dosing interval at steady state
Css,max [0~12 hours]: Maximum observed plasma concentration at steady state

+Eligibility

Sex: Female, ages: 19 Years to 75 Years

Inclusion Criteria:

* Between 19 aged and 75 aged in patients with advanced BRCA-mutated high-grade epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
* 18.0kg/m2≤body mass index(BMI)≤28.0kg/m2

Exclusion Criteria:

* Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
* Patients with central nervous system metastases, unless clinically stable after treatment
* CTCAE Grade 3 or higher adverse events(e.g., anemia, neutropenia, dysgeusia, cough, leukopenia, thrombocytopenia) related to D215
* Subjects who are unable to participate in this clinical trial at the discretion of the investigator

+Investigators

Jeong-Yeol Park, Ph.D, Study chair, Asan Medical Center