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

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07532148
Enrollment
24
Registered
2026-04-15
Start date
2026-06-01
Completion date
2027-08-01
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Brief summary

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

Detailed description

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

Interventions

DRUGCKD-215

2 tablets BID at 12-hour intervals for 7 days

DRUGD215

2 tablets BID at 12-hour intervals for 7 days

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AUCtau0~12 hoursArea under the plasma concentration-time curve over the dosing interval at steady state
Css,max0~12 hoursMaximum observed plasma concentration at steady state

Contacts

CONTACTJeong-Yeol Park, Ph.D
catgut1-0@hanmail.net82-2-3010-3646
STUDY_CHAIRJeong-Yeol Park, Ph.D

Asan Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026