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NCT Number: NCT07532148

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

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

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-215

Drug

2 tablets BID at 12-hour intervals for 7 days

Other names: TEST drug

D215

Drug

2 tablets BID at 12-hour intervals for 7 days

Other names: Reference drug

Primary outcomes

  1. AUCtau

    Time frame: 0~12 hours

    Area under the plasma concentration-time curve over the dosing interval at steady state

  2. Css,max

    Time frame: 0~12 hours

    Maximum observed plasma concentration at steady state

Study contacts

Contact information is provided by the study sponsor or research team.

Jeong-Yeol Park, Ph.D

CONTACT

[email protected]

82-2-3010-3646

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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