Study of CKD-215 and D215 in Adults With BRCA-mutated Adv... | NCT07532148

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

NCT07532148

Sponsor

Chong Kun Dang Pharmaceutical

Status

Not yet recruiting

Last Update Posted

Apr 15, 2026Actual

Enrollment

24Estimated

Phase

Phase 1

Conditions

Ovarian Cancer

Interventions

CKD-215
D215

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Jun 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Apr 9, 2026

First Submission Date that Met QC Criteria

Apr 9, 2026

First Posted Date

Apr 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group 1	Experimental	Period 1: Test drug(CKD-215) Period 2: Reference drug(D215)	Drug: CKD-215 Drug: D215
Experimental group 2	Experimental	Period 1: Reference drug(D215) Period 2: Test drug(CKD-215)	Drug: CKD-215 Drug: D215

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CKD-215	Drug	2 tablets BID at 12-hour intervals for 7 days	Experimental group 1 Experimental group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCtau	Area under the plasma concentration-time curve over the dosing interval at steady state	0~12 hours
Css,max	Maximum observed plasma concentration at steady state	0~12 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

This study is limited to female participants because the target diseases (ovarian cancer, fallopian tube cancer, and primary peritoneal cancer) occur in women.

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jeong-Yeol Park, Ph.D	Contact	82-2-3010-3646		catgut1-0@hanmail.net

Overall Officials

Name	Affiliation	Role
Jeong-Yeol Park, Ph.D	Asan Medical Center	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004341	Drug Evaluation

Ancestor Terms

ID	Term
D000076722	Drug Development
D008919	Investigative Techniques
D005069	Evaluation Studies as Topic

Browse Leaves

Not provided

Browse Branches

Not provided