ClinicalTrials.gg
Not yet recruitingNCT07532148Updated Apr 15, 2026

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

A Phase 1 interventional study of CKD-215 and D215 in Ovarian Cancer, sponsored by Chong Kun Dang Pharmaceutical. Not yet recruiting. Open to female participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
Female
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Ovarian Cancer

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03

In context

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

This study's planned enrollment of 24 is below the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 299 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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≤(BMI)≤28.0kg/m2

Exclusion criteria

Exclusion Criteria:

  • Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery
  • Patients with central nervous system , unless clinically stable after treatment
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Experimental group 1

    Period 1: Test drug(CKD-215) Period 2: Reference drug(D215)

    Drug: CKD-215 · Drug: D215

  • Experimental
    Experimental group 2

    Period 1: Reference drug(D215) Period 2: Test drug(CKD-215)

    Drug: CKD-215 · Drug: D215

Interventions

  • DrugCKD-215

    2 tablets BID at 12-hour intervals for 7 days

    Also known as: TEST drug

  • DrugD215

    2 tablets BID at 12-hour intervals for 7 days

    Also known as: Reference drug

06

What researchers measure

Primary outcomes

  1. AUCtau

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

    Time frame: 0~12 hours

  2. Css,max

    Maximum observed plasma concentration at steady state

    Time frame: 0~12 hours

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.

Of 210 industry-sponsored phase 1 interventional studies under Ovarian Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 65. This study's planned 12 months is below that.

Counting every sponsor, half of 380 studies reached it within 50 months; a quarter within 32 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2026
First posted
Apr 15, 2026
StartEst.
Jun 2026
Primary completionEst.
Jun 2027
CompletionEst.
Aug 2027
Last update
Apr 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07532148
Responsible party
Sponsor
First posted
Apr 15, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Apr 15, 2026

Study contacts

Jeong-Yeol Park, Ph.D
Contact
catgut1-0@hanmail.net
82-2-3010-3646
Jeong-Yeol Park, Ph.D
study chair · Asan Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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