Clinical trial · Interventional
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
NCT07532148CI-TRIAL-00108373not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical Trial to evaluate the pharmacokinetic Characteristics, safety and Tolerability among CKD-215 and D215
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CKD-215 | Drug | — | UNRESOLVED |
| D215 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group 1
- description
- Period 1: Test drug(CKD-215) Period 2: Reference drug(D215)
- interventionNames
- Drug: CKD-215
- Drug: D215
- type
- EXPERIMENTAL
- label
- Experimental group 2
- description
- Period 1: Reference drug(D215) Period 2: Test drug(CKD-215)
- interventionNames
- Drug: CKD-215
- Drug: D215
Primary outcomes (2)
- measure
- AUCtau
- timeFrame
- 0~12 hours
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.