Study of CKD-215 and D215 in Adults With BRCA-mutated Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CKD-215, D215.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: 19 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Drug CKD-215
2 tablets BID at 12-hour intervals for 7 days - Drug D215
2 tablets BID at 12-hour intervals for 7 days
Primary outcome measures
- AUCtau [Time frame: 0~12 hours]
- Css,max [Time frame: 0~12 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07532148 · A163_01BE2510