Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Conditions
Brief summary
Occurrence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs)., The safety endpoint parameters are frequency and severity of AEs, vital signs, electrocardiography (ECG), and the results of laboratory safety tests and urinalysis., RPIID of KAND567 in combination with carboplatin therapy will be determined based on safety and tolerability (Part 1/Phase Ib only).
Detailed description
ORR at Weeks 12 and 18, according to RECIST 1.1 and GCIG definitions, i.e., best overall response in subjects with measurable disease, or without measurable disease evaluable by CA 125., Progression-free survival (PFS) at Weeks 12 and 18., Overall survival (OS) at end of study., Disease control rate (DCR) (Complete response [CR] + Partial response [PR] + Stable disease [SD]) at Weeks 12 and 18., Duration of response according to RECIST 1.1 and GCIG definitions (time from documentation of tumor response to disease progression)., KAND567 PK drug concentration data will be graphically visualized together with normalized PK drug concentration data from the previous KAN0001 study (i.e., no formal PK analysis will be performed)., Change in pain score, as measured by the Numeric Rating Scale (NRS) from baseline (Week 1) to Weeks 4, 7, 10, 13, 16 and 20.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs)., The safety endpoint parameters are frequency and severity of AEs, vital signs, electrocardiography (ECG), and the results of laboratory safety tests and urinalysis., RPIID of KAND567 in combination with carboplatin therapy will be determined based on safety and tolerability (Part 1/Phase Ib only). | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR at Weeks 12 and 18, according to RECIST 1.1 and GCIG definitions, i.e., best overall response in subjects with measurable disease, or without measurable disease evaluable by CA 125., Progression-free survival (PFS) at Weeks 12 and 18., Overall survival (OS) at end of study., Disease control rate (DCR) (Complete response [CR] + Partial response [PR] + Stable disease [SD]) at Weeks 12 and 18., Duration of response according to RECIST 1.1 and GCIG definitions (time from documentation of tumor response to disease progression)., KAND567 PK drug concentration data will be graphically visualized together with normalized PK drug concentration data from the previous KAN0001 study (i.e., no formal PK analysis will be performed)., Change in pain score, as measured by the Numeric Rating Scale (NRS) from baseline (Week 1) to Weeks 4, 7, 10, 13, 16 and 20. | — |
Countries
Denmark, Norway, Sweden