A Study to Evaluate the Safety of KAND567, in Combination With Carboplatin Therapy, in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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Lead
Novakand Pharma AB
With
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Histologically verified high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer
Participants\* must have recurrent disease, defined as: 1st relapse 3 to 6 months after completion of the last dose of primary platinum containing treatment, or 2nd or 3rd relapse within 6 months after completion of the last dose of the latest platinum-containing regimen (platinum-free interval within 6 months)
\*Prior treatment with PARPi is allowed. In bevacizumab-naive patients, bevacizumab can be included as part of treatment after tumor progression on study drugs according to local clinical practice
Participants must have had platinum-based chemotherapy in the first-line setting (at primary treatment or 1st relapse requiring chemotherapy)
For BRCA status, samples must be available for analysis; for HRD status, samples should be available for analysis, if possible. If not already analyzed, the subject agrees to undergo analysis of HRD and BRCA status on primary tumor tissue and/or recurrent tumor tissue
ECOG performance status 0-2
Subjects must have at least 1 measurable disease according to RECIST 1.1 guidelines. Non-measurable disease must be evaluable using GCIG CA 125 criteria (CA 125 ≥ 2 x upper limit of normal \[ULN\]). If the subject has only 1 measurable lesion, this should not be the same lesion used for biopsy, nor should it be in a previously irradiated area.
Able to take oral medications
Adequate organ function: Absolute neutrophil count ≥ 1.5 x 10\^9/L, Platelets \> 100 x 10\^9/L, Hemoglobin ≥ 80 g/dl, Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault formula, Total bilirubin ≤ ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ ULN
Consent to biopsy taken prior to starting treatment and Week 8 (± 1 week) of treatment
At least 18 years of age
Life expectancy of at least 12 weeks
Women of childbearing potential must use adequate birth control for the study duration and 6 months afterwards. She must use contraceptive methods with a failure rate of \< 1% to prevent pregnancy\* and drug exposure of a partner. Male partners must refrain from donating sperm from their partner's first IMP dose until 6 months after their partner's last IMP dose.
\* Combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion, vasectomy, and sexual abstinence.
Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements
Able to fully understand and participate in study-related procedures, including compliance and patient reported outcome
Written informed consent. Subjects must give informed consent prior to any study-specific procedure
Primary platinum-refractory disease, defined as tumor progression during or within 12 weeks from end of first platinum treatment
Concurrent cancer therapy (including anti-hormonal therapy for breast cancer unless it is omitted at the latest at study enrollment).
Received other than platinum-containing therapy for primary disease (first-line treatment)
Received non-platinum-containing chemotherapy line (e.g. weekly paclitaxel) in treatment of recurrent ovarian cancer. Maintenance with bevacizumab and/or PARP-inhibitor is allowed.
Treatment with an investigational agent concurrently, or where the last dose was administered within 5 elimination half-lives or where pharmacological activity may still be present as assessed by the Investigator.
You may not be if
Immunodeficiency or organ transplant. Autoimmune or inflammatory condition that requires immunosuppressive or steroid therapy during the course of the study. Subjects using immunosuppressive medications within 14 days prior to the first IMP dose, except for topical medications (intranasal, inhaled, local injection, systemic \[prednisolone equivalent 10 mg/day or less\]) or as needed for hypersensitivity reactions such as CT scan premedication.
Live vaccines within 28 days prior to the first IMP dose
Major surgery within 28 days prior to the first IMP dose, or not recovered from previous surgery to CTCAE (v5) grade 1 equivalent
Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
Transient ischemic attack (TIA) or stroke, including bleeding, within the past 6 months
Brain metastases
Major cardiac dysfunction defined as \> NYHA II
Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
Serious, uncontrolled, and active infection at enrollment, as determined by the Investigator
Pregnancy or breastfeeding
Persistence of clinically relevant therapy-related toxicity from previous chemotherapy (≥ CTCAE grade 3, except for liver and gastrointestinal ≥ CTCAE grade 2)
Need for concomitant use of drugs that are: moderate or strong inhibitors of CYP3A4 that may increase concentrations of KAND567; Inducers of CYP3A4 that may decrease concentrations of KAND567; highly dependent on CYP2B6, CYP2C8 or CYP3A4 for their metabolism where KAND567 may increase their concentrations. Treatment with such drugs should have been stopped at least five half-lives before initiation of KAND567 therapy. A list of drugs was provided.
Continuous use of herbal preparations (e.g., St. John's wort) within 2 weeks prior to enrollment
Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (e.g., compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
Known or suspected hypersensitivity to any of the IMPs.
Clareo Health | A Study to Evaluate the Safety of KAND567, in Combination With Carboplatin Therapy, in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
