UnknownPhase 1

Chk2 Inhibitor for Recurrent EpitheliAl periToneal, fallopIan or oVarian cancEr (CREATIVE Phase IA Trial)

South Korea36 participantsStarted 2020-12-17

Plain-language summary

This study aims to assess the safety and tolerability of PHI-101 in patients with platinum-resistance/refractory ovarian, fallopian tubal, and primary peritoneal cancer. This study also evaluates the pharmacokinetics of PHI-101 and efficacy of PHI-101 during treating platinum-resistance/refractory ovarian, fallopian tubal, and primary peritoneal cancer. PHI-101 is a CHK2 inhibitor that is a checkpoint kinase binding specifically to CHK2, rather than CHK1, and it inhibits the DDR system by inhibiting the ATM-CHK2 pathway, which is activated in response to DSBs. When a high-grade serous ovarian (HGSO) cancer cell line and various ovarian cancer cell lines (CAOV3, OVCAR3, SK-OV-03, and SW626) were treated with PHI-101 in a non-clinical study, the therapeutic effect of PHI-101 against ovarian cancer was demonstrated by a decrease in viability of ovarian cancer cells. In addition, a stronger growth inhibition effect was observed compared to that of treatment with olaparib or rucaparib alone, and a much stronger inhibition effect was observed when concomitantly used with paclitaxel, cisplatin, and topotecan. Based on the aforementioned results of the non-clinical studies, the potential of PHI-101 as a new treatment or concomitant cytotoxic chemotherapeutics for patients with ovarian cancer who are resistant to existing antineoplastic drugs was confirmed.

Who can participate

Age range19 Years

SexFEMALE

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Inclusion criteria

✓. Females aged ≥ 19 years at the time of informed consent
✓. Pregnancy (childbearing potential and planning a pregnancy) and breast-feeding status ① Women of non-childbearing potential, women who are not pregnant or breast-feeding, or women who are not planning a pregnancy during the study
✓. Indication
✓. Expected life expectancy ≥ 12 weeks
✓. \[ECOG PS\] ≤ 1 ECOG PS = Eastern Cooperative Oncology Group Performance Status
✓. Subjects who have adequate hepatic, renal, and hematological function confirmed by the following laboratory tests (a re-test will be allowed during the screening period) ANC ≥ 1,500/mm3 (without administration of G-CSF within 2 weeks prior to baseline) Hb ≥ 10.0 g/dL (without transfusion within 2 weeks prior to baseline) Platelet count ≥ 75,000/mm3 (without transfusion within 2 weeks prior to baseline) Total bilirubin ≤ 1.5 x ULN AST and ALT ≤ 3.0 x ULN\* (≤ 5 x ULN for patients with liver metastases or hepatocellular carcinoma) Serum creatinine (or CrCl) Serum creatinine ≤ 1.5 x ULN CrCl ≥ 60 mL/min (by Cockcroft-Gault equation)
✓. Prior antineoplastic therapy and treatment ① Prior cytotoxic chemotherapy ≤ 5 times
✓. Subjects who voluntarily decided to participate and provided written consent after they were given sufficient explanation of this study

What they're measuring

Proportion of patients with dose-limiting toxicity (DLT)

Timeframe: Subjects will be treated and observed for DLT through the end of the first cycle (Days 1-28)

Maximum tolerated dose

Timeframe: Through the first cycle (Day1-28)

Trial details

NCT IDNCT04678102

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Contact for this trial

Hee Seung Kim, MD

+82-2-2072-4863 bboddi0311@gmail.com

View on ClinicalTrials.gov More Platinum-resistant Ovarian Cancer trials