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Study of a Tankyrase Inhibitor RK-582 for Patients With Unresectable Metastatic Colorectal Cancer

RecruitingPhase 1Ages 18 Years - anyAllEiji Shinozaki
NCT06853496 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Tankyrase, the fifth and sixth members of the poly(ADP-ribose) polymerase (PARP) family (PARP-5a/b), is responsible for poly(ADP-ribosyl)ation (PARylation), and was originally identified as a factor that promotes the function of telomerase, an enzyme that elongates telomeres. Subsequently, it was reported that tankyrase enhances Wnt/beta-catenin signaling by PARylation and subsequent degradation of AXIN, a negative regulator of Wnt/beta-catenin signaling, suggesting that tankyrase inhibitors may be a new treatment for colorectal cancer. RK-582 was discovered through lead optimization from a tankyrase inhibitor that suppresses the growth of human colorectal cancer cells. It was confirmed that RK-582 selectively inhibited tankyrase among the PARP family enzymes, suppressed the growth of Wnt/beta-catenin signal-dependent human colorectal cancer cells at both the levels of cultured cells an

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with histologically or cytologically diagnosed colorectal cancer * Patients who are refractory or intolerant to standard treatment for unresectable advanced or recurrent colorectal cancer * Patients with measurable disease according to RECIST guideline ver 1.1 * Patients who are able to take capsules orally Exclusion Criteria: * Patients with clinically relevant gastrointestinal, hepatic, musculoskeletal, respiratory, cerebral/cardiovascular, hematologic, oncologic, endocrine, immunologic, psychiatric, neurologic, or genitourinary diseases, or patients with conditions that are judged to threaten the safety of the participant or to affect the outcome of this clinical trial by the investigators * Patients with medical history of interstitial lung disease * Patients with chronic nausea, vomiting or diarrhea that may interfere with oral administration of the investigational drug * Patients with pulmonary embolism or central deep vein thrombosis. * Patients receiving treatment with strong CYP3A4 inhibitors or inducers. * Patients diagnosed and treated for osteoporosis or patients with a bone mineral density of less than T-score -2.5 at the time of screening * Patients with obvious bone metastases in the long bones, vertebrae, or other parts of the leg where gravity is applied
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What it tests

  • RK-582
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Where

1 site
Cancer Institute Hospital of JFCR
Koto-ku, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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