NCT04068597 Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
| NCT ID | NCT04068597 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | CellCentric Ltd. |
| Condition | Haematological Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2019-08-09 |
| Primary Completion | 2027-03-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.
Eligibility Criteria
Inclusion Criteria: * Provision of consent * ECOG performance status 0-2 * Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML) * Must have previously received standard therapy * Adequate organ function Exclusion Criteria: * Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose * Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment * Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment * Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment * Patients should discontinue statins prior to starting study treatment * CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment * Any unresolved reversible toxic