Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.
CellCentric Ltd.
250 participants
Aug 9, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria10
- 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 toxicities from prior therapy \>CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
- Any evidence of severe or uncontrolled systemic diseases
- Any known uncontrolled inter-current illness
- QTcF prolongation (\> 470 msec)
Interventions
Oral capsule
oral capsule
oral tablet
Powder suspension for Injection
Oral tablet
Powder for solution for injection
Oral capsule
Solution for injection
Solution for injection
Oral capsule
Solution for injection, concentrate for solution for infusion
Locations(39)
View Full Details on ClinicalTrials.gov
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NCT04068597