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Back|NCT04068597Recruiting
Official Title

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.

Phase
Phase 1/Phase 2
Sponsor
CellCentric Ltd.
Enrollment
250
Timeline
Aug 2019 → Mar 2027
About This Study

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

  • 1Provision of consent
  • 2ECOG performance status 0-2
  • 3Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)
  • 4Must have previously received standard therapy
  • 5Adequate organ function

Exclusion Criteria

  • 1Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
  • 2Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
  • 3Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  • 4Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
  • 5Patients should discontinue statins prior to starting study treatment
  • 6CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  • 7Any unresolved reversible toxicities from prior therapy \>CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
  • 8Any evidence of severe or uncontrolled systemic diseases
  • 9Any known uncontrolled inter-current illness
  • 10QTcF prolongation (\> 470 msec)

Locations

39 sites participating in this study

Emory Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Dr Nisha Joseph, MD

Community Health Network

Indianapolis, Indiana 46227

Recruiting

Pablo M Bedano, MD

The Center for Cancer and Blood Disorders (CCBD)

Bethesda, Maryland 20817

Recruiting

Victor Priego, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →