Status:
RECRUITING
Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
Lead Sponsor:
CellCentric Ltd.
Conditions:
Haematological Malignancy
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 M...
Detailed Description
This includes patients with Peripheral T-cell lymphoma.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04068597
Start Date
August 9 2019
End Date
March 31 2027
Last Update
December 18 2025
Active Locations (39)
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1
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
Community Health Network
Indianapolis, Indiana, United States, 46227
3
The Center for Cancer and Blood Disorders (CCBD)
Bethesda, Maryland, United States, 20817
4
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130