Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

Launched by CELLCENTRIC LTD. · Aug 22, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called CCS1477 for patients with certain blood cancers, including Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, and higher-risk Myelodysplastic Syndrome. It aims to find out how safe the treatment is, how well it works, and how the body processes it. The trial is currently recruiting participants aged 65 and older who have had their cancer come back or have not responded to previous treatments. To join, patients need to be in relatively good health (with a performance status of 0-2) and must have already tried standard cancer therapies.

Participants in this trial will receive the new treatment and will be monitored closely for any side effects. Before starting, they should not have had any chemotherapy or major surgeries recently, and they need to stop taking certain medications that might interfere with the study treatment. This study is important because it could help improve treatment options for people with these challenging blood cancers. If you're interested in learning more or think you might qualify, it's a good idea to talk to your doctor.

Gender

ALL

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 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 (\> 480 msec)