A Phase I/II Study to Assess the Safety and Tolerability of the Combination of Oral ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

What's the purpose of the trial?

Multiple myeloma (MM) is a malignancy characterized by uncontrolled proliferation of plasma cells for which there is an urgent and unmet need to develop new, effective therapeutics. Onconova Therapeutics has developed a first-in-class oral inhibitor of CDK4 and ARK5 ON 123300 (NARAZACICLIB) which shows potent anti-myeloma activity in vitro and in vivo in preclinical models, and is undergoing evaluation in Phase 1-2 trials worldwide. In this study, the researchers will test the safety and preliminary efficacy of inhibition of CDK4 and ARK5 by ON 123300 (NARAZACICLIB) in combination with dexamethasone in myeloma patients in a Phase I/II clinical trial.
Trial status

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Phase
Phase 1/2
Enrollment
36
Last Updated
2 weeks ago
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Experimental Treatments

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  • Dexamethasone is a corticosteroid that prevents the release of substances in the body that cause inflammation, and is given in conjunction with some cancer treatments.
  • Narazaciclib is a multi-kinase inhibitor that targets CDK4 and ARK5 proteins found on cancer cells.

Arms / Cohorts

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ON 123300 (NARAZACICLIB) + Dexamethasone

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