CLINICAL TRIALS PROFILE FOR CC-92480
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Clinical Trials for CC-92480
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT03374085 ↗ | A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) | Recruiting | Celgene | Phase 1/Phase 2 | This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM). RRMM patient previously treated with at least 3 prior regimens including lenalidomide or pomalidomide, a proteasome inhibitor and a CD38 antibody will be eligible. |
| NCT03803644 ↗ | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single Ascending Doses of CC-92480 in Healthy Subjects | Completed | Celgene | Phase 1 | This is a two-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of CC-92480 in healthy subjects. Part 1: Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of CC-92480 following administration of single oral doses in healthy adult subjects. Part 1 will consist of escalating single doses in sequential groups. Approximately 40 subjects will be enrolled into 5 planned dose level cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-92480 and 2 subjects will receive placebo according to the randomization schedule. Part 2 Part 2 is a single-center, open-label, randomized, 2-period, 2-way crossover study to explore the effect of food (Food and Drug Administration [FDA] standard high-fat breakfast) on the single-dose PK of CC-92480 in healthy adult subjects. |
| NCT03989414 ↗ | A Study to Determine the Recommended Dose and Regimen and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple M | Recruiting | Celgene | Phase 1/Phase 2 | This is an open-label, multicenter, Phase 1/2 study to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments. |
| NCT04211545 ↗ | Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects | Completed | Celgene | Phase 1 | This is a Phase 1, open-label, randomized, four-period, crossover study in healthy females of nonchildbearing potential and male subjects - to be conducted at a single center in the United States. The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow-up phone call. The 4 treatment periods are divided into two pairs (Period 1 and 2 and Period 3 and 4), potentially separated by an intermission during which subjects will be discharged from the research unit: Periods 1 and 2 support relative bioavailability (RBA) estimation, while Periods 3 and 4 support estimation of PPI effects. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for CC-92480
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Clinical Trial Locations for CC-92480
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Clinical Trial Progress for CC-92480
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Clinical Trial Sponsors for CC-92480
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