A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
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|ClinicalTrials.gov Identifier: NCT02848001|
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : July 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute Myelodysplastic Syndromes||Drug: CC-90009||Phase 1|
Study CC-90009-AML-001 is an open-label, Phase 1, dose escalation and expansion, first-in-human clinical study of CC-90009 in subjects with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory high-risk myelodysplastic syndrome.
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-90009 in relapsed and refractory AML. The expansion part, (Part B), will further evaluate the safety and efficacy of CC-90009 administered at or below the maximum tolerated dose (MTD) in selected expansion cohorts of one or more dosing regimens in order to determine the recommended Phase 2 dose (RP2D) for subjects with relapsed or refractory AML and relapsed or refractory high-risk myelodysplastic syndrome.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes|
|Actual Study Start Date :||November 14, 2016|
|Estimated Primary Completion Date :||August 25, 2021|
|Estimated Study Completion Date :||February 26, 2022|
Experimental: CC-90009 - Part A
Will be administered intravenously per dosing schedule in a 28-day cycle.
Experimental: CC-90009 - Part B - AML and MDS patients
Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A
- Dose- limiting toxicity (DLT) [ Time Frame: Up to 42 days ]Number of participants with a DLT
- Non-tolerated dose (NTD) [ Time Frame: Up to 42 days ]Dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1 during dose escalation.
- Maximum tolerated dose (MTD) [ Time Frame: Up to 42 days ]Last dose level(s) below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT in Cycle 1 during dose escalation
- Pharmacokinetics-Cmax [ Time Frame: Up to Day 11 ]Maximum observed concentration in plasma
- Pharmacokinetics - AUC24 [ Time Frame: Up to Day 11 ]Area under the plasma concentration time-curve from time 0 to 24 hours
- Pharmacokinetics - tmax [ Time Frame: Up to Day 11 ]Time to peak (maximum) plasma concentration
- Pharmacokinetics - t 1/2 [ Time Frame: Up to Day 11 ]terminal half-life
- Pharmacokinetics - CL [ Time Frame: Up to Day 11 ]Total body clearance of the drug from plasma
- Pharmacokinetics - Vss [ Time Frame: Up to Day 11 ]Volume of distribution at steady-state
- Preliminary efficacy of CC-90009 [ Time Frame: Up to 2.5 years ]Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)
- Preliminary efficacy of CC-90009 - AML [ Time Frame: Up to 2.5 years ]Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML.
- Preliminary efficacy of CC-90009 - MDS [ Time Frame: Up to 2.5 years ]Determined by myelodysplastic syndrome (MDS) response rate based on the International Working Group (IWG) response criteria for Myelodysplasia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848001
|Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,||please email:||Clinical.Trials@bms.com|
|Contact: First line of the email MUST contain NCT # and Site #.|
|Study Director:||August Dietrich, MD||Celgene|