An Open-Label Study to Determine the Maximum Tolerated Dose and Evaluate the Efficacy and Safety of CEP-18770 in Patients With Relapsed Multiple Myeloma Refractory to the Most Recent Therapy

Cephalon13 sites in 1 country62 target enrollmentJanuary 2010

ConditionsMultiple Myeloma

InterventionsCEP-18770

DrugsCEP-18770

Overview

Phase: Phase 1
Intervention: CEP-18770
Conditions: Multiple Myeloma
Sponsor: Cephalon
Enrollment: 62
Locations: 13
Primary Endpoint: Overall Response Rate (ORR)
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective for part 1 of the study is to determine the maximum tolerated dose (MTD) of CEP-18770 in patients with relapsed and refractory multiple myeloma. The primary objective for part 2 is to evaluate the antitumor activity of CEP-18770 in patients treated at the MTD.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

January 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cephalon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient has:
•relapsed multiple myeloma that has progressed following therapies that included bortezomib and an IMiD (thalidomide or lenalidomide) either alone or in any combination.
•multiple myeloma, which is refractory to the most recent therapy (bortezomib or IMiD, or any other chemotherapy), or the patient did not tolerate and discontinued the most recent therapy for multiple myeloma but has recovered from its toxic effects.
•measurable disease defined as 1 of the following:
•serum M-protein ≥0.5 g/dL
•urine M-protein ≥200 mg/24 hours
•a life expectancy of more than 3 months.
•an ECOG performance status of 0, 1, or
•adequate hepatic organ function.
•an absolute neutrophil count (ANC), hemoglobin level, and platelet count within protocol-specific ranges.

Exclusion Criteria

•The patient:
•has nonmeasurable multiple myeloma.
•received glucocorticoid therapy (prednisone \>10 mg/day orally or equivalent) within the last 2 weeks prior to the first dose of study drug.
•has POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy or monoclonal proliferative disorder, and skin changes).
•has plasma cell leukemia.
•received chemotherapy with approved anticancer therapeutics within 2 weeks, or within 5 drug half-lives (t1/2), or investigative anticancer therapeutics within 4 weeks, or within 5 drug half-lives (t1/2), before the first dose of study drug, whichever time is greater.
•received radiation therapy or immunotherapy in the 4 weeks prior to, or localized radiation therapy within 1 week prior to, the first dose of study drug.
•received prior treatment with CEP-
•has used a medication known to be a potent inducer of CYP2E1, CYP2D6 or CYP3A4/5 within 4 weeks prior to the first dose of study drug.
•has used a medication known to be a potent inhibitor of CYP2E1, CYP2D6 or CYP3A4/5 within 2 weeks prior to the first dose of study drug.

Arms & Interventions

1

CEP-18770

Intervention: CEP-18770

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Time Frame: Every 4 weeks, until completion of treatment

Secondary Outcomes

Elapsed time from the ORR date to the date of disease progression (DOR)(at disease progression)
Elapsed time from the date of first dose of CEP-18770 to the date of first response (TTR) to treatment with CEP-18770(at date of first response (TTR) to treatment)
Elapsed time from the date of first dose of CEP-18770 to the date of disease progression (TTP)(at date of disease progression (TTP))