A Multicenter, Open-label, Phase 1 Pilot Study of ACP-196 in Combination With ACP-319 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia

Acerta Pharma BV1 site in 1 country12 target enrollmentAugust 18, 2014

ConditionsChronic Lymphocytic Leukemia

Interventionsacalabrutinib ACP-319

Overview

Phase: Phase 1
Intervention: acalabrutinib
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Acerta Pharma BV
Enrollment: 12
Locations: 1
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is evaluating the safety and efficacy of the combined use of acalabrutinib and ACP-319, for the treatment of chronic lymphocytic leukemia (CLL)

Registry

clinicaltrials.gov

Start Date

August 18, 2014

End Date

April 1, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Acerta Pharma BV

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women ≥ 18 years of age with a confirmed diagnosis of CLL, which has relapsed after, or been refractory to, ≥ 1 previous treatments for CLL; however, subjects with 17p deletion are eligible if they have relapsed after, or been refractory to, 1 prior treatment for CLL.
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤
•Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria

•Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years.
•A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib and/or ACP-319, or put the study outcomes at undue risk.
•Significant cardiovascular disease.
•Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
•Any immunotherapy within 4 weeks of first dose of study drug.
•For subjects with recent chemotherapy or experimental therapy the first dose of study drug must occur after 5 times the half-life of the agent(s).
•History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
•Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for treatment of CLL or other conditions. Note: Subjects may be using topical or inhaled corticosteroids as therapy for comorbid conditions.
•Central nervous system (CNS) involvement by CLL.
•Grade ≥ 2 toxicity (other than alopecia).

Arms & Interventions

acalabrutinib

Starts with acalabrutinib for 7 days, then combined with ACP-319 afterwards.

Intervention: acalabrutinib

acalabrutinib

Starts with acalabrutinib for 7 days, then combined with ACP-319 afterwards.

Intervention: ACP-319

ACP-319

Starts with ACP-319 for 7 days, then combined with acalabrutinib afterwards.

Intervention: acalabrutinib

ACP-319

Starts with ACP-319 for 7 days, then combined with acalabrutinib afterwards.

Intervention: ACP-319

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

Time Frame: From date of randomization until the day of documented progression or date of death from any cause, whichever came first, assessed up to 60 cycles of 28 days.

The frequency (number and percentage) of treatment-emergent AEs will be reported in each treatment group by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class and Preferred Term. Summaries will also be presented by the severity of the AE (per CTCAE, v4.03) and by relationship to study drug.

Secondary Outcomes

Duration of Response(Pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. After that at cycle 48 and 60 of 28 day cycles.)
Drug Exposure, Maximum observed plasma concentration(From 30 min before first dose to 30 min before day-28 of cycle-6 of 28 day cycles)
Drug Exposure, Time of the maximum plasma concentration(From 30 min before first dose till 30 before day-28 of cycle-6 of 28 day cycles)
Drug Exposure, Area Under the Plasma Concentration-time Curve(From 30 min before first dose to day-28 of cycle-6 of a 28 day cycle)
Progression-Free Survival(Pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. After that at cycle 48 and 60 of 28 day cycles.)
Overall Response rate(Pretreatment, then end of cycles 2, 4, 9, 12, 18 and then every 6 cycles to cycle 36. After that at cycle 48 and 60 of 28 day cycles.)