Trial Search Results

A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

This trial is studying an investigational drug called ACP-196 (acalabrutinib). The study drug, ACP-196 (acalabrutinib), is a type of drug that blocks proteins inside cells that help cells live and grow. It is possible that the study drug may kill the cancer cells or stop them from growing. The purposes of this study are to find out if the study drug will slow or stop CLL from getting worse and whether the study drug causes side effects.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Acerta Pharma BV

Stanford Investigator(s):

Intervention(s):

  • Drug: ACP-196 (acalabrutinib)

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Men and women ≥ 18 years of age.

   2. Prior diagnosis of CLL

   3. Must have received ≥ 1 prior therapy for CLL

   4. Intolerant of ibrutinib

   5. Willing and able to participate in all required evaluations and procedures in this
   study protocol including swallowing capsules without difficulty.

   6. ECOG performance status of ≤ 2.

Exclusion Criteria:

   1. Ongoing AE attributed to ibrutinib therapy

   2. Treatment with systemic anticancer therapy for CLL is prohibited between
   discontinuation of ibrutinib and enrollment on this trial.

   3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199)

   4. Prior malignancy (other than CLL), except for adequately treated basal cell or
   squamous cell skin cancer, in situ cancer, or other cancer from which the subject has
   been disease free for ≥ 2 years.

   5. Significant cardiovascular disease such as uncontrolled or symptomatic untreated
   arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
   screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart
   Association Functional Classification, or QTc > 480 msec at screening. Exception:
   Subjects with controlled, asymptomatic atrial fibrillation during screening are
   allowed to enroll on study.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting