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ACP-196 in Combination With ACP-319, for Treatment of B-Cell Malignancies

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ClinicalTrials.gov Identifier: NCT02328014
Recruitment Status : Unknown
Verified February 2016 by Acerta Pharma BV.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy ACP-196 and ACP 319 in B-cell malignancies.

Condition or disease Intervention/treatment Phase
Non-hodgkins Lymphoma Multiple Myeloma B-All Drug: ACP-196 and ACP-319 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Proof-of-Concept Study of the Combination of ACP-196 and ACP-319 in Subjects With B-cell Malignancies
Study Start Date : December 2014
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: Dose Escalation
The ACP-196 dose will be fixed and the ACP 319 dose will be escalated in each cohort.
Drug: ACP-196 and ACP-319
Dose escalation

Experimental: Expansion
Will commence once the safety and efficacy results from the dose escalation cohorts of the study indicate further evaluation of the combination is warranted.
Drug: ACP-196 and ACP-319
Dose expansion




Primary Outcome Measures :
  1. Incidence of adverse events from the combination of ACP-196 and ACP-319 [ Time Frame: up to 12 month ]

Secondary Outcome Measures :
  1. Overall response rate of the combination of ACP-196 and ACP-319 [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Diagnosis of a b-cell malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO).
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Agreement to use contraception during the study and for 90 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria

  • 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 study drugs, or put the study outcomes at undue risk.
  • Central nervous system (CNS) involvement by lymphoma/leukemia
  • Any therapeutic antibody within 4 weeks of first dose of study drugs.
  • The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drugs is < 5 times the half-life of the previously administered agent(s).
  • ANC < 0.5 x 10^9/L or platelet count < 50 x 10^9/L unless due to disease involvement in the bone marrow.
  • Creatinine > 1.5 x institutional upper limit of normal (ULN); total bilirubin > 1.5 x ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 x ULN.

Information from the National Library of Medicine

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): NCT02328014


Contacts
Contact: Alinna Lee 650-591-2800 ext 172 alinna.lee@acerta-pharma.com
Contact: Sara Rodriguez, MHA +1 650 591-4024 s.rodriguez@acerta-pharma.com

Locations
United States, Georgia
Not yet recruiting
Atlanta, Georgia, United States
United States, Maryland
Recruiting
Bethesda, Maryland, United States
United States, New York
Recruiting
Rochester, New York, United States
United States, Oregon
Recruiting
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Not yet recruiting
Philidelphia, Pennsylvania, United States
United States, Texas
Recruiting
Austin, Texas, United States, 78705
Not yet recruiting
Houston, Texas, United States
United States, Washington
Recruiting
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Peter Lee, MD Medical Monitor

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02328014     History of Changes
Other Study ID Numbers: ACE-LY-001
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016

Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Btk
B-Cell Malignancies
Mantle Cell
Multiple Myeloma
CLL
SLL
DLBCL
Folicular
Waldenstrom
B-All

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Lymphatic Diseases