Phase 1 Dose Escalation Study in Chronic Lymphocytic Leukemia and Non-hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Portola Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01994382
First received: November 8, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

This study will identify the highest dose, and assess the safety, of PRT062070 that may be given in patients with relapsed/refractory chronic lymphocytic leukemia or non-hodgkin lymphoma


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
B-cell Non Hodgkin Lymphoma (NHL)
Drug: PRT062070
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Open-Label, Multi-Dose, Dose Escalation Study Of PRT062070 In Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Or B-Cell Non Hodgkin Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by Portola Pharmaceuticals:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) of PRT062070 in patients with relapsed/refractory CLL, SLL or B-cell NHL. [ Time Frame: Approximately 84 days (baseline to end of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of dose limiting toxicity (as classified by Common Terminology Criteria for Adverse Events (CTCAEv4) by dose level. [ Time Frame: Approximately 114 days (baseline to 30 days post last treatment) ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of PRT602070. [ Time Frame: Baseline to day 22 ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: August 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRT062070
PRT062070 dose escalation study
Drug: PRT062070
PRT062070 oral pill

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have a diagnosis of CLL/SLL or B-cell Non-Hodgkin lymphoma (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL], mantle cell lymphoma [MCL], MALT lymphoma, marginal zone lymphoma [MZ], lymphoplasmacytic lymphoma)
  • Patient must be 18 years or older, of either sex, and of any race.
  • Diagnosis of CLL/SLL or B-cell Non-Hodgkin lymphoma (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL], mantle cell lymphoma [MCL], MALT lymphoma, marginal zone lymphoma [MZ], lymphoplasmacytic lymphoma)
  • Progression on at least one prior treatment regimen and no standard therapy exists
  • ECOG Performance Score of 0 or 1.
  • 18 years or older, of either sex, and of any race.
  • Adequate hematologic, renal and hepatic function

Exclusion Criteria:

  • Prior allogeneic stem cell transplant
  • Known lymphomatous involvement of the central nervous system (CNS).
  • Investigational therapy within 30 days or 5 half-lives
  • Known HIV, hepatitis B or hepatitis C infection or is known to be a carrier of hepatitis B or C.
  • Receiving systemic steroids at doses greater than the equivalent of prednisone, 20 mg daily
  • Female and is breast-feeding, pregnant or intends to become pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994382

Locations
United States, Florida
Florida Cancer Specialists/Sarah Cannon Research Institute Recruiting
Sarasota, Florida, United States, 34232
Contact: Heather Pedigo    615-329-7432    pedigo@scresearch.net   
Principal Investigator: Manish Patel, MD         
United States, Tennessee
Tennessee Oncology/Sarah Cannon Research Insitute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Heather Pedigo       Heather.pedigo@scresearch.net   
Principal Investigator: Ian Flinn, MD         
Sponsors and Collaborators
Portola Pharmaceuticals
Investigators
Study Director: Sandra Russell Portola Pharmaceuticals
  More Information

No publications provided

Responsible Party: Portola Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01994382     History of Changes
Other Study ID Numbers: 13-601
Study First Received: November 8, 2013
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Portola Pharmaceuticals:
Leukemia
Lymphocytic
Chronic
B Cell

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014