Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

This study is currently recruiting participants.
Verified December 2013 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01905813
First received: June 19, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

The study design includes a dose escalation phase to determine the maximum tolerated dose (MTD) of a PI3Kδ inhibitor, INCB040093, or a tolerated, pharmacologically active dose; followed by an expansion phase at the chosen dose as monotherapy and in combination with INCB039110.


Condition Intervention Phase
B-cell Malignancies
Drug: INCB040093
Drug: INCB040093 + INCB039110
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Phase 1: Safety and tolerability as determined by clinical laboratory assessments, physical exams, 12-lead ECG and summary of adverse events during cycle 1 [ Time Frame: Measured every 3 weeks until progression. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Preliminary efficacy as assessed by Overall Response Rate (ORR) as measured by published criteria for lymphoma and Chronic Lymphocytic Leukemia (CLL) (Cheson et el 2007). [ Time Frame: Every 12 weeks (4 cycles) until progression. ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) collections. [ Time Frame: Measured for each patient 1 time at Cycle 1 Day 1 and Cycle 1 Day 15. ] [ Designated as safety issue: No ]
    Plasma concentrations of each INCB040093 and INCB039110 will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).


Estimated Enrollment: 50
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB040093 Drug: INCB040093
Escalating doses starting at 100 mg QD
Drug: INCB040093
INCB040093 monotherapy - dose to be determined at completion of Phase I of the study
Experimental: INCB040093 in combination with INCB039110 Drug: INCB040093 + INCB039110
INCB040093 dose to be determined at completion of Phase I of the study + INCB039110 at a starting dose of 400 mg,QD with escalations planned up to 600 mg QD.

  Eligibility

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

Inclusion Criteria:

  • Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows:

    • Indolent / aggressive B-cell (NHL) Non- Hodgkin's Lymphoma EXCLUDING: Burkitt lymphoma and precursor B-lymphoblastic leukemia/lymphoma INCLUDING: any non-Hodgkin's B-cell malignancy such as CLL and rare non-Hodgkin's B-cell subtypes such as Hairy Cell Leukemia, Waldenstrom macroglobulinemia, Mantle cell lymphoma, etc.
    • Hodgkin's lymphoma
  • Life expectancy of 12 weeks or longer.
  • Subject must have received ≥ 1 prior treatment regimen.
  • The subject must not be a candidate for potentially curative therapy, including stem cell transplant.

Additionally: for Expansion Cohort B the following conditions must be met:

  • Have relapsed or refractory indolent B-cell NHL or CLL be CD20+ and have been previously treated with rituximab
  • Must be currently eligible to receive rituximab.

Exclusion Criteria:

  • Received an investigational study drug within 28 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study drug.
  • Received any approved anticancer medications within 21 days or 5 half-lives (whichever is longer) prior to receiving their first dose of study drug (42 days for nitrosoureas) EXCEPT steroids at ≤ 10 mg prednisone daily (or equivalent).
  • Has any unresolved toxicity ≥ Grade 2 from previous anticancer therapy.
  • Has history of brain metastases or spinal cord compression, or lymphoma involving the central nervous system.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3.
  • Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or is currently receiving immunosuppressive therapy following allogeneic transplant.
  • Received autologous hematopoietic stem cell transplant within the last 3 months.
  • Laboratory Parameters:

    • Has any of the following laboratory values at screening unless resulting from underlying malignancy:

      1. Hemoglobin ≤ 9.0 g/dL
      2. Platelet count ≤ 100 x 109/L (in no case < 50 x 109/L)
      3. Absolute neutrophil count (ANC) ≤ 1.50 x 109/L (in no case < 1.0 x 109/L)
    • Has any of the following laboratory results at screening irrespective of causality:

      1. Conjugated bilirubin ≥ 1.2 x upper limit of normal (ULN) (need only be tested if total bilirubin exceeds ULN)
      2. Alkaline phosphatase (ALP) ≥ 2.5 x ULN (or ≥ 5 x ULN if bone metastases are present and hepatic parenchymal metastases are absent)
      3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x ULN.
      4. Creatinine clearance of < 50 mL/min based on Cockroft-Gault formula.
  • Known history of infection with the human immunodeficiency virus (HIV).
  • History of active hepatitis or positive serology for hepatitis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01905813

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
United States, Florida
Not yet recruiting
Jacksonville, Florida, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
United States, Minnesota
Not yet recruiting
Rochester, Minnesota, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Lance Leopold, M.D. Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01905813     History of Changes
Other Study ID Numbers: INCB 40093-102
Study First Received: June 19, 2013
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014