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A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML

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ClinicalTrials.gov Identifier: NCT03547115
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
MEI Pharma, Inc.

Brief Summary:
This is a Phase 1, open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib in subjects with relapsed/refractory B cell malignancies or AML after treatment with standard therapy.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma (FL) Mantle Cell Lymphoma (MCL) Marginal Zone Lymphoma (MZL) Small Lymphocytic Lymphoma (SLL) Chronic Lymphocytic Leukemia (CLL) Diffuse Large B-cell Lymphoma (DLBCL) Acute Myeloid Leukemia (AML) Drug: Voruciclib Phase 1

Detailed Description:

This is a Phase 1, open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib in subjects with relapsed/refractory B cell malignancies or AML after treatment with standard therapy.

There will be up to 5 dose level cohorts. Up to 6 subjects will be enrolled per dose cohort and dose escalation will be allowed after 3 subjects have completed 1 cycle with no reported dose limiting toxicities (DLTs) or 6 subjects completed 1 cycle with no more than 1 DLT. Escalation to the next higher dose level will depend on demonstrated safety and tolerability.

Subjects may continue to receive voruciclib while there is evidence of clinical benefit and acceptable toxicity as judged by the investigator.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a Phase 1, open-label, 3 + 3 dose escalation study to determine the safety and preliminary efficacy of voruciclib.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Voruciclib
Open-label, 3 + 3 dose escalation study with 5 planned cohorts of Voruciclib which may enroll up to 6 subjects each
Drug: Voruciclib
Voruciclib is provided as 50 mg and 100 mg capsules and is administered orally once a day




Primary Outcome Measures :
  1. Determine the safety and tolerability of Voruciclib [ Time Frame: 2 years ]

    Safety will be measured by the incidence of all AEs and SAEs, timing, grade [CTCAE v4.03] severity, seriousness, relatedness.

    Tolerability will be measured by the incidence of DLTs (dose limiting toxicities)



Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 2 years ]
    defined as the sum of complete response (CR), complete remission with incomplete marrow recovery (CRi) and partial response (PR) for B-cell malignancies, or for AML the sum of CR/CRi rate by the 2017 European LeukemiaNet (ELN) criteria

  2. Duration of Response (DOR) [ Time Frame: 2 years ]
    defined as the time from the initial determination of response to the time of disease progression or death on study, which ever occurs first

  3. Rate of CR/CRi [ Time Frame: 2 years ]
    defined as the proportion of subjects with CR and CRi (i.e 2 CRs or CRis at least 28 days apart) according to IWG criteria

  4. Progression Free Survival (PFS) [ Time Frame: 2 years ]
    defined as the time from the first dose of study drug administration (Cycle 1 Day 1) to disease recurrence or progression as defined by IWG criteria, or death on study

  5. Evaluate the PK of Voruciclib [ Time Frame: 2 years ]
    Determined by the Area Under the Concentration time curve (AUC)

  6. Evaluate the PK of Voruciclib Cmax [ Time Frame: 2 years ]
    Determined by Peak Plasma Concentration (Cmax)



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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

Inclusion Criteria:

  • Age ≥18 years
  • Histologically-confirmed diagnosis of Follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia(CLL), diffuse large B-cell lymphoma (DLBCL), or AML

    a. Subjects must have disease that has relapsed or is refractory to 2 or more prior regimens and in need of treatment due to progressive disease

  • Presence of measurable disease defined per the 2008 International workshop on CLL guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma (does not apply for AML subjects)
  • Adequate hematologic parameters unless clearly due to the disease under study
  • Adequate renal and hepatic function, per laboratory reference range at screening

Exclusion Criteria:

  • For CLL subjects: only known histological transformation to an aggressive lymphoma
  • For AML subjects:

    1. Acute promyelocytic leukemia
    2. Peripheral blast count > 25 × 10 9/L
  • Known central nervous system involvement
  • Significant cardiovascular disease
  • Significant screening ECG abnormalities
  • Subjects who require warfarin, anti-cancer therapeutics or investigational agents
  • Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) at the time of start of voruciclib therapy
  • Receipt of an allogeneic transplant within 6 months or an autologous transplant within the preceding 3 months; evidence of ongoing graft-versus-host disease (GVHD)
  • Prior therapy with a cyclin-dependent kinase (CDK9) inhibitor
  • Ongoing immunosuppressive treatment at the time of the start of voruciclib therapy, including systemic or enteric corticosteroids except as follows:

    1. Prior to the start of voruciclib therapy, subjects may be using systemic corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled corticosteroids
    2. During study therapy, subjects may use systemic, topical, or enteric corticosteroids, if needed

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): NCT03547115


Contacts
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Contact: MEI Pharma 858-369-7100 Patients@meipharma.com

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
New York University Recruiting
New York, New York, United States, 10016
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
MEI Pharma, Inc.

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Responsible Party: MEI Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03547115     History of Changes
Other Study ID Numbers: ME-522-001
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MEI Pharma, Inc.:
B-Cell Malignancies, AML, Voruciclib, Cyclin Dependent Kinase Inhibitor

Additional relevant MeSH terms:
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Voruciclib
Lymphoma
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoma, Follicular
Neoplasms
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action