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



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:May 31, 2018
End Date:December 31, 2020
Contact:MEI Pharma
Email:Patients@meipharma.com
Phone:858-369-7100

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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

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.

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.

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
We found this trial at
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sites
Seattle, Washington 98104
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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New York, NY
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