A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors



Status:Terminated
Conditions:Cancer, Cancer, Cancer, Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/16/2018
Start Date:May 2015
End Date:July 2018

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A Phase 1/2, Open-Label, Uncontrolled, Multiple Dose Escalation, Cohort Expansion Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Preliminary Efficacy Of Asn002 In Relapsed/Refractory Lymphoma, Myelofibrosis, Chronic Lymphocytic Leukemia, And Advanced Solid Tumors

This study is a dose escalation, and cohort expansion study in subjects with advanced cancer
for which no standard therapy exists. Subjects must have received prior treatment for cancer
that has not worked, or has stopped working.

The study will be conducted in two parts. Part A is a dose escalation study to determine a
safe and tolerable dose of ASN002 for subjects with relapsed or refractory lymphoma, or
advanced solid tumors. Part A will also characterize the pharmacokinetics and
pharmacodynamics of ASN002 through blood sampling. Subjects in Part B will enroll subjects
with four types of lymphoma Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL),
Mantle Cell Lymphoma (MCL) and Peripheral T-cell lymphoma (PTCL). Additional groups of
subjects with Myelofibrosis (MF) and Chronic Lymphocytic Leukemia (CLL) will be enrolled.
Subjects will be treated with the highest safe and tolerable dose determined in Part A of the
study to determine preliminary efficacy. Subjects may continue to receive ASN002 for up to 1
year in the absence of severe side effects or disease progression.

Inclusion Criteria:

- Written informed consent obtained prior to any study-related procedure being
performed;

- Male or female subjects at least 18 years of age at the time of consent;

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;

- Recovered from the reversible effects of prior antineoplastic therapy (with the
exception of alopecia and Grade 1 neuropathy).

- Screening blood counts of the following: Absolute neutrophil count ≥ 1000/μL,
Platelets ≥ 75,000/μL, Hemoglobin ≥ 8 g/dL (with transfusion support);

- Screening chemistry values of the following: Alanine aminotransferase (ALT) and
aspartate transaminase (AST) ≤ 3.0 × upper limit of the normal (ULN), total bilirubin
≤ 1.5 × ULN, Creatinine ≤ 1.5 × ULN;

- At screening, life expectancy of at least 3 months;

- Subject is willing and able to comply with all protocol required visits and
assessments;

- Male and female subjects of child-bearing potential must agree to use medically
acceptable methods of birth control throughout the study and for thirty (30) days
after the last dose of study medication.

- (Part A only) Histologically or cytologically confirmed metastatic and/or advanced
solid tumors or lymphomas for which no standard therapy exists, or who are not
eligible for standard treatment. Subjects must have received at least one prior
therapy for their malignancy;

- (Part B only) Histologically confirmed DLBCL/MCL/FL/PTCL/MF/CLL on the basis of
excisional lymph node or extranodal tissue biopsy; diagnosis of relapsed/refractory
disease defined as 1) recurrence of disease after a Complete Response (CR), or 2)
Partial Response (PR), Stable Disease (SD) at completion of treatment regimen
preceding entry into study, subjects must not be candidates for standard therapy,
subjects who have not received Stem Cell Translplant (SCT) must be ineligible to
receive SCT.

Exclusion Criteria

- Have received prior chemotherapy regimens within 4 weeks of Day 1;

- Have received prior treatment with monoclonal antibodies within 6 weeks of first dose
of Day 1;

- Have had major surgery within 30 days prior to the start of Day 1;

- Received any investigational treatment within 4 weeks prior to the start of study
medication;

- Have had an infection requiring the use of parenteral antibiotics within 14 days prior
to the start of Day 1;

- Have known central nervous system metastasis or Central Nervous System lymphoma;

- Is receiving high dose corticosteroids (>10 mg prednisone daily or equivalent);

- Has known bleeding diathesis that would be a safety risk;

- Has a history of other malignancy within the 3 years prior to screening, except
adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma
in-situ;

- Has difficulty swallowing medications, or known history of malabsorption syndrome;

- Has a serious concurrent medical condition, such as: congestive heart failure New York
Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening,
12-Lead electrocardiogram (ECG) abnormalities considered by the investigator to be
clinically significant including myocardial infarction, angioplasty, or cardiac stent
placement within the last 6 months, HIV infection, known Hepatitis B or C infection.
Subjects at high risk for Hepatitis B or C infection should have serology testing to
rule out infection, a medical condition requiring the therapeutic use of
anticoagulants.

- Known hypersensitivity to ASN002 or its excipients;

- Prior participation, i.e., receipt of study medication, in this study;

- Any condition that, in the opinion of the investigator, would impair the subject's
ability to comply with study procedures;

- Female subjects that are pregnant or lactating.

- Part B only: Prior treatment with SYK or Janus Kinase (JAK) inhibitors, except MF
subjects.
We found this trial at
13
sites
San Antonio, Texas 78229
Principal Investigator: Drew W. Rasco, M.D.
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Stephanie L Elkins, M.D.
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Andy I Chen, M.D.
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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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Moshe Talpaz, M.D.
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30322
Principal Investigator: Christopher Flowers, M.D.
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Atlanta, GA
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1500 Avenida Juan Domingo Perón
Buenos Aires, Derqui, Pilar
Principal Investigator: Gustavo Kusminsky, M.D.
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Buenos Aires,
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Y Gabrail, M.D.
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Canton, OH
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Dipti Patel-Donnelly, M.D.
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fairfax, VA
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Grand Rapids, Michigan 49503
Principal Investigator: Timothy J O'Rourke, MD, FACP
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Grand Rapids, MI
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Houston, Texas 77030
Principal Investigator: Michael Wang, M.D.
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Houston, TX
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Philadelphia, Pennsylvania 19111
Principal Investigator: Stefan Barta, M.D.
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San Francisco, California 94143
Principal Investigator: Larry Kaplan, M.D.
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San Francisco, CA
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7695 South Research Drive
Tempe, Arizona 85206
Principal Investigator: Kasra Karamlou, MD
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Tempe, AZ
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