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Trial record 13 of 80 for:    ASNS

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

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ClinicalTrials.gov Identifier: NCT02440685
Recruitment Status : Terminated (Business decision)
First Posted : May 12, 2015
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Asana BioSciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Follicular Cancer Neoplasm Tumor Lymphoma, Malignant Lymphoma, B-cell Lymphoma, Non-Hodgkin B-Cell Chronic Lymphocytic Leukemia B-Cell Leukemia, Chronic B-Lymphocytic Leukemia, Chronic Chronic Lymphocytic Leukemia Leukemia, Lymphocytic, Chronic Leukemia, Lymphocytic, Chronic, B Cell Myelofibrosis Chronic Idiopathic Myelofibrosis Idiopathic Myelofibrosis Lymphoma, T Cell, Peripheral Peripheral T-Cell Lymphoma T-Cell Lymphoma, Peripheral Drug: ASN002 Dose Escalation Drug: ASN002 RD Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: ASN002 Dose Escalation
Multiple ascending doses of ASN002 will be administered to determine the maximum tolerated dose (MTD). Arm Closed
Drug: ASN002 Dose Escalation
Multiple ascending doses of ASN002 assigned by cohort

Experimental: ASN002 Recommended dose (RD) - DLBCL
ASN002 administered at the recommended dose in subjects with DLBCL. Arm Closed
Drug: ASN002 RD
Recommended dose of ASN002 from Part A

Experimental: ASN002 RD - Mantle Cell Lymphoma
ASN002 administered at the recommended dose in subjects with MCL. Arm Closed
Drug: ASN002 RD
Recommended dose of ASN002 from Part A

Experimental: ASN002 RD - Follicular Lymphoma
ASN002 administered at the recommended dose in subjects with FL.
Drug: ASN002 RD
Recommended dose of ASN002 from Part A

Experimental: ASN002 RD - Peripheral T-cell Lymphoma
ASN002 administered at the recommended dose in subjects with PTCL.
Drug: ASN002 RD
Recommended dose of ASN002 from Part A

Experimental: ASN002 RD - Myelofibrosis
ASN002 administered at the recommended dose in subjects with MF.
Drug: ASN002 RD
Recommended dose of ASN002 from Part A

Experimental: ASN002 RD - Chronic Lymphocytic Leukemia
ASN002 administered at the recommended dose in subjects with CLL.
Drug: ASN002 RD
Recommended dose of ASN002 from Part A




Primary Outcome Measures :
  1. Part A: Determine the maximum tolerated dose (MTD) of ASN002 [ Time Frame: First 28 days ]
    The MTD will be determined by evaluating the number of subjects with treatment related dose limiting toxicity. This is the primary endpoint of Part A

  2. Part B: evaluate the overall response rate (number of Complete Responses + Partial Responses) in subjects receiving ASN002 for the treatment of lymphoma, MF and CLL. [ Time Frame: First 6 months ]
    Change from baseline in the severity of disease, This is the primary endpoint for Part B.


Secondary Outcome Measures :
  1. Calculate the pharmacokinetic area under the plasma concentration (AUC) of ASN002 [ Time Frame: First 29 days ]
    Calculate the amount of ASN002 in the bloodstream

  2. Calculate the maximum plasma concentration (Cmax) at steady state. [ Time Frame: First 29 days ]
    Calculate the maximum amount of ASN002 in the bloodstream

  3. Calculate the terminal elimination rate (T 1/2). [ Time Frame: First 29 days ]
    Calculate how fast ASN002 leaves the body


Other Outcome Measures:
  1. To evaluate the change from baseline in the intensity of Phospho-STAT3 protein found in the blood of patients with lymphoma. [ Time Frame: First 29 days ]
    Evaluate the effect of ASN002 on tumor biomarkers

  2. To evaluate the change from baseline in the intensity of Phospho-S6 protein found in the blood of patients with lymphoma. [ Time Frame: First 29 days ]
    Evaluate the effect of ASN002 on biomarkers

  3. To evaluate the change from baseline in the intensity of Phospho-spleen tyrosine kinase (SYK) 525/526 protein found in the blood of patients with lymphoma.. [ Time Frame: First 29 days ]
    Evaluate the effect of ASN002 on biomarkers

  4. To evaluate the change from baseline in the intensity of Phospho-extracellular signal-regulated kinases (ERK) protein found in the blood of patients with lymphoma. [ Time Frame: First 29 days ]
    Evaluate the effect of ASN002 on biomarkers

  5. The number of patients who show a decrease from baseline in a serum panel of biomarkers of inflammation [ Time Frame: First 29 days ]
    Evaluate the effect of ASN002 on biomarkers



Information from the National Library of Medicine

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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:

  • 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.

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): NCT02440685


Locations
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United States, Arizona
Arizona Oncology
Tempe, Arizona, United States, 85206
United States, California
University of California, San Francisco
San Francisco, California, United States, 94122
United States, Georgia
Winship Cancer Institute - Emory
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
START - Midwest
Grand Rapids, Michigan, United States, 49503
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Argentina
Hospital Universitario Austral
Buenos Aires, Derqui, Pilar, Argentina, 1629
Instituto Alexander Fleming
Ciudad Autonoma de Buenos Aires, Argentina, 1426
Sponsors and Collaborators
Asana BioSciences
Investigators
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Study Director: Niranjan Rao, PhD Asana BioSciences

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Responsible Party: Asana BioSciences
ClinicalTrials.gov Identifier: NCT02440685     History of Changes
Other Study ID Numbers: ASN002-101
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Asana BioSciences:
DLBCL
FL
MCL
PTCL
MF
CLL
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Leukemia, B-Cell
Primary Myelofibrosis
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
Pathologic Processes