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Spots Global Cancer Trial Database for A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors

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Trial Identification

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

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

Study ID: NCT02440685

Study Description

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.

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Arizona Oncology, Tempe, Arizona, United States

University of California, San Francisco, San Francisco, California, United States

Winship Cancer Institute - Emory, Atlanta, Georgia, United States

University of Michigan, Ann Arbor, Michigan, United States

START - Midwest, Grand Rapids, Michigan, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Gabrail Cancer Center, Canton, Ohio, United States

Oregon Health & Science University, Portland, Oregon, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center, Houston, Texas, United States

South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States

Virginia Cancer Specialists, Fairfax, Virginia, United States

Hospital Universitario Austral, Buenos Aires, Derqui, Pilar, Argentina

Instituto Alexander Fleming, Ciudad Autonoma de Buenos Aires, , Argentina

Contact Details

Name: Niranjan Rao, PhD

Affiliation: Asana BioSciences

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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