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Business decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A ASN002 Dose Escalation | Experimental | Multiple ascending doses of ASN002 will be administered to determine the maximum tolerated dose (MTD). Arm Closed |
|
| Part B ASN002 Recommended dose (RD) | Experimental | ASN002 administered at the recommended dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASN002 Dose Escalation | Drug | Multiple ascending doses of ASN002 assigned by cohort |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Due to the early termination of the study, data for efficacy endpoints were insufficient for the planned efficacy analyses. | First 29 days |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Niranjan Rao, PhD | Asana BioSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology | Tempe | Arizona | 85284 | United States | ||
| University of California, San Francisco |
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 mg BID | ASN002 Dose 10 mg BID |
| FG001 | 20 mg BID | ASN002 20 mg BID |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2017 | Apr 13, 2023 |
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Study terminated early so no all groups per protocol were conducted
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| ASN002 RD | Drug | Recommended dose of ASN002 from Part A |
|
| San Francisco |
| California |
| 94143 |
| United States |
| Winship Cancer Institute - Emory | Atlanta | Georgia | 30322 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| START - Midwest | Grand Rapids | Michigan | 49546 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Hospital Universitario Austral | Buenos Aires | Derqui, Pilar | 1629 | Argentina |
| Instituto Alexander Fleming | Buenos Aires | 1426 | Argentina |
| 30 mg BID |
ASN002 30 mg BID |
| FG003 | 40 mg BID | ASN002 40 mg BID |
| FG004 | 50 mg BID | ASN002 50 mg BID |
| FG005 | 75 mg BID | ASN002 75 mg BID |
| FG006 | 100 mg BID | ASN002 100 mg BID |
| FG007 | 80 mg QD | ASN002 80 mg QD |
| FG008 | 120 mg QD | ASN002 120 mg QD |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg BID | ASN002 10 mg BID |
| BG001 | 20 mg BID | ASN002 20 mg BID |
| BG002 | 30 mg BID | ASN002 30 mg BID |
| BG003 | 40 mg BID | ASN002 40 mg BID |
| BG004 | 50 mg BID | ASN002 50 mg BID |
| BG005 | 75 mg BID | ASN002 75 mg BID |
| BG006 | 100 mg BID | ASN002 100 mg BID |
| BG007 | 80 mg QD | ASN002 80 mg QD |
| BG008 | 120 mg QD | ASN002 120 mg QD |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Disease Characteristic | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate | Due to the early termination of the study, data for efficacy endpoints were insufficient for the planned efficacy analyses. | Posted | Count of Participants | Participants | First 29 days |
|
|
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Days of duration ranged from 4 days to 280 days before early termination of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 mg BID | ASN002 10 mg BID | 0 | 3 | 1 | 3 | 3 | 3 |
| EG001 | 20 mg BID | ASN002 20 mg BID | 1 | 4 | 2 | 4 | 4 | 4 |
| EG002 | 30 mg BID | ASN002 30 mg BID | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | 40 mg BID | ASN002 40 mg BID | 1 | 4 | 2 | 4 | 4 | 4 |
| EG004 | 50 mg BID | ASN002 50 mg BID | 2 | 7 | 5 | 7 | 6 | 7 |
| EG005 | 75 mg BID | ASN002 75 mg BID | 6 | 15 | 10 | 15 | 14 | 15 |
| EG006 | 100 mg BID | ASN002 100 mg BID | 2 | 5 | 4 | 5 | 5 | 5 |
| EG007 | 80 mg QD | ASN002 80 mg QD | 0 | 7 | 4 | 7 | 7 | 7 |
| EG008 | 120 mg QD | ASN002 120 mg QD | 0 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumococcal bacteraemia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Blood creatinine increase | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Arthralagia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niranjan Rao | Libertas BioSciences | 908-872-1133 | niranjan@libertasbiosciences.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2017 | May 9, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D009369 | Neoplasms |
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D055728 | Primary Myelofibrosis |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D016399 | Lymphoma, T-Cell |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Solid tumor |
|
| Myelofibrosis |
|
| Complete response |
|
| Partial response |
|
| Stable disease |
|
| Progressive disease |
|