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To assess the anti-tumor activity and safety of Tenalisib in patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma (iNHL),
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenalisib | Experimental | Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenalisib, | Drug | BID, Orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as sum of CR and PR rates and will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of Non-Hodgkin lymphoma. (Cheson-2014) | 7 months |
| Complete Response Rate | CR rate will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of non-Hodgkin lymphoma. | 7 months |
| Progression Free Survival (PFS) | PFS is defined as the time of the first dose of Tenalisib to disease progression or death. | From date of first dose of tenalisib until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months |
| Duration of Response (DoR) | DoR is measured from the initial response to disease progression or death | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability of Tenalisib | 8 months |
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Inclusion Criteria:
Patients with histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to:
Relapsed or refractory after ≥ 2 prior lines of therapy (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen). Patients must have received rituximab and alkylating agents.
Patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) with the longest diameter ≥ 1.5 cm.
Male or female patients > 18 years of age.
ECOG performance status ≤ 2.
Life expectancy of at least 3 months.
Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:
Use of an effective means of contraception for female patients of child-bearing potential, and all male partners.
Willingness and ability to comply with trial and follow-up procedures, give written informed consent.
Exclusion Criteria:
FL grade 3b or transformed disease or CLL
Cancer therapy within 3 weeks (21 days) or 5 half-lives (whichever is shorter) prior to C1D1. Corticosteroids (prednisone or equivalent) at a dose of < 20 mg daily are allowed. Corticosteroid should be stabilized for at least 1 week prior to C1D1
Auto-SCT within 3 months from C1D1 (patients must not have active graft versus- host disease)
History of having received an Allo-SCT
Active hepatitis B or C infection
Known history of human immunodeficiency virus (HIV) infection
Evidence of ongoing severe systemic bacterial, fungal or viral infection
Known primary central nervous system lymphoma or any preexisting neurologic manifestations
Known history of drug-induced liver injury, alcoholic liver disease, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension;
Prior exposure to drug that specifically inhibits PI3K
Pregnancy or lactation
Myeloid growth factors or red blood cells/ platelet transfusion within 14 days prior to C1D1
Drug administration within 1 week prior to C1D1
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | United States | ||
| Colorado Blood Cancer Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tenalisib | Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles Tenalisib,: BID, Orally |
| 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 | Dec 4, 2018 | Jun 29, 2021 |
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| Denver |
| Colorado |
| 80218 |
| United States |
| Florida cancer specialists & Research Institute | Florida City | Florida | 33401 | United States |
| Florida Cancer Specialist/ South | Fort Myers | Florida | 33908 | United States |
| Florida Cancer Specialists/North | St. Petersburg | Florida | 33705 | United States |
| HCA Midwest Health Kansas City | Kansas City | Missouri | 64132 | United States |
| Tennessee Oncology | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Blacktown Hospital, Blacktown Cancer and Haematology Center | Blacktown | New South Wales | 2148 | Australia |
| Brisbane Clinic for Lymphoma, Myeloma and Leukaemia, | Greenslopes | Queensland | 4120 | Australia |
| John Flynn Private Hospital, | Tugun | Queensland | 4224 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tenalisib | Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles Tenalisib,: BID, Orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 (ORR) | ORR is defined as sum of CR and PR rates and will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of Non-Hodgkin lymphoma. (Cheson-2014) | Patients who received at least 1 dose of study medication and provided at least 1 post-baseline efficacy assessment | Posted | Number | 95% Confidence Interval | Percent of participants | 7 months |
|
|
| |||||||||||||||||||||||||
| Primary | Complete Response Rate | CR rate will be assessed according to the Lugano Classification for initial evaluation, staging, and response assessment of non-Hodgkin lymphoma. | Patients who received at least 1 dose of study medication and provided at least 1 post-baseline efficacy assessment | Posted | Number | 95% Confidence Interval | Percent of participants | 7 months |
|
| ||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) | PFS is defined as the time of the first dose of Tenalisib to disease progression or death. | Patients who received at least 1 dose of study medication and provide at least 1 post-baseline efficacy assessment | Posted | Median | 95% Confidence Interval | days | From date of first dose of tenalisib until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months |
|
| ||||||||||||||||||||||||||
| Primary | Duration of Response (DoR) | DoR is measured from the initial response to disease progression or death | Patients who received at least 1 dose of study medication and provide at least 1 post-baseline efficacy assessment | Posted | Number | days | 7 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v4.0 | Safety and tolerability of Tenalisib | Patients who received at least 1 dose of study medication | Posted | Number | participants | 8 months |
|
|
8 months
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients were monitored for adverse events and both related and as well as non-related adverse events were captured during the study. All adverse events (irrespective of causality) are reported here.
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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 | Tenalisib | Participants receive Tenalisib 800 mg BID in 28-Days Cycle for 8 Cycles Tenalisib,: BID, Orally | 0 | 20 | 3 | 20 | 13 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
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| Neutrophil Count Decreased | Investigations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Allergy to arthropod bite | Immune system disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | Systematic Assessment |
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| Fungal infection | Infections and infestations | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | Systematic Assessment |
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| Serratia infection | Infections and infestations | Systematic Assessment |
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| Viral infection | Infections and infestations | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Neurological symptoms | Nervous system disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tachypnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash generalized | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prajak Barde MD | Rhizen Pharmaceuticals | +41325800175 | pjb@rhizen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2020 | Jul 20, 2021 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000706530 | tenalisib |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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