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| Name | Class |
|---|---|
| EOC Pharma | INDUSTRY |
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This is a phase II, single arm, open-label study of two parallel cohorts (advanced stomach and gastroesophageal junction cancer and hepatocellular carcinoma), evaluating the effects of telatinib in combination with Keytruda on progression-free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| telatinib + Keytruda | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telatinib | Drug | 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Duration of time from start of treatment until progression or death, whichever comes first | through study completion, approximately 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | The percentage of patients who have a partial or complete response to treatment | from the start of treatment until the end of treatment, approximately 12 months |
| Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Hendifar, MD, MPH | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CS Cancer Beverly Hills | Beverly Hills | California | 90211 | United States | ||
| CS Cancer at The Angeles Clinic and Research Institute |
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The trial opened to accrual on 7/12/2021 with first subject enrolled on study 7/28/2021. A total of 23 patients consented; 5 subjects failed screening; 2 were withdrawn; 16 subjects went on treatment, 1 subject (subject 009) withdrew consent; 15 completed study intervention evaluable. The study was closed to accrual on 02/07/2023 due to discontinuation of support by the drug supplier and funding source, due to postulated limited potential utility of the study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | telatinib + Keytruda | Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent Single Arm with 2 Cohorts: Cohort 1: Gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy. Cohort 2: Hepatocellular carcinoma, with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2023 |
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| Keytruda | Drug | 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent |
|
|
The percentage of patients who have stable disease, partial response, or complete response to treatment
| from the start of treatment until the end of treatment, approximately 12 months |
| Overall Survival | The length of time from the start of treatment that patients are still alive | from the start of treatment until time-of-event |
| Number and Severity of Adverse Events | Incidence and severity of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 | from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first), approximately 13 months |
| Los Angeles |
| California |
| 90025 |
| United States |
| CS Cancer at the Samuel Oschin Cancer Center | Los Angeles | California | 90048 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telatinib + Keytruda | Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent Single Arm with 2 Cohorts: Cohort 1: Gastric/esophagealgastric adenocarcinoma, recurrent, locally advanced or metastatic, PD-L1-positive disease (CPS ≥1), progressed on at least two prior lines of therapy and/or discontinued second line therapy for intolerance, indicated for Keytruda therapy. Cohort 2: Hepatocellular carcinoma, with diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases criteria for patients with cirrhosis, unresectable disease not amenable to locoregional therapy with disease progression after at least one prior line of systemic therapy or discontinued first line therapy for intolerance. |
| 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 | 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 |
| ||||||||||||||||||||
| 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 | Progression-free Survival | Duration of time from start of treatment until progression or death, whichever comes first | Posted | Mean | Standard Deviation | Days | through study completion, approximately 2.5 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Response Rate | The percentage of patients who have a partial or complete response to treatment | Posted | Count of Participants | Participants | from the start of treatment until the end of treatment, approximately 12 months |
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| ||||||||||||||||||||||||||||
| Secondary | Disease Control Rate | The percentage of patients who have stable disease, partial response, or complete response to treatment | Posted | Count of Participants | Participants | from the start of treatment until the end of treatment, approximately 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | The length of time from the start of treatment that patients are still alive | Posted | Median | 95% Confidence Interval | days | from the start of treatment until time-of-event |
|
| |||||||||||||||||||||||||||
| Secondary | Number and Severity of Adverse Events | Incidence and severity of adverse events as measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 | Posted | Count of Units | Adverse Events (AEs) | from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first), approximately 13 months | Adverse Events (AEs) | Adverse Events (AEs) |
|
|
approximately 13 months
All patients experiencing an AE will be monitored until: the AE resolves or the symptoms or signs that constitute the AE return to baseline, any abnormal laboratory value deemed an AE, has returned to baseline, there is a satisfactory explanation other than the study drug for the changes observed, death, or until 30 days following last dose of study drug or until initiation of a new anticancer therapy (whichever occurs first)
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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 | telatinib + Keytruda | Telatinib: 900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent Keytruda: 200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent | 12 | 16 | 8 | 16 | 16 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Biliary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Lung Infection | Infections and infestations | Systematic Assessment |
| ||
| Other | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Alanine Aminotransferase | Investigations | Systematic Assessment |
| ||
| Alkaline Phosphatase Increased | Investigations | Systematic Assessment |
| ||
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anal Fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asparate Aminotransferase Increased | Investigations | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
| ||
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Buttock Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Chest Pain- Cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Conjunctivitis | Infections and infestations | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Creatinine Increased | Investigations | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnea | Renal and urinary disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Edema Face | General disorders | Systematic Assessment |
| ||
| Edema Limbs | General disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Eye Disorders- Other, Specify | Eye disorders | Systematic Assessment |
| ||
| Eye Pain | Eye disorders | Systematic Assessment |
| ||
| Facial Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Gait Disturbance | General disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| General Disorders and Administration Site Conditions - Other, Specify | General disorders | Systematic Assessment |
| ||
| General Disorders and Administration Site Conditions - Other, Specify | Gastrointestinal disorders | Systematic Assessment |
| ||
| Generalized Edema | General disorders | Systematic Assessment |
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| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Genital Edema | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
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| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hip Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hoarseness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Localized Edema | General disorders | Systematic Assessment |
| ||
| Mucositis Oral | Gastrointestinal disorders | Systematic Assessment |
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| Muscle Cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorder - other, specify | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Investigations | Systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neutrophil Count Decreased | Investigations | Systematic Assessment |
| ||
| Other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Other | Eye disorders | Systematic Assessment |
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| Other | Investigations | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Papulopustular Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pelvic Pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Periorbital Edema | Eye disorders | Systematic Assessment |
| ||
| Platelet Count Decreased | Investigations | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash Acneiform | 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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| Rectal Fissure | Gastrointestinal disorders | Systematic Assessment |
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| Rectal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Renal and Urinary Disorders - Other, specify | Renal and urinary disorders | Systematic Assessment |
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| Skin Infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin Infection | Infections and infestations | Systematic Assessment |
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| Sleep Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Stomach Pain | Gastrointestinal disorders | Systematic Assessment |
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| Thrush | Infections and infestations | Systematic Assessment |
| ||
| Upper Gastrointestinal Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Vaginal Infection | Infections and infestations | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Weight Loss | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Hendifar, MD, MPH | Cedars-Sinai Medical Center | 3104232217 | andrew.hendifar@cshs.org |
| May 30, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2021 | May 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C533371 | telatinib |
| C582435 | pembrolizumab |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Adverse Events (AEs) |
|
|