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The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review.
The primary objective of this trial is to evaluate the progress free survival (PFS) of DCC-2618 in patients with advanced gastrointestinal stromal tumors who have progressed with prior anticancer therapies based on independent radiologic review. This study enrolled 39 subjects of 9 sites in China mainland, and all enrolled subjects received DCC-2618 after enrollment as treatment.
The study used EDC to collect patient data and IRT system for patient randomization, using Imaging Endpoints as the central image to evaluate the PFS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCC-2618 | Experimental | DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCC-2618 | Drug | Oral kinase inhibitor |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) is defined as the time from the first dose of study drug to the first occurrence of disease progression based on independent radiology review or death due to any cause (whichever occurred first). | Approximately 10 months since the first subject enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The objective response rate (ORR) is defined as the percentage of participants who achieved confirmed complete response (CR) or partial responses (PR) based on independent radiology review. | Approximately 15 months since the first subject enrolled. |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zai Lab | Zai Lab (Shanghai) Co., Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | China | |||
| Chinese People's Liberation Army General Hospital |
50 patients were assessed for eligibility, 11 experienced screen failure.
Between April 2020 and August 2020, 39 patients were enrolled, and all received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | DCC-2618 | DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | DCC-2618 | DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor |
| 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 |
| 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 (PFS) | Progression-Free Survival (PFS) is defined as the time from the first dose of study drug to the first occurrence of disease progression based on independent radiology review or death due to any cause (whichever occurred first). | Efficacy analyses were performed using the efficacy analysis set (EAS), consisting of the 38 participants who had received continuous ripretinib treatment since C1D1. 1 subject discontinued treatment due to clinical progression during the intensive blood sampling period and a total of 38 subjects who entered treatment period (continuous dose period) were included in the Efficacy Analysis Set (EAS). | Posted | Median | 90% Confidence Interval | months | Approximately 10 months since the first subject enrolled. |
|
From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
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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 | DCC-2618 | DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Zai Lab | +86 4008201022 | Medinfo@zailaboratory.com |
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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 | Sep 14, 2020 | Oct 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707850 | ripretinib |
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Overall survival (OS) is defined as the time from the first dose of study drug to all-cause death. |
| Approximately 28 months since the first subject enrolled. |
| Time to Best Response (TBR) | Time to Best Response(TBR) based on independent radiology review is defined as the duration from the date of the first dose of the investigational drug to the date of confirming the best response. | Approximately 15 months since the first subject enrolled. |
| Disease Control Rate (DCR) (Confirmed CR + Confirmed PR + SD) for 12 Weeks | Disease control rate (DCR) based on independent radiology review (confirmed CR + confirmed PR + SD for 12 weeks) | Approximately 15 months since the first subject enrolled. |
| Beijing |
| Beijing Municipality |
| China |
| Union Medical College Hospital, Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Union Medical College Hospital, Fujian Medical University | Fuzhou | Fujian | China |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China |
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China |
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | China |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Lost to Follow-up |
|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ECOG performance status | Patients with lower ECOG scores tend to have a relatively better prognosis. | Count of Participants | Participants |
|
|
|
| Secondary | Objective Response Rate (ORR) | The objective response rate (ORR) is defined as the percentage of participants who achieved confirmed complete response (CR) or partial responses (PR) based on independent radiology review. | 1 subject discontinued treatment due to clinical progression during the intensive blood sampling period and a total of 38 subjects who entered treatment period (continuous dose period) were included in the Efficacy Analysis Set (EAS). | Posted | Count of Participants | Participants | Approximately 15 months since the first subject enrolled. |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival (OS) is defined as the time from the first dose of study drug to all-cause death. | 1 subject discontinued treatment due to clinical progression during the intensive blood sampling period and a total of 38 subjects who entered treatment period (continuous dose period) were included in the Efficacy Analysis Set (EAS). | Posted | Median | 95% Confidence Interval | months | Approximately 28 months since the first subject enrolled. |
|
|
|
| Secondary | Time to Best Response (TBR) | Time to Best Response(TBR) based on independent radiology review is defined as the duration from the date of the first dose of the investigational drug to the date of confirming the best response. | Posted | Median | Full Range | months | Approximately 15 months since the first subject enrolled. |
|
|
|
| Secondary | Disease Control Rate (DCR) (Confirmed CR + Confirmed PR + SD) for 12 Weeks | Disease control rate (DCR) based on independent radiology review (confirmed CR + confirmed PR + SD for 12 weeks) | 1 subject discontinued treatment due to clinical progression during the intensive blood sampling period and a total of 38 subjects who entered treatment period (continuous dose period) were included in the Efficacy Analysis Set (EAS). | Posted | Count of Participants | Participants | Approximately 15 months since the first subject enrolled. |
|
|
|
| 20 |
| 39 |
| 10 |
| 39 |
| 39 |
| 39 |
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Cardiac dysfunction | Cardiac disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Acute myocardiac infarction | Cardiac disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Inra-abdomina fluid collection | Gastrointestinal disorders | Systematic Assessment |
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| Aabdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Interstitial lung desease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Bilirubin conjugated increased | Investigations | Systematic Assessment |
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| Blood bilirubin increased | Investigations | Systematic Assessment |
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| Weight decreased | Investigations | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
|
| Lipase increased | Investigations | Systematic Assessment |
|
| White blood cell count decreased | Investigations | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Contrast media allergy | Immune system disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Urinary occult blood positive | Investigations | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Xerophthalmia | Eye disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Hepatic pain | Hepatobiliary disorders | Systematic Assessment |
|
| Folliculitis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Apolipoprotein A-I increased | Investigations | Systematic Assessment |
|
| Apolipoprotein B increased | Investigations | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | Systematic Assessment |
|
| Blood creatine phosphokinase MB increased | Investigations | Systematic Assessment |
|
| Blood fibrinogen increased | Investigations | Systematic Assessment |
|
| Blood glucose increased | Investigations | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | Systematic Assessment |
|
| Blood urea increased | Investigations | Systematic Assessment |
|
| C-reactive protein increased | Investigations | Systematic Assessment |
|
| Coagulation test abnormal | Investigations | Systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | Systematic Assessment |
|
| High density lipoprotein increased | Investigations | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | Systematic Assessment |
|
| Neutrophil count increased | Investigations | Systematic Assessment |
|
| Protein urine present | Investigations | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | Systematic Assessment |
|
| White blood cell count increased | Investigations | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |