Trial Outcomes & Findings for A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST) (NCT NCT04282980)

Last Updated: 2025-03-03

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Approximately 10 months since the first subject enrolled.

Results posted on

2025-03-03

Participant Flow

Between April 2020 and August 2020, 39 patients were enrolled, and all received at least one dose of study drug.

50 patients were assessed for eligibility, 11 experienced screen failure.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	39
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Remained on treatment	6
Overall Study Survival follow-up	11
Overall Study Withdrawal of informed consent	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Study of DCC-2618 (Ripretinib) In Patients With With Advanced Gastrointestinal Stromal Tumors (GIST)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DCC-2618 n=39 Participants DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	55.1 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	39 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	39 participants n=5 Participants
ECOG performance status 0	7 Participants n=5 Participants
ECOG performance status 1	28 Participants n=5 Participants
ECOG performance status 2	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 10 months since the first subject enrolled.

Population: 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).

Outcome measures

Outcome measures
Measure	DCC-2618 n=38 Participants DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor
Progression-Free Survival (PFS)	6.44 months Interval 2.89 to 8.31

SECONDARY outcome

Timeframe: Approximately 15 months since the first subject enrolled.

Population: 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).

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.

Outcome measures

Outcome measures
Measure	DCC-2618 n=38 Participants DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor
Objective Response Rate (ORR)	8 Participants

SECONDARY outcome

Timeframe: Approximately 28 months since the first subject enrolled.

Overall survival (OS) is defined as the time from the first dose of study drug to all-cause death.

Outcome measures

Outcome measures
Measure	DCC-2618 n=38 Participants DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor
Overall Survival (OS)	25.56 months Interval 11.73 to The upper limit of 95% confidence interval was not estimated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Approximately 15 months since the first subject enrolled.

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.

Outcome measures

Outcome measures
Measure	DCC-2618 n=8 Participants DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor
Time to Best Response (TBR)	2.25 months Interval 1.0 to 11.9

SECONDARY outcome

Timeframe: Approximately 15 months since the first subject enrolled.

Disease control rate (DCR) based on independent radiology review (confirmed CR + confirmed PR + SD for 12 weeks)

Outcome measures

Outcome measures
Measure	DCC-2618 n=38 Participants DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor
Disease Control Rate (DCR) (Confirmed CR + Confirmed PR + SD) for 12 Weeks	20 Participants

Adverse Events

DCC-2618

Serious events: 10 serious events

Other events: 39 other events

Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure	DCC-2618 n=39 participants at risk DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor
Gastrointestinal disorders Gastrointestinal haemorrhage	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Blood and lymphatic system disorders Anaemia	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
General disorders Pyrexia	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Cardiac disorders Cardiac dysfunction	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Renal and urinary disorders Acute kidney injury	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Abdominal pain upper	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Cardiac disorders Acute myocardiac infarction	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Infections and infestations Pneumonia	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Inra-abdomina fluid collection	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Aabdominal pain	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Abdominal distension	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Respiratory, thoracic and mediastinal disorders Interstitial lung desease	2.6% 1/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.

Other adverse events

Other adverse events
Measure	DCC-2618 n=39 participants at risk DCC-2618 drug is 50mg per tablet, 150mg once a day, with 28 days as a treatment cycle. DCC-2618: Oral kinase inhibitor
Blood and lymphatic system disorders Anaemia	66.7% 26/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Skin and subcutaneous tissue disorders Alopecia	43.6% 17/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
General disorders Asthenia	33.3% 13/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Bilirubin conjugated increased	33.3% 13/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood bilirubin increased	33.3% 13/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Weight decreased	25.6% 10/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Abdominal distension	23.1% 9/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Hypokalaemia	23.1% 9/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Musculoskeletal and connective tissue disorders Myalgia	23.1% 9/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	23.1% 9/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Constipation	20.5% 8/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Diarrhoea	20.5% 8/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Hyperglycaemia	20.5% 8/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Hypoalbuminaemia	20.5% 8/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Hypocalcaemia	20.5% 8/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Abdominal pain	17.9% 7/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood bilirubin unconjugated increased	17.9% 7/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood creatine phosphokinase increased	17.9% 7/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Cardiac disorders Sinus bradycardia	15.4% 6/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Vomiting	15.4% 6/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Gamma-glutamyltransferase increased	15.4% 6/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Lipase increased	15.4% 6/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations White blood cell count decreased	15.4% 6/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Hypophosphataemia	15.4% 6/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Musculoskeletal and connective tissue disorders Muscle spasms	15.4% 6/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Aspartate aminotransferase increased	12.8% 5/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood alkaline phosphatase increased	12.8% 5/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood creatinine increased	12.8% 5/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Decreased appetite	12.8% 5/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Nervous system disorders Headache	12.8% 5/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Renal and urinary disorders Proteinuria	12.8% 5/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Skin and subcutaneous tissue disorders Rash	12.8% 5/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Immune system disorders Contrast media allergy	10.3% 4/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Infections and infestations Urinary tract infection	10.3% 4/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Neutrophil count decreased	10.3% 4/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Urinary occult blood positive	10.3% 4/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Hypertriglyceridaemia	10.3% 4/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Hyponatraemia	10.3% 4/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Musculoskeletal and connective tissue disorders Arthralgia	10.3% 4/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Psychiatric disorders Insomnia	10.3% 4/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Skin and subcutaneous tissue disorders Pruritus	10.3% 4/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Cardiac disorders Arrhythmia	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Cardiac disorders Palpitations	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Cardiac disorders Supraventricular extrasystoles	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Endocrine disorders Hypothyroidism	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Eye disorders Xerophthalmia	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Abdominal pain upper	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Gingival bleeding	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Gastrointestinal disorders Nausea	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
General disorders Chest discomfort	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
General disorders Oedema peripheral	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
General disorders Pyrexia	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Hepatobiliary disorders Hepatic pain	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Infections and infestations Folliculitis	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Infections and infestations Upper respiratory tract infection	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Alanine aminotransferase increased	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Apolipoprotein A-I increased	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Apolipoprotein B increased	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood cholesterol increased	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood creatine phosphokinase MB increased	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood fibrinogen increased	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood glucose increased	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood lactate dehydrogenase increased	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Blood urea increased	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations C-reactive protein increased	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Coagulation test abnormal	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Glomerular filtration rate decreased	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations High density lipoprotein increased	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Low density lipoprotein increased	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Lymphocyte count decreased	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Neutrophil count increased	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Protein urine present	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations Red blood cells urine positive	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Investigations White blood cell count increased	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Hyperkalaemia	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Metabolism and nutrition disorders Hyperuricaemia	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Musculoskeletal and connective tissue disorders Pain in extremity	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Respiratory, thoracic and mediastinal disorders Productive cough	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Skin and subcutaneous tissue disorders Dermatitis	5.1% 2/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.
Vascular disorders Hypertension	7.7% 3/39 • From the date of the first dose of study treatment up to 30 days following study treatment discontinuation. Up to approximately 28 months.

Additional Information

Medical Director

Zai Lab

Phone: +86 4008201022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place