Trial Outcomes & Findings for A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib (NCT NCT04633122)

Last Updated: 2025-02-10

Results Overview

PFS is defined as the time interval from randomization to the first occurrence of progressive disease based on assessment of the independent radiology review (IRR) or death due to any causes.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

108 participants

Primary outcome timeframe

Approximately 12 months.

Results posted on

2025-02-10

Participant Flow

108 patients were randomized.

Participant milestones

Participant milestones
Measure	Ripretinib 50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. Ripretinib: Oral kinase inhibitor	Sunitinib 12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. Sunitinib: second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
Overall Study STARTED	54	54
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	41	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Ripretinib 50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. Ripretinib: Oral kinase inhibitor	Sunitinib 12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. Sunitinib: second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
Overall Study Remained on treatment	19	14
Overall Study Survival follow-up stopped	22	25

Baseline Characteristics

A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ripretinib n=54 Participants 50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. Ripretinib: Oral kinase inhibitor	Sunitinib n=54 Participants 12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. Sunitinib: second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	39 Participants n=7 Participants	74 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Age, Continuous	59 years n=5 Participants	58.5 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 12 months.

PFS is defined as the time interval from randomization to the first occurrence of progressive disease based on assessment of the independent radiology review (IRR) or death due to any causes.

Outcome measures

Outcome measures
Measure	Ripretinib n=54 Participants 50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. Ripretinib: Oral kinase inhibitor	Sunitinib n=54 Participants 12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. Sunitinib: second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
Progression-free Survival (PFS)	10.3 months Interval 5.5 to The upper limit of 95% CI was not evaluable due to low PFS maturity.	8.3 months Interval 4.9 to The upper limit of 95% CI was not evaluable due to low PFS maturity.

SECONDARY outcome

Timeframe: Approximately 12 months.

The percentage of participants whose efficacy is confirmed as complete response (CR) or partial responses (PR) based on independent radiology review.

Outcome measures

Outcome measures
Measure	Ripretinib n=54 Participants 50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. Ripretinib: Oral kinase inhibitor	Sunitinib n=54 Participants 12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. Sunitinib: second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
Objective Response Rate (ORR)	16 Participants	11 Participants

SECONDARY outcome

Timeframe: Approximately 12 months.

The percentage of participants whose efficacy is confirmed as complete response (CR) or partial responses (PR) or duration of SD ≥ 12 months based on independent radiology review.

Outcome measures

Outcome measures
Measure	Ripretinib n=54 Participants 50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. Ripretinib: Oral kinase inhibitor	Sunitinib n=54 Participants 12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. Sunitinib: second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
Disease Control Rate (DCR)	24 Participants	20 Participants

Adverse Events

Ripretinib

Serious events: 9 serious events

Other events: 54 other events

Deaths: 13 deaths

Sunitinib

Serious events: 12 serious events

Other events: 54 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

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

Measure	Ripretinib n=54 participants at risk 50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. Ripretinib: Oral kinase inhibitor	Sunitinib n=54 participants at risk 12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. Sunitinib: second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
Gastrointestinal disorders Gastrointestinal Haemorrhage	5.6% 3/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	3.7% 2/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Gastrointestinal disorders Intestinal obstruction	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Blood and lymphatic system disorders Anaemia	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Hepatobiliary disorders Cholecystitis	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Nervous system disorders Hypoaesthesia	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Musculoskeletal and connective tissue disorders Muscular weakness	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Infections and infestations Pneumonia	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
General disorders Pyrexia	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	3.7% 2/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	3.7% 2/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Gastrointestinal disorders Abdominal pain	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Nervous system disorders Cerebral haemorrhage	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Hepatobiliary disorders Hepatic failure	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Infections and infestations Liver abscess	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Renal and urinary disorders Renal failure	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Infections and infestations Sepsis	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.	1.9% 1/54 • Approximately 12 months. An AE is defined as any untoward medical occurrence in a patient administered a pharmaceutical product during the study, which does not necessarily have a causal relationship with the study drug. This includes any newly occurring event or previous condition that has increased in severity or frequency after the ICF is signed.