Trial Outcomes & Findings for Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer (NCT NCT03592641)
NCT ID: NCT03592641
Last Updated: 2023-10-17
Results Overview
Objective response rate is calculated as the number of people with a complete or partial response divided by the total number of people treated. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
From start of treatment until documented progression of disease (up to 4 months)
Results posted on
2023-10-17
Participant Flow
Recruitment occurred at 12 health system organizations within the NCI network. Enrollment was open from 1/30/2019 to 12/30/2021.
70 subjects were pre-screened to test for MET amplification. 9 subjects had MET amplification and signed the main consent form. 4 of these subjects were excluded from the trial because they did not meet all eligibility criteria. 5 subjects were enrolled in the treatment portion of the study.
Participant milestones
| Measure |
Treatment (Savolitinib)
savolitinib 600 mg once daily for weight ≥ 50 kg and 400 mg once daily for weight \< 50 kg
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Savolitinib)
savolitinib 600 mg once daily for weight ≥ 50 kg and 400 mg once daily for weight \< 50 kg
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Savolitinib)
n=5 Participants
savolitinib 600 mg once daily for weight ≥ 50 kg and 400 mg once daily for weight \< 50 kg
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until documented progression of disease (up to 4 months)Objective response rate is calculated as the number of people with a complete or partial response divided by the total number of people treated. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Treatment (Savolitinib)
n=4 Participants
savolitinib 600 mg once daily for weight ≥ 50 kg and 400 mg once daily for weight \< 50 kg
|
|---|---|
|
Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of treatment until documented progression of disease (up to 4 months)Progression-free survival is defined as the duration of time from start of treatment until clinical or radiographic progression or death, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Treatment (Savolitinib)
n=4 Participants
savolitinib 600 mg once daily for weight ≥ 50 kg and 400 mg once daily for weight \< 50 kg
|
|---|---|
|
Months of Progression-Free Survival (PFS)
|
2.29 months
Interval 1.41 to 3.55
|
Adverse Events
Treatment (Savolitinib)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Savolitinib)
n=5 participants at risk
savolitinib 600 mg once daily for weight ≥ 50 kg and 400 mg once daily for weight \< 50 kg
|
|---|---|
|
Metabolism and nutrition disorders
anorexia
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Nervous system disorders
dizziness
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Cardiac disorders
sinus tachycardia
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Vascular disorders
thromboembolic event
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
General disorders
edema limbs
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Injury, poisoning and procedural complications
vascular access complication
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
Other adverse events
| Measure |
Treatment (Savolitinib)
n=5 participants at risk
savolitinib 600 mg once daily for weight ≥ 50 kg and 400 mg once daily for weight \< 50 kg
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Investigations
Alkaline phosphatase increased
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Gastrointestinal disorders
Ascites
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Investigations
Blood bicarbonate decreased
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Investigations
Blood lactate dehydrogenase increased
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
General disorders
Fatigue
|
60.0%
3/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Gastrointestinal disorders
Indigestion
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Hepatobiliary disorders
Biliary Obstructions
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Vascular disorders
Hypertension
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Infections and infestations
Common Cold Symptoms
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Injury, poisoning and procedural complications
Stubbed Toe
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Investigations
LDH Increased
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
General disorders
Pain
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Investigations
Serum amylase increased
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
1/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
Investigations
White blood cell decreased
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
General disorders
Edema limbs
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
|
General disorders
Non-cardiac chest pain
|
40.0%
2/5 • From start of treatment until 1 month after end of treatment (up to 5 months)
Adverse events were described by grade, frequency, and attribution according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60