Trial Outcomes & Findings for TAS-OX for Refractory Metastatic Colon Cancer (NCT NCT02848079)
NCT ID: NCT02848079
Last Updated: 2021-07-20
Results Overview
Overall Response Rate was measured by Response Evaluation Criteria In Solid Tumor (RECIST) 1.1 criteria. Tumors were assessed with CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
up to 30 days following discontinuation of treatment
Results posted on
2021-07-20
Participant Flow
Participant milestones
| Measure |
Combined TAS-102 and TAS-OX
Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion. In Part 1 treatments were started at level 1 doses, which were based on prior clinical experience with the medications studied. Dose escalation followed a traditional "3+3" design. The subjects in Part 2 were treated with dose level 3.
Oxaliplatin infusion was given on day 1 of each cycle. TAS-102 was taken twice daily on days 1-5 of each cycle.
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|---|---|
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Overall Study
STARTED
|
41
|
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Overall Study
Receieved Study Treatment
|
41
|
|
Overall Study
Discontinued
|
41
|
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Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TAS-OX for Refractory Metastatic Colon Cancer
Baseline characteristics by cohort
| Measure |
Combined TAS-102 and TAS-OX
n=41 Participants
Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
|
|---|---|
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Age, Customized
|
62 years
n=93 Participants
|
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Sex: Female, Male
Female
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15 Participants
n=93 Participants
|
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Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
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Race/Ethnicity, Customized
White
|
38 Participants
n=93 Participants
|
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Race/Ethnicity, Customized
Black
|
1 Participants
n=93 Participants
|
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Race/Ethnicity, Customized
Asian
|
2 Participants
n=93 Participants
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ECOG
0
|
25 Participants
n=93 Participants
|
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ECOG
1
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16 Participants
n=93 Participants
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Location of primary tumor, No.
Left side of colon, including rectum
|
31 Participants
n=93 Participants
|
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Location of primary tumor, No.
Right side of colon
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10 Participants
n=93 Participants
|
|
Stage at diagnosis
I
|
1 Participants
n=93 Participants
|
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Stage at diagnosis
II
|
2 Participants
n=93 Participants
|
|
Stage at diagnosis
III
|
13 Participants
n=93 Participants
|
|
Stage at diagnosis
IV
|
25 Participants
n=93 Participants
|
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Histology
Well-differentiated
|
2 Participants
n=93 Participants
|
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Histology
Moderately differentiated
|
30 Participants
n=93 Participants
|
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Histology
Poorly differentiated
|
9 Participants
n=93 Participants
|
|
High microsatellite instability
|
2 Participants
n=93 Participants
|
|
KRAS/BRAF mutation
KRAS mutation
|
20 Participants
n=93 Participants
|
|
KRAS/BRAF mutation
BRAF mutation
|
1 Participants
n=93 Participants
|
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KRAS/BRAF mutation
Wild type
|
20 Participants
n=93 Participants
|
|
Number of prior therapies
1 therapy
|
1 Participants
n=93 Participants
|
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Number of prior therapies
2 therapies
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18 Participants
n=93 Participants
|
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Number of prior therapies
3 therapies
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15 Participants
n=93 Participants
|
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Number of prior therapies
≥ 4 therapies
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7 Participants
n=93 Participants
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Progression during prior oxaliplatin
Yes
|
18 Participants
n=93 Participants
|
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Progression during prior oxaliplatin
No
|
23 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 30 days following discontinuation of treatmentPopulation: Intention-to-treat (ITT)
Overall Response Rate was measured by Response Evaluation Criteria In Solid Tumor (RECIST) 1.1 criteria. Tumors were assessed with CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
Outcome measures
| Measure |
Combined TAS-102 and TAS-OX
n=41 Participants
Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
|
|---|---|
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Overall Response Rate
|
2.4 months
Interval 0.0 to 12.9
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SECONDARY outcome
Timeframe: from the date of start of treatment to the date of first documented progression or any cause of death assessed up to 12 months.Population: Intention-to-treat (ITT)
Progression Free Survival was assessed according to RECIST criteria version 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Combined TAS-102 and TAS-OX
n=41 Participants
Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
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|---|---|
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Progression Free Survival
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2.7 months
Interval 2.4 to 4.8
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SECONDARY outcome
Timeframe: from the date of start of treatment to the date of any cause of death assessed up to 24 months.Population: Intention-to-Treat (ITT)
Overall Survival was assessed by the time to death from start of study.
Outcome measures
| Measure |
Combined TAS-102 and TAS-OX
n=41 Participants
Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
|
|---|---|
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Overall Survival
|
6.8 months
Interval 5.4 to 10.0
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Adverse Events
Combined TAS-102 and TAS-OX
Serious events: 8 serious events
Other events: 41 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
Combined TAS-102 and TAS-OX
n=41 participants at risk
Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
|
|---|---|
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General disorders
Fever
|
2.4%
1/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
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Injury, poisoning and procedural complications
Fracture
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2.4%
1/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
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General disorders
General disorders and administration site conditions - Other, specify
|
2.4%
1/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.4%
1/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.4%
1/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
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Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.4%
1/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.4%
1/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Vascular disorders
Thromboembolic event
|
4.9%
2/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
Other adverse events
| Measure |
Combined TAS-102 and TAS-OX
n=41 participants at risk
Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
36.6%
15/41 • Number of events 49 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Gastrointestinal disorders
Nausea
|
53.7%
22/41 • Number of events 39 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
General disorders
Pain
|
7.3%
3/41 • Number of events 5 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Nervous system disorders
Paresthesia
|
19.5%
8/41 • Number of events 13 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.6%
6/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Investigations
Platelet count decreased
|
41.5%
17/41 • Number of events 59 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Gastrointestinal disorders
Diarrhea
|
31.7%
13/41 • Number of events 24 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Gastrointestinal disorders
Vomiting
|
29.3%
12/41 • Number of events 20 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
General disorders
Anorexia
|
39.0%
16/41 • Number of events 21 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Blood and lymphatic system disorders
Anemia
|
61.0%
25/41 • Number of events 46 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Investigations
Neutrophil count decrease
|
36.6%
15/41 • Number of events 49 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Blood and lymphatic system disorders
Platelet count decrease
|
31.7%
13/41 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Investigations
White blood cell decreased
|
34.1%
14/41 • Number of events 51 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Blood and lymphatic system disorders
Alkaline phosphatase increased
|
48.8%
20/41 • Number of events 28 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Gastrointestinal disorders
Abdominal Pain
|
26.8%
11/41 • Number of events 14 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Investigations
Alanine aminotransferase increased
|
22.0%
9/41 • Number of events 12 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Investigations
Aspartate aminotransferase increased
|
34.1%
14/41 • Number of events 22 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.3%
3/41 • Number of events 3 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
19.5%
8/41 • Number of events 24 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Investigations
Blood bilirubin increased
|
24.4%
10/41 • Number of events 22 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Gastrointestinal disorders
Constipation
|
26.8%
11/41 • Number of events 19 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.0%
9/41 • Number of events 12 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Investigations
Creatinine increased
|
7.3%
3/41 • Number of events 3 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Nervous system disorders
Dizziness
|
14.6%
6/41 • Number of events 7 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Nervous system disorders
Dysgeusia
|
17.1%
7/41 • Number of events 7 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.5%
8/41 • Number of events 9 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
General disorders
Fatigue
|
65.9%
27/41 • Number of events 48 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
General disorders
Fever
|
9.8%
4/41 • Number of events 6 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
3/41 • Number of events 3 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Nervous system disorders
Headache
|
7.3%
3/41 • Number of events 3 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Vascular disorders
Hypertension
|
29.3%
12/41 • Number of events 23 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
26.8%
11/41 • Number of events 17 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.1%
7/41 • Number of events 8 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.1%
7/41 • Number of events 9 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
29.3%
12/41 • Number of events 17 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.2%
5/41 • Number of events 7 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Investigations
INR increased
|
9.8%
4/41 • Number of events 11 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Psychiatric disorders
Insomnia
|
17.1%
7/41 • Number of events 9 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Infections and infestations
Sinusitis
|
7.3%
3/41 • Number of events 3 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
7.3%
3/41 • Number of events 3 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
Investigations
Weight Loss
|
9.8%
4/41 • Number of events 5 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
General disorders
Edema limbs
|
14.6%
6/41 • Number of events 8 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
|
General disorders
Infusion related reaction
|
7.3%
3/41 • Number of events 3 • up to 38 months
The reported AEs here are all AEs in the study, regardless of attribution. Whereas in the published manuscript, SAE's were reported when they could be attributed to treatment and that a 10% threshold was used in reporting AE's.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place