Trial Outcomes & Findings for Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer (NCT NCT03981614)
NCT ID: NCT03981614
Last Updated: 2024-08-22
Results Overview
Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and will be documented at each enrolling site with no central review planned. PFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.05. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Time from randomization date to either disease progression or death from any cause, whichever occurs first, assessed for up to 16 months
Results posted on
2024-08-22
Participant Flow
Participant milestones
| Measure |
Arm A (Binimetinib, Palbociclib)
Patients receive binimetinib PO BID on days 1-28 and palbociclib PO QD on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\>
\>
\>
\>
\> Binimetinib: Given PO
\>
\>
\>
\>
\>
\> Palbociclib: Given PO
|
Arm B (Trifluridine and Tipiracil Hydrochloride)
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.
\>
\>
\>
\>
\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
Safety Run-In Cohort
In the safety run-in, an initial cohort will receive palbociclib orally once daily on days 1-21 out of a 28 day cycle and binimetinib orally twice per day continuously at 30 mg BID daily. The starting dose of palbociclib will be 100 mg orally once daily on days 1-21 out of a 28 day cycle. If the starting dose is not well tolerated, with 2 or more subjects experiencing excessive toxicity as defined in Section 7.15, then the dose will be reduced to 75 mg orally once daily on days 1-21 out of a 28 day cycle dose, and further de-escalation will be studied if needed to determine a safe and tolerable dose in this population of colorectal cancer patients.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
9
|
|
Overall Study
Crossed Over to Arm A
|
0
|
21
|
0
|
|
Overall Study
COMPLETED
|
42
|
41
|
8
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
1
|
Reasons for withdrawal
| Measure |
Arm A (Binimetinib, Palbociclib)
Patients receive binimetinib PO BID on days 1-28 and palbociclib PO QD on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
\>
\>
\>
\>
\>
\> Binimetinib: Given PO
\>
\>
\>
\>
\>
\> Palbociclib: Given PO
|
Arm B (Trifluridine and Tipiracil Hydrochloride)
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.
\>
\>
\>
\>
\>
\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
Safety Run-In Cohort
In the safety run-in, an initial cohort will receive palbociclib orally once daily on days 1-21 out of a 28 day cycle and binimetinib orally twice per day continuously at 30 mg BID daily. The starting dose of palbociclib will be 100 mg orally once daily on days 1-21 out of a 28 day cycle. If the starting dose is not well tolerated, with 2 or more subjects experiencing excessive toxicity as defined in Section 7.15, then the dose will be reduced to 75 mg orally once daily on days 1-21 out of a 28 day cycle dose, and further de-escalation will be studied if needed to determine a safe and tolerable dose in this population of colorectal cancer patients.
|
|---|---|---|---|
|
Overall Study
Patient withdrawn prior to treatment
|
5
|
5
|
1
|
Baseline Characteristics
Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Binimetinib, Palbociclib)
n=42 Participants
Patients receive binimetinib PO BID on days 1-28 and palbociclib PO QD on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\>\> \>\> Binimetinib: Given PO\>\>
\>\> Palbociclib: Given PO
|
Arm B (Trifluridine and Tipiracil Hydrochloride)
n=41 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\>\>
\>\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
Safety Run-In Cohort
n=8 Participants
In the safety run-in, an initial cohort will receive palbociclib orally once daily on days 1-21 out of a 28 day cycle and binimetinib orally twice per day continuously at 30 mg BID daily. The starting dose of palbociclib will be 100 mg orally once daily on days 1-21 out of a 28 day cycle. If the starting dose is not well tolerated, with 2 or more subjects experiencing excessive toxicity as defined in Section 7.15, then the dose will be reduced to 75 mg orally once daily on days 1-21 out of a 28 day cycle dose, and further de-escalation will be studied if needed to determine a safe and tolerable dose in this population of colorectal cancer patients.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
52 years
n=7 Participants
|
51.5 years
n=5 Participants
|
52 years
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
41 participants
n=7 Participants
|
8 participants
n=5 Participants
|
91 participants
n=4 Participants
|
|
ECOG Performance Status
0
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
ECOG Performance Status
1
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Time from randomization date to either disease progression or death from any cause, whichever occurs first, assessed for up to 16 monthsDisease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and will be documented at each enrolling site with no central review planned. PFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.05. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced.
Outcome measures
| Measure |
Arm A (Binimetinib, Palbociclib)
n=42 Participants
Patients receive binimetinib PO BID on days 1-28 and palbociclib PO QD on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Binimetinib: Given PO\>
\>\>
\>
\>\> Palbociclib: Given PO
|
Arm B (Trifluridine and Tipiracil Hydrochloride)
n=41 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\>
\>\>
\>
\>\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
Safety Run-In Cohort
In the safety run-in, an initial cohort will receive palbociclib orally once daily on days 1-21 out of a 28 day cycle and binimetinib orally twice per day continuously at 30 mg BID daily. The starting dose of palbociclib will be 100 mg orally once daily on days 1-21 out of a 28 day cycle. If the starting dose is not well tolerated, with 2 or more subjects experiencing excessive toxicity as defined in Section 7.15, then the dose will be reduced to 75 mg orally once daily on days 1-21 out of a 28 day cycle dose, and further de-escalation will be studied if needed to determine a safe and tolerable dose in this population of colorectal cancer patients.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
2.3 months
Interval 2.0 to 3.0
|
2.2 months
Interval 2.1 to 2.3
|
—
|
SECONDARY outcome
Timeframe: Up to 16 monthsAssessment of response data will be performed on the basis of definitions of responses according to RECIST version (v)1.1. Objective response is defined as a complete or partial response by RECIST v1.1. This will be reported as the number of patients experiencing an objective response.
Outcome measures
| Measure |
Arm A (Binimetinib, Palbociclib)
n=42 Participants
Patients receive binimetinib PO BID on days 1-28 and palbociclib PO QD on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Binimetinib: Given PO\>
\>\>
\>
\>\> Palbociclib: Given PO
|
Arm B (Trifluridine and Tipiracil Hydrochloride)
n=41 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\>
\>\>
\>
\>\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
Safety Run-In Cohort
In the safety run-in, an initial cohort will receive palbociclib orally once daily on days 1-21 out of a 28 day cycle and binimetinib orally twice per day continuously at 30 mg BID daily. The starting dose of palbociclib will be 100 mg orally once daily on days 1-21 out of a 28 day cycle. If the starting dose is not well tolerated, with 2 or more subjects experiencing excessive toxicity as defined in Section 7.15, then the dose will be reduced to 75 mg orally once daily on days 1-21 out of a 28 day cycle dose, and further de-escalation will be studied if needed to determine a safe and tolerable dose in this population of colorectal cancer patients.
|
|---|---|---|---|
|
Overall Response Rate
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Time from first dose of study treatment to death from any cause, assessed for up to 24 monthsWill use Kaplan-Meier methods to evaluate time to event endpoints, and will report median OS and its 95% confidence interval.
Outcome measures
| Measure |
Arm A (Binimetinib, Palbociclib)
n=42 Participants
Patients receive binimetinib PO BID on days 1-28 and palbociclib PO QD on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Binimetinib: Given PO\>
\>\>
\>
\>\> Palbociclib: Given PO
|
Arm B (Trifluridine and Tipiracil Hydrochloride)
n=41 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\>
\>\>
\>
\>\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
Safety Run-In Cohort
In the safety run-in, an initial cohort will receive palbociclib orally once daily on days 1-21 out of a 28 day cycle and binimetinib orally twice per day continuously at 30 mg BID daily. The starting dose of palbociclib will be 100 mg orally once daily on days 1-21 out of a 28 day cycle. If the starting dose is not well tolerated, with 2 or more subjects experiencing excessive toxicity as defined in Section 7.15, then the dose will be reduced to 75 mg orally once daily on days 1-21 out of a 28 day cycle dose, and further de-escalation will be studied if needed to determine a safe and tolerable dose in this population of colorectal cancer patients.
|
|---|---|---|---|
|
Overall Survival (OS)
|
7.7 months
Interval 5.1 to 13.1
|
6.8 months
Interval 5.5 to 8.4
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsThe number of patients experiencing a grade 3+ adverse event, regardless of attribution, will be reported.
Outcome measures
| Measure |
Arm A (Binimetinib, Palbociclib)
n=42 Participants
Patients receive binimetinib PO BID on days 1-28 and palbociclib PO QD on days 1-21. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\> \>\>
\>
\>\> Binimetinib: Given PO\>
\>\>
\>
\>\> Palbociclib: Given PO
|
Arm B (Trifluridine and Tipiracil Hydrochloride)
n=41 Participants
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may optionally crossover to Arm A.\>
\>\>
\>
\>\> Trifluridine and Tipiracil Hydrochloride: Given PO
|
Safety Run-In Cohort
n=8 Participants
In the safety run-in, an initial cohort will receive palbociclib orally once daily on days 1-21 out of a 28 day cycle and binimetinib orally twice per day continuously at 30 mg BID daily. The starting dose of palbociclib will be 100 mg orally once daily on days 1-21 out of a 28 day cycle. If the starting dose is not well tolerated, with 2 or more subjects experiencing excessive toxicity as defined in Section 7.15, then the dose will be reduced to 75 mg orally once daily on days 1-21 out of a 28 day cycle dose, and further de-escalation will be studied if needed to determine a safe and tolerable dose in this population of colorectal cancer patients.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
25 Participants
|
28 Participants
|
6 Participants
|
Adverse Events
Arm A (Binimetinib, Palbociclib)
Serious events: 9 serious events
Other events: 38 other events
Deaths: 29 deaths
Arm B (Trifluridine and Tipiracil Hydrochloride)
Serious events: 12 serious events
Other events: 39 other events
Deaths: 18 deaths
Crossover
Serious events: 5 serious events
Other events: 21 other events
Deaths: 15 deaths
Safety Run-In Cohort
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A (Binimetinib, Palbociclib)
n=42 participants at risk
Palbociclib: Given PO
|
Arm B (Trifluridine and Tipiracil Hydrochloride)
n=41 participants at risk
Trifluridine and Tipiracil Hydrochloride: Given PO
|
Crossover
n=21 participants at risk
After completion of treatment with Trifluridine and Tipiracil Hydrochloride: Given PO, patients were given the option of being treated with Palbociclib: Given PO, crossing over from arm B to arm A.
|
Safety Run-In Cohort
n=8 participants at risk
In the safety run-in, an initial cohort will receive palbociclib orally once daily on days 1-21 out of a 28 day cycle and binimetinib orally twice per day continuously at 30 mg BID daily. The starting dose of palbociclib will be 100 mg orally once daily on days 1-21 out of a 28 day cycle. If the starting dose is not well tolerated, with 2 or more subjects experiencing excessive toxicity as defined in Section 7.15, then the dose will be reduced to 75 mg orally once daily on days 1-21 out of a 28 day cycle dose, and further de-escalation will be studied if needed to determine a safe and tolerable dose in this population of colorectal cancer patients.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/42 • Number of events 1 • 24 months
|
4.9%
2/41 • Number of events 2 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
2/42 • Number of events 2 • 24 months
|
7.3%
3/41 • Number of events 3 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
4.8%
2/42 • Number of events 2 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/42 • 24 months
|
4.9%
2/41 • Number of events 2 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
General disorders
Chills
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
General disorders
Fatigue
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
General disorders
Fever
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Hepatobiliary disorders
Hepatic failure
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Investigations
CPK increased
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Cardiac troponin T increased
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Ejection fraction decreased
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Investigations
Neutrophil count decreased
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Platelet count decreased
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
Other adverse events
| Measure |
Arm A (Binimetinib, Palbociclib)
n=42 participants at risk
Palbociclib: Given PO
|
Arm B (Trifluridine and Tipiracil Hydrochloride)
n=41 participants at risk
Trifluridine and Tipiracil Hydrochloride: Given PO
|
Crossover
n=21 participants at risk
After completion of treatment with Trifluridine and Tipiracil Hydrochloride: Given PO, patients were given the option of being treated with Palbociclib: Given PO, crossing over from arm B to arm A.
|
Safety Run-In Cohort
n=8 participants at risk
In the safety run-in, an initial cohort will receive palbociclib orally once daily on days 1-21 out of a 28 day cycle and binimetinib orally twice per day continuously at 30 mg BID daily. The starting dose of palbociclib will be 100 mg orally once daily on days 1-21 out of a 28 day cycle. If the starting dose is not well tolerated, with 2 or more subjects experiencing excessive toxicity as defined in Section 7.15, then the dose will be reduced to 75 mg orally once daily on days 1-21 out of a 28 day cycle dose, and further de-escalation will be studied if needed to determine a safe and tolerable dose in this population of colorectal cancer patients.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Renal and urinary disorders
Urinary retention
|
7.1%
3/42 • Number of events 3 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
4.8%
2/42 • Number of events 3 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/42 • Number of events 2 • 24 months
|
9.8%
4/41 • Number of events 13 • 24 months
|
9.5%
2/21 • Number of events 4 • 24 months
|
37.5%
3/8 • Number of events 6 • 24 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.4%
1/42 • Number of events 3 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Renal and urinary disorders
Hematuria
|
2.4%
1/42 • Number of events 2 • 24 months
|
2.4%
1/41 • Number of events 4 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
7/42 • Number of events 10 • 24 months
|
7.3%
3/41 • Number of events 4 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
40.5%
17/42 • Number of events 28 • 24 months
|
63.4%
26/41 • Number of events 46 • 24 months
|
81.0%
17/21 • Number of events 30 • 24 months
|
75.0%
6/8 • Number of events 11 • 24 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 3 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Eye disorders
Blurred vision
|
7.1%
3/42 • Number of events 3 • 24 months
|
0.00%
0/41 • 24 months
|
14.3%
3/21 • Number of events 4 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Eye disorders
Dry eye
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Eye disorders
Eye disorders - Other, specify
|
4.8%
2/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 4 • 24 months
|
|
Eye disorders
Eye pain
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Eye disorders
Floaters
|
2.4%
1/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
9.5%
2/21 • Number of events 3 • 24 months
|
0.00%
0/8 • 24 months
|
|
Eye disorders
Retinopathy
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/42 • 24 months
|
7.3%
3/41 • Number of events 5 • 24 months
|
9.5%
2/21 • Number of events 5 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
6/42 • Number of events 8 • 24 months
|
24.4%
10/41 • Number of events 16 • 24 months
|
33.3%
7/21 • Number of events 10 • 24 months
|
25.0%
2/8 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.4%
1/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Ascites
|
4.8%
2/42 • Number of events 2 • 24 months
|
9.8%
4/41 • Number of events 4 • 24 months
|
9.5%
2/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Bloating
|
4.8%
2/42 • Number of events 3 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
6/42 • Number of events 7 • 24 months
|
14.6%
6/41 • Number of events 7 • 24 months
|
19.0%
4/21 • Number of events 6 • 24 months
|
25.0%
2/8 • Number of events 3 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
31.0%
13/42 • Number of events 33 • 24 months
|
24.4%
10/41 • Number of events 14 • 24 months
|
38.1%
8/21 • Number of events 11 • 24 months
|
62.5%
5/8 • Number of events 10 • 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/42 • Number of events 3 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
2/42 • Number of events 3 • 24 months
|
4.9%
2/41 • Number of events 7 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.5%
4/42 • Number of events 6 • 24 months
|
12.2%
5/41 • Number of events 8 • 24 months
|
14.3%
3/21 • Number of events 5 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
4.8%
2/42 • Number of events 7 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.8%
2/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
7/42 • Number of events 14 • 24 months
|
0.00%
0/41 • 24 months
|
19.0%
4/21 • Number of events 6 • 24 months
|
25.0%
2/8 • Number of events 7 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
31.0%
13/42 • Number of events 22 • 24 months
|
36.6%
15/41 • Number of events 29 • 24 months
|
42.9%
9/21 • Number of events 10 • 24 months
|
50.0%
4/8 • Number of events 10 • 24 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 3 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Rectal pain
|
2.4%
1/42 • Number of events 2 • 24 months
|
4.9%
2/41 • Number of events 3 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 6 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
26.2%
11/42 • Number of events 15 • 24 months
|
29.3%
12/41 • Number of events 24 • 24 months
|
28.6%
6/21 • Number of events 8 • 24 months
|
37.5%
3/8 • Number of events 6 • 24 months
|
|
General disorders
Chills
|
4.8%
2/42 • Number of events 3 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
25.0%
2/8 • Number of events 2 • 24 months
|
|
General disorders
Edema face
|
2.4%
1/42 • Number of events 3 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
12.5%
1/8 • Number of events 3 • 24 months
|
|
General disorders
Edema limbs
|
14.3%
6/42 • Number of events 15 • 24 months
|
12.2%
5/41 • Number of events 12 • 24 months
|
19.0%
4/21 • Number of events 9 • 24 months
|
37.5%
3/8 • Number of events 7 • 24 months
|
|
General disorders
Fatigue
|
42.9%
18/42 • Number of events 45 • 24 months
|
31.7%
13/41 • Number of events 32 • 24 months
|
61.9%
13/21 • Number of events 17 • 24 months
|
62.5%
5/8 • Number of events 10 • 24 months
|
|
General disorders
Fever
|
9.5%
4/42 • Number of events 5 • 24 months
|
0.00%
0/41 • 24 months
|
9.5%
2/21 • Number of events 2 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
General disorders
Flu like symptoms
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
General disorders
Gait disturbance
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
2.4%
1/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
General disorders
Neck edema
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/42 • Number of events 3 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
General disorders
Pain
|
0.00%
0/42 • 24 months
|
7.3%
3/41 • Number of events 4 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.4%
1/42 • Number of events 1 • 24 months
|
7.3%
3/41 • Number of events 3 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Infections and infestations
Papulopustular rash
|
7.1%
3/42 • Number of events 4 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • Number of events 2 • 24 months
|
2.4%
1/41 • Number of events 2 • 24 months
|
9.5%
2/21 • Number of events 3 • 24 months
|
0.00%
0/8 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
7/42 • Number of events 9 • 24 months
|
14.6%
6/41 • Number of events 6 • 24 months
|
19.0%
4/21 • Number of events 7 • 24 months
|
37.5%
3/8 • Number of events 6 • 24 months
|
|
Investigations
Alkaline phosphatase increased
|
26.2%
11/42 • Number of events 14 • 24 months
|
31.7%
13/41 • Number of events 26 • 24 months
|
42.9%
9/21 • Number of events 16 • 24 months
|
62.5%
5/8 • Number of events 8 • 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
23.8%
10/42 • Number of events 15 • 24 months
|
22.0%
9/41 • Number of events 13 • 24 months
|
33.3%
7/21 • Number of events 12 • 24 months
|
50.0%
4/8 • Number of events 6 • 24 months
|
|
Investigations
Blood bilirubin increased
|
9.5%
4/42 • Number of events 5 • 24 months
|
22.0%
9/41 • Number of events 13 • 24 months
|
9.5%
2/21 • Number of events 2 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Investigations
CPK increased
|
35.7%
15/42 • Number of events 38 • 24 months
|
0.00%
0/41 • 24 months
|
33.3%
7/21 • Number of events 11 • 24 months
|
75.0%
6/8 • Number of events 12 • 24 months
|
|
Investigations
Cardiac troponin I increased
|
4.8%
2/42 • Number of events 4 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Cardiac troponin T increased
|
4.8%
2/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 4 • 24 months
|
|
Investigations
Cholesterol high
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Creatinine increased
|
7.1%
3/42 • Number of events 3 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
14.3%
3/21 • Number of events 6 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
|
Investigations
Investigations - Other, specify
|
7.1%
3/42 • Number of events 5 • 24 months
|
4.9%
2/41 • Number of events 4 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Lymphocyte count decreased
|
16.7%
7/42 • Number of events 9 • 24 months
|
29.3%
12/41 • Number of events 17 • 24 months
|
23.8%
5/21 • Number of events 8 • 24 months
|
37.5%
3/8 • Number of events 5 • 24 months
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Neutrophil count decreased
|
35.7%
15/42 • Number of events 35 • 24 months
|
53.7%
22/41 • Number of events 37 • 24 months
|
38.1%
8/21 • Number of events 14 • 24 months
|
25.0%
2/8 • Number of events 4 • 24 months
|
|
Investigations
Platelet count decreased
|
42.9%
18/42 • Number of events 37 • 24 months
|
24.4%
10/41 • Number of events 26 • 24 months
|
28.6%
6/21 • Number of events 8 • 24 months
|
75.0%
6/8 • Number of events 12 • 24 months
|
|
Investigations
Weight gain
|
2.4%
1/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
Weight loss
|
2.4%
1/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
14.3%
3/21 • Number of events 3 • 24 months
|
0.00%
0/8 • 24 months
|
|
Investigations
White blood cell decreased
|
38.1%
16/42 • Number of events 29 • 24 months
|
39.0%
16/41 • Number of events 40 • 24 months
|
23.8%
5/21 • Number of events 11 • 24 months
|
25.0%
2/8 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
7/42 • Number of events 9 • 24 months
|
17.1%
7/41 • Number of events 9 • 24 months
|
23.8%
5/21 • Number of events 10 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1 • 24 months
|
4.9%
2/41 • Number of events 2 • 24 months
|
9.5%
2/21 • Number of events 2 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
3/42 • Number of events 6 • 24 months
|
2.4%
1/41 • Number of events 7 • 24 months
|
9.5%
2/21 • Number of events 3 • 24 months
|
12.5%
1/8 • Number of events 5 • 24 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.4%
9/42 • Number of events 12 • 24 months
|
17.1%
7/41 • Number of events 13 • 24 months
|
23.8%
5/21 • Number of events 8 • 24 months
|
37.5%
3/8 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.5%
4/42 • Number of events 6 • 24 months
|
4.9%
2/41 • Number of events 2 • 24 months
|
14.3%
3/21 • Number of events 3 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 2 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
2/42 • Number of events 2 • 24 months
|
7.3%
3/41 • Number of events 6 • 24 months
|
9.5%
2/21 • Number of events 3 • 24 months
|
0.00%
0/8 • 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.1%
3/42 • Number of events 6 • 24 months
|
7.3%
3/41 • Number of events 6 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
2/42 • Number of events 2 • 24 months
|
9.8%
4/41 • Number of events 7 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
25.0%
2/8 • Number of events 4 • 24 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
4/42 • Number of events 6 • 24 months
|
7.3%
3/41 • Number of events 5 • 24 months
|
19.0%
4/21 • Number of events 9 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
6/42 • Number of events 9 • 24 months
|
4.9%
2/41 • Number of events 4 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.4%
1/42 • Number of events 2 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
2/42 • Number of events 3 • 24 months
|
4.9%
2/41 • Number of events 3 • 24 months
|
9.5%
2/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
3/42 • Number of events 5 • 24 months
|
2.4%
1/41 • Number of events 2 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
25.0%
2/8 • Number of events 3 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
19.0%
4/21 • Number of events 6 • 24 months
|
0.00%
0/8 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 2 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 2 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Nervous system disorders
Concentration impairment
|
2.4%
1/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • Number of events 4 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
14.3%
3/21 • Number of events 6 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Nervous system disorders
Dysgeusia
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Nervous system disorders
Headache
|
0.00%
0/42 • 24 months
|
4.9%
2/41 • Number of events 2 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Nervous system disorders
Lethargy
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
4/42 • Number of events 5 • 24 months
|
9.8%
4/41 • Number of events 6 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Nervous system disorders
Seizure
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Nervous system disorders
Tremor
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Psychiatric disorders
Anxiety
|
7.1%
3/42 • Number of events 7 • 24 months
|
7.3%
3/41 • Number of events 7 • 24 months
|
9.5%
2/21 • Number of events 3 • 24 months
|
0.00%
0/8 • 24 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/42 • 24 months
|
4.9%
2/41 • Number of events 2 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
3/42 • Number of events 5 • 24 months
|
12.2%
5/41 • Number of events 5 • 24 months
|
14.3%
3/21 • Number of events 4 • 24 months
|
25.0%
2/8 • Number of events 4 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.9%
5/42 • Number of events 11 • 24 months
|
14.6%
6/41 • Number of events 9 • 24 months
|
14.3%
3/21 • Number of events 4 • 24 months
|
37.5%
3/8 • Number of events 5 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
2/42 • Number of events 4 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 3 • 24 months
|
0.00%
0/8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/42 • 24 months
|
7.3%
3/41 • Number of events 3 • 24 months
|
9.5%
2/21 • Number of events 4 • 24 months
|
0.00%
0/8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/42 • 24 months
|
4.9%
2/41 • Number of events 2 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
2.4%
1/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.4%
1/42 • Number of events 1 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/42 • 24 months
|
4.9%
2/41 • Number of events 4 • 24 months
|
4.8%
1/21 • Number of events 2 • 24 months
|
0.00%
0/8 • 24 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
1/42 • Number of events 2 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
0.00%
0/21 • 24 months
|
25.0%
2/8 • Number of events 3 • 24 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 2 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.4%
1/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
0.00%
0/21 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • Number of events 2 • 24 months
|
4.9%
2/41 • Number of events 5 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
12.5%
1/8 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
54.8%
23/42 • Number of events 48 • 24 months
|
4.9%
2/41 • Number of events 4 • 24 months
|
47.6%
10/21 • Number of events 19 • 24 months
|
87.5%
7/8 • Number of events 15 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.0%
8/42 • Number of events 14 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
9.5%
2/21 • Number of events 2 • 24 months
|
50.0%
4/8 • Number of events 6 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.4%
1/42 • Number of events 1 • 24 months
|
2.4%
1/41 • Number of events 1 • 24 months
|
9.5%
2/21 • Number of events 3 • 24 months
|
0.00%
0/8 • 24 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 2 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Vascular disorders
Hot flashes
|
0.00%
0/42 • 24 months
|
2.4%
1/41 • Number of events 2 • 24 months
|
0.00%
0/21 • 24 months
|
0.00%
0/8 • 24 months
|
|
Vascular disorders
Hypertension
|
14.3%
6/42 • Number of events 10 • 24 months
|
14.6%
6/41 • Number of events 11 • 24 months
|
19.0%
4/21 • Number of events 5 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/42 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
0.00%
0/8 • 24 months
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/42 • Number of events 2 • 24 months
|
0.00%
0/41 • 24 months
|
4.8%
1/21 • Number of events 1 • 24 months
|
12.5%
1/8 • Number of events 2 • 24 months
|
Additional Information
Scott Kopetz, M.D.
University of Texas; MD Anderson Cancer Center
Phone: (507) 266-0800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place