Trial Outcomes & Findings for Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study (NCT NCT03872427)

NCT ID: NCT03872427

Last Updated: 2025-11-14

Results Overview

Best overall response rate (BORR) based on RECIST V1.1 achieved by 6 months of CB-839 HCl treatment

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

Up to 6 months from treatment start date

Results posted on

2025-11-14

Participant Flow

Out of the 55 patients enrolled, one patient did not receive treatment due to a death before starting the trial.

Participant milestones

Participant milestones
Measure
Cohort 1
NF1 mutant malignant peripheral nerve sheath tumors (MPNST)
Cohort 2
NF1 mutant other cancers
Cohort 3
KEAP1/NRF2 mutant cancers
Cohort 4
STK11/LKB1 mutant cancers
Overall Study
STARTED
9
26
9
10
Overall Study
COMPLETED
9
26
9
10
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1
n=9 Participants
NF1 mutant malignant peripheral nerve sheath tumors (MPNST)
Cohort 2
n=26 Participants
NF1 mutant other cancers
Cohort 3
n=9 Participants
KEAP1/NRF2 mutant cancers
Cohort 4
n=10 Participants
STK11/LKB1 mutant cancers
Total
n=54 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
0 Participants
n=45 Participants
0 Participants
n=44 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=10 Participants
12 Participants
n=10 Participants
7 Participants
n=20 Participants
8 Participants
n=45 Participants
34 Participants
n=44 Participants
Age, Categorical
>=65 years
2 Participants
n=10 Participants
14 Participants
n=10 Participants
2 Participants
n=20 Participants
2 Participants
n=45 Participants
20 Participants
n=44 Participants
Sex: Female, Male
Female
4 Participants
n=10 Participants
17 Participants
n=10 Participants
4 Participants
n=20 Participants
5 Participants
n=45 Participants
30 Participants
n=44 Participants
Sex: Female, Male
Male
5 Participants
n=10 Participants
9 Participants
n=10 Participants
5 Participants
n=20 Participants
5 Participants
n=45 Participants
24 Participants
n=44 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
1 Participants
n=45 Participants
2 Participants
n=44 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=10 Participants
26 Participants
n=10 Participants
9 Participants
n=20 Participants
9 Participants
n=45 Participants
52 Participants
n=44 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
0 Participants
n=45 Participants
0 Participants
n=44 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
0 Participants
n=45 Participants
0 Participants
n=44 Participants
Race (NIH/OMB)
Asian
0 Participants
n=10 Participants
0 Participants
n=10 Participants
1 Participants
n=20 Participants
1 Participants
n=45 Participants
2 Participants
n=44 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
0 Participants
n=45 Participants
0 Participants
n=44 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=10 Participants
2 Participants
n=10 Participants
1 Participants
n=20 Participants
1 Participants
n=45 Participants
9 Participants
n=44 Participants
Race (NIH/OMB)
White
4 Participants
n=10 Participants
24 Participants
n=10 Participants
7 Participants
n=20 Participants
7 Participants
n=45 Participants
42 Participants
n=44 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
0 Participants
n=45 Participants
0 Participants
n=44 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
1 Participants
n=45 Participants
1 Participants
n=44 Participants
Region of Enrollment
United States
9 participants
n=10 Participants
26 participants
n=10 Participants
9 participants
n=20 Participants
10 participants
n=45 Participants
54 participants
n=44 Participants

PRIMARY outcome

Timeframe: Up to 6 months from treatment start date

Best overall response rate (BORR) based on RECIST V1.1 achieved by 6 months of CB-839 HCl treatment

Outcome measures

Outcome measures
Measure
Cohort 4
n=10 Participants
STK11/LKB1 mutant cancers
Cohort 1
n=9 Participants
NF1 mutant malignant peripheral nerve sheath tumors (MPNST)
Cohort 2
n=26 Participants
NF1 mutant other cancers
Cohort 3
n=9 Participants
KEAP1/NRF2 mutant cancers
Best Overall Response Rate by 6 Months
Progressive disease (PD)
5 Participants
4 Participants
14 Participants
6 Participants
Best Overall Response Rate by 6 Months
Treatment Failure
1 Participants
1 Participants
1 Participants
1 Participants
Best Overall Response Rate by 6 Months
Stable Disease (SD)
4 Participants
4 Participants
10 Participants
2 Participants
Best Overall Response Rate by 6 Months
Complete Response (CR)/Partial response (PR)
0 Participants
0 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 2 years from treatment start date

Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Will tabulate toxicity by cohort, type, severity and attribution.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time to progression or death whichever comes first, assessed up to 2 years from treatment start date

Will estimate using the Kaplan-Meier method with time zero set to cycle 1, day 1 (C1D1). Will estimate the medians and select probabilities along with 95% confidence intervals. If more than a handful of patients die without progression, will use Aalen-Johansen estimates to adjust for the competing risk of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time to progression starting at C1D1, assessed up to 2 years from treatment start date

Will estimate the medians and select probabilities along with 95% confidence intervals. If more than a handful of patients die without progression, will use Aalen-Johansen estimates to adjust for the competing risk of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time to death from any cause, assessed up to 2 years from treatment start date

Will estimate using the Kaplan-Meier method with time zero set to C1D1. Will estimate the medians and select probabilities along with 95% confidence intervals. If more than a handful of patients die without progression, will use Aalen-Johansen estimates to adjust for the competing risk of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment until disease progression/recurrence, assessed up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years from treatment start date

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to between 0-8 hours post-glutaminase inhibitor CB-839 hydrochloride dose

Will assess PD changes before and after treatment using the Wilcoxon signed rank test. Will correlate these changes with response to treatment using Wilcoxon rank sum test. Will also perform a receiver operating characteristic curve analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to between 0-8 hours post-glutaminase inhibitor CB-839 hydrochloride dose

Will assess PD changes before and after treatment using the Wilcoxon signed rank test. Will correlate these changes with response to treatment using Wilcoxon rank sum test. Will also perform a receiver operating characteristic curve analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to between 0-8 hours post-glutaminase inhibitor CB-839 hydrochloride dose

Will assess PD changes before and after treatment using the Wilcoxon signed rank test. Will correlate these changes with response to treatment using Wilcoxon rank sum test. Will also perform a receiver operating characteristic curve analysis.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1

Serious events: 5 serious events
Other events: 9 other events
Deaths: 7 deaths

Cohort 2

Serious events: 7 serious events
Other events: 24 other events
Deaths: 20 deaths

Cohort 3

Serious events: 4 serious events
Other events: 8 other events
Deaths: 6 deaths

Cohort 4

Serious events: 6 serious events
Other events: 10 other events
Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure
Cohort 1
n=9 participants at risk
NF1 mutant malignant peripheral nerve sheath tumors (MPNST)
Cohort 2
n=26 participants at risk
NF1 mutant other cancers
Cohort 3
n=9 participants at risk
KEAP1/NRF2 mutant cancers
Cohort 4
n=10 participants at risk
STK11/LKB1 mutant cancers
Gastrointestinal disorders
Abdominal pain
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Injury, poisoning and procedural complications
Acute kidney injury
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Appendicitis
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Ascites
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Back pain
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Blood and lymphatic system disorders
Bacteremia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Blood and lymphatic system disorders
Blood bilirubin increased
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Cardiac disorders
Chest wall pain
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Colonic obstruction
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Constipation
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
22.2%
2/9 • 4 years
20.0%
2/10 • 4 years
General disorders
Death NOS
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
20.0%
2/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
20.0%
2/10 • 4 years
Nervous system disorders
Encephalopathy
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Esophageal obstruction
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Fever
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Gait disturbance
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
General and admin site - Other - Failure To Thrive
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Generalized edema
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Generalized muscle weakness
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Blood and lymphatic system disorders
Hypercalcemia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Metabolism and nutrition disorders
Hypoglycemia
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Blood and lymphatic system disorders
Hyponatremia
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Hypoxia
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Infections and infestations
Lung infection
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Nausea
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Nervous system disorders
Nervous system - Other - L5 Lumbar Lesion Compress Nerve Route
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Non-cardiac chest pain
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Pain
0.00%
0/9 • 4 years
7.7%
2/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Pleural effusion
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - Hemoptysis
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Tracheal obstruction
22.2%
2/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Tumor pain
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Vomiting
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years

Other adverse events

Other adverse events
Measure
Cohort 1
n=9 participants at risk
NF1 mutant malignant peripheral nerve sheath tumors (MPNST)
Cohort 2
n=26 participants at risk
NF1 mutant other cancers
Cohort 3
n=9 participants at risk
KEAP1/NRF2 mutant cancers
Cohort 4
n=10 participants at risk
STK11/LKB1 mutant cancers
Infections and infestations
Infections & infestations - Other - Covid
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Infections and infestations
Infections & infestations - Other - Covid-19
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Injury, poisoning and procedural complications
Injury/poison/procedure - Other - Dislocation Of Rib (Left)
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Psychiatric disorders
Insomnia
22.2%
2/9 • 4 years
7.7%
2/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Reproductive system and breast disorders
Irregular menstruation
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Investigations
Lymphocyte count decreased
44.4%
4/9 • 4 years
38.5%
10/26 • 4 years
22.2%
2/9 • 4 years
30.0%
3/10 • 4 years
Nervous system disorders
Memory impairment
11.1%
1/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Metabolism and nutrition disorders
Metabolism and nutrition - Other - Positive For Appetite Change
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Muscle cramp
11.1%
1/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Right Hip Pain
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Shaking At Night
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Musculoskel/connect tissue -Other - Tumor Pain (Back)
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Myalgia
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Nausea
33.3%
3/9 • 4 years
34.6%
9/26 • 4 years
11.1%
1/9 • 4 years
30.0%
3/10 • 4 years
Musculoskeletal and connective tissue disorders
Neck pain
11.1%
1/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Investigations
Neutrophil count decreased
22.2%
2/9 • 4 years
19.2%
5/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Non-cardiac chest pain
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Pain
22.2%
2/9 • 4 years
7.7%
2/26 • 4 years
11.1%
1/9 • 4 years
10.0%
1/10 • 4 years
Nervous system disorders
Peripheral motor neuropathy
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Pleural effusion
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Reproductive system and breast disorders
Reproductive and breast - Other - Abnormal Image Finding
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Reproductive system and breast disorders
Reproductive and breast - Other - Sclerosing Intraductal Papilloma Without Atypia
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Cellulitis
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Joint Swelling
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Skin Infection (Cut/Right Foot Wound)
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Skin and subcutaneous tissue disorders
Skin papilloma
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Trismus
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Tumor pain
11.1%
1/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Voice alteration
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Vomiting
22.2%
2/9 • 4 years
23.1%
6/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Metabolism and nutrition disorders
Weight gain
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Metabolism and nutrition disorders
Weight loss
22.2%
2/9 • 4 years
15.4%
4/26 • 4 years
33.3%
3/9 • 4 years
10.0%
1/10 • 4 years
Investigations
White blood cell decreased
22.2%
2/9 • 4 years
19.2%
5/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Investigations
AST increased
0.00%
0/9 • 4 years
30.8%
8/26 • 4 years
11.1%
1/9 • 4 years
10.0%
1/10 • 4 years
Gastrointestinal disorders
Abdominal distension
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Investigations
Activated PTT prolonged
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Allergic reaction
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Blood and lymphatic system disorders
Bacteremia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Blood and lymphatic system disorders
Blood bilirubin increased
0.00%
0/9 • 4 years
11.5%
3/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Blood and lymphatic system disorders
Blood/Lymph - Other - Neutropenia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Infections and infestations
Bronchial infection
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Cholecystitis
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Psychiatric disorders
Depression
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Eye disorders
Dry eye
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Dry mouth
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
11.1%
1/9 • 4 years
10.0%
1/10 • 4 years
Ear and labyrinth disorders
Ear and Labyrinth - Other - Hyperacusis
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Edema limbs
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Investigations
Elevated LDH
0.00%
0/9 • 4 years
15.4%
4/26 • 4 years
22.2%
2/9 • 4 years
0.00%
0/10 • 4 years
Eye disorders
Eye disorders - Other, specify - Visual Disturbance
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Eye disorders
Floaters
0.00%
0/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
GI disorders - Other, specify - Heartburn
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Gastroesophageal reflux disease
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Hiccups
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Metabolism and nutrition disorders
Hypocalcemia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Metabolism and nutrition disorders
Hypokalemia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Metabolism and nutrition disorders
Hypomagnesemia
0.00%
0/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Vascular disorders
Hypotension
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Infections and infestations
Infections & infestations - Other - Covid19 Positive
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Investigations
Lipase increased
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Malaise
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Metabolism and nutrition disorders
Metabolism and nutrition - Other - Lactic Acidosis
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Metabolism and nutrition disorders
Metabolism and nutrition - Other - Metabolic Acidosis
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Mucositis oral
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Nervous system disorders
Nervous system - Other - Numbness To Bilateral Foot R>L
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Nervous system disorders
Neuralgia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Oral dysesthesia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Pain in extremity
0.00%
0/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Nervous system disorders
Paresthesia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Periorbital edema
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Nervous system disorders
Photophobia
0.00%
0/9 • 4 years
23.1%
6/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Investigations
Platelet count decreased
0.00%
0/9 • 4 years
19.2%
5/26 • 4 years
22.2%
2/9 • 4 years
20.0%
2/10 • 4 years
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Investigations
Serum amylase increased
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Infections and infestations
Shingles
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Cardiac disorders
Sinus tachycardia
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue -Other - Itching
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Stomach pain
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Toothache
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Tremor
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Renal and urinary disorders
Urinary frequency
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Infections and infestations
Urinary tract infection
0.00%
0/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Nervous system disorders
Confusion
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Investigations
INR increased
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Rectal pain
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Renal and urinary disorders
Renal & urinary disorders - Other - Difficulty Urination
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Adrenal insufficiency
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Psychiatric disorders
Anxiety
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Nervous system disorders
Delirium
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Hoarseness
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Hypoxia
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Investigations
Investigations - Other, specify - Ldh Increase
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Localized edema
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Skin and subcutaneous tissue disorders
Rash acneiform
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - Hypoxemia
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediast - Other - Pulmonary Opacities
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Seroma
0.00%
0/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Infections and infestations
Bladder infection
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Bruising
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Cardiac disorders
Chest wall pain
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Chills
11.1%
1/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Investigations
Cholesterol high
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Nervous system disorders
Concentration impairment
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Constipation
22.2%
2/9 • 4 years
23.1%
6/26 • 4 years
22.2%
2/9 • 4 years
20.0%
2/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Cough
33.3%
3/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Investigations
Creatinine increased
11.1%
1/9 • 4 years
15.4%
4/26 • 4 years
11.1%
1/9 • 4 years
10.0%
1/10 • 4 years
Metabolism and nutrition disorders
Dehydration
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
20.0%
2/10 • 4 years
Gastrointestinal disorders
Diarrhea
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Nervous system disorders
Dizziness
11.1%
1/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Dysgeusia
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Dysphagia
11.1%
1/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Respiratory, thoracic and mediastinal disorders
Dyspnea
33.3%
3/9 • 4 years
7.7%
2/26 • 4 years
11.1%
1/9 • 4 years
30.0%
3/10 • 4 years
Ear and labyrinth disorders
Ear and Labyrinth - Other - Decreased Hearing
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Edema face
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Eye disorders
Eye disorders - Other, specify - Sty
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
Fall
22.2%
2/9 • 4 years
3.8%
1/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
General disorders
Fatigue
55.6%
5/9 • 4 years
34.6%
9/26 • 4 years
11.1%
1/9 • 4 years
30.0%
3/10 • 4 years
General disorders
Fever
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
General and admin site - Other - Migraine
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
General disorders
General and admin site - Other - Sleep Disorder
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Nervous system disorders
Headache
22.2%
2/9 • 4 years
11.5%
3/26 • 4 years
11.1%
1/9 • 4 years
10.0%
1/10 • 4 years
Metabolism and nutrition disorders
Hypercalcemia
11.1%
1/9 • 4 years
19.2%
5/26 • 4 years
33.3%
3/9 • 4 years
0.00%
0/10 • 4 years
Metabolism and nutrition disorders
Hyperglycemia
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
11.1%
1/9 • 4 years
20.0%
2/10 • 4 years
Metabolism and nutrition disorders
Hyperkalemia
22.2%
2/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Vascular disorders
Hypertension
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Metabolism and nutrition disorders
Hypoalbuminemia
11.1%
1/9 • 4 years
3.8%
1/26 • 4 years
22.2%
2/9 • 4 years
10.0%
1/10 • 4 years
Metabolism and nutrition disorders
Hypoglycemia
11.1%
1/9 • 4 years
0.00%
0/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Metabolism and nutrition disorders
Hyponatremia
55.6%
5/9 • 4 years
26.9%
7/26 • 4 years
44.4%
4/9 • 4 years
40.0%
4/10 • 4 years
Metabolism and nutrition disorders
Hypophosphatemia
22.2%
2/9 • 4 years
3.8%
1/26 • 4 years
22.2%
2/9 • 4 years
0.00%
0/10 • 4 years
Metabolism and nutrition disorders
Anorexia
22.2%
2/9 • 4 years
19.2%
5/26 • 4 years
33.3%
3/9 • 4 years
30.0%
3/10 • 4 years
Musculoskeletal and connective tissue disorders
Arthralgia
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
0.00%
0/10 • 4 years
Musculoskeletal and connective tissue disorders
Back pain
11.1%
1/9 • 4 years
7.7%
2/26 • 4 years
0.00%
0/9 • 4 years
20.0%
2/10 • 4 years
Investigations
ALT increased
22.2%
2/9 • 4 years
42.3%
11/26 • 4 years
11.1%
1/9 • 4 years
0.00%
0/10 • 4 years
Gastrointestinal disorders
Abdominal pain
11.1%
1/9 • 4 years
23.1%
6/26 • 4 years
11.1%
1/9 • 4 years
20.0%
2/10 • 4 years
Investigations
Alkaline phosphatase increased
11.1%
1/9 • 4 years
30.8%
8/26 • 4 years
0.00%
0/9 • 4 years
10.0%
1/10 • 4 years
Blood and lymphatic system disorders
Anemia
22.2%
2/9 • 4 years
38.5%
10/26 • 4 years
55.6%
5/9 • 4 years
30.0%
3/10 • 4 years

Additional Information

Dr. Funda Meric-Bernstam

The University of Texas MD Anderson Cancer Center

Phone: (713) 794-1226

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60