Trial Outcomes & Findings for Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer (NCT NCT03831932)
NCT ID: NCT03831932
Last Updated: 2025-09-19
Results Overview
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2025-09-19
Participant Flow
One participant enrolled to be a part of the phase 1b dose escalation but withdrew from the study prior to being assigned to a dose level.
Participant milestones
| Measure |
Phase 1b 400mg Telaglenastat HCl Cohort
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 1b 600mg Telaglenastat HCl Cohort
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 1b 800mg Telaglenastat HCl Cohort
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 2 Expansion Cohort
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
10
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase 1b 400mg Telaglenastat HCl Cohort
n=3 Participants
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 1b 600mg Telaglenastat HCl Cohort
n=3 Participants
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 1b 800mg Telaglenastat HCl Cohort
n=6 Participants
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 2 Expansion Cohort
n=10 Participants
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
22 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: The recommended phase II dose was determined during the phase 1b portion of the study, so only participants from the phase 1b cohorts are included for analysis.
Outcome measures
| Measure |
Phase 1b Cohorts
n=12 Participants
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
|---|---|
|
Recommended Phase II Dose (RP2D)
Telaglenastat (CB-839) HCl
|
800 milligrams
|
|
Recommended Phase II Dose (RP2D)
Osimertinib (AZD9291)
|
80 milligrams
|
SECONDARY outcome
Timeframe: Up to 28 daysWill be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initiation of therapy to documented progression or death without progression, assessed up to 30 days after completion of therapySurvival will initially be modeled using Kaplan-Meier methods, resulting in median survival times with 95% CI, assuming sufficient events have occurred.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From initiation of therapy to death from any cause, assessed up to 30 days after completion of therapySurvival will initially be modeled using Kaplan-Meier methods, resulting in median survival times with 95% CI, assuming sufficient events have occurred.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 15 of cycle 1, day 2 of cycle 2 and day 1 of each subsequent cycle (each cycle = 28 days)Will be assessed by CB-839 HCl drug levels following both single agent therapy as well as combination therapy with CB-839 HCl and osimertinib (AZD9291). Will explore PK endpoints such as concentration steady state (Css), area under the curve (AUC), clearance (CL), volume of distribution (Vd), and half-life (t1/2) computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations \[GEE\]) to assess the PK and pharmacodynamics (PD) markers described above in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 2 of cycle 2 and day 1 of each subsequent cycle (each cycle = 28 days)Will be assessed by AZD9291 drug levels following combination therapy with CB-839 HCl and AZD9291. Will be assessed by CB-839 HCl drug levels following both single agent therapy as well as combination therapy with CB-839 HCl and AZD9291. Will explore PK endpoints such as Css, AUC, CL, Vd, and t1/2 computed using non-compartmental and compartmental methods. Will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, GEE) to assess the PK and PD markers described above in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to disease progression, assessed up to 30 days after completion of therapyWill be assessed by cell-free deoxyribonucleic acid (cfDNA). All continuous measurements will be summarized using mean +/- standard error of mean (SEM), range, and median at each time point. Changes in these measurements from baseline to after treatment, or baseline to progression will be assessed using paired Wilcoxon tests. Adjustments for multiple comparisons or multiple outcomes will be performed using Bonferroni correction.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to time of disease progression, assessed up to 30 days after completion of therapyWill be assessed by plasma concentrations of these compounds. All continuous measurements will be summarized using mean +/- SEM, range, and median at each time point. Changes in these measurements from baseline to after treatment, or baseline to progression will be assessed using paired Wilcoxon tests. Adjustments for multiple comparisons or multiple outcomes will be performed using Bonferroni correction.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 2 cycles of treatment (each cycle = 28 days)Will be summarized using mean +/- SEM, range, and median. The changes in the FDG-PET/computed tomography (CT) parameter measurements from baseline to after treatment will be compared between responders and non-responders using two sample t-test or Wilcoxon test, whichever is appropriate.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1b 400mg Telaglenastat HCl Cohort
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1b 600mg Telaglenastat HCl Cohort
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1b 800mg Telaglenastat HCl Cohort
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase 2 Expansion Cohort
Serious events: 1 serious events
Other events: 10 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1b 400mg Telaglenastat HCl Cohort
n=3 participants at risk
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 1b 600mg Telaglenastat HCl Cohort
n=3 participants at risk
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 1b 800mg Telaglenastat HCl Cohort
n=6 participants at risk
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 2 Expansion Cohort
n=10 participants at risk
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Hepatobiliary disorders
Biliary duct dilation
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
General disorders
Disease progression
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Gamma-Glutamyl Transferase (GGT) increased
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
General disorders
Pain
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Nervous system disorders
Stroke
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
Other adverse events
| Measure |
Phase 1b 400mg Telaglenastat HCl Cohort
n=3 participants at risk
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 1b 600mg Telaglenastat HCl Cohort
n=3 participants at risk
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 1b 800mg Telaglenastat HCl Cohort
n=6 participants at risk
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
Phase 2 Expansion Cohort
n=10 participants at risk
Patients receive telaglenastat hydrochloride PO BID and osimertinib PO QD (starting cycle 1 day 16 of phase I). Patients undergo blood sample collection and may undergo x-ray imaging, CT scan, MRI, or PET scan throughout the study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT scan
Magnetic Resonance Elastography: Undergo MRI
Osimertinib: Given PO
Positron Emission Tomography: Undergo PET scan
Telaglenastat Hydrochloride: Given PO
X-Ray Imaging: Undergo x-ray imaging
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Eye disorders
Blurred vision
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Investigations
Cardiac troponin I increased
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Cholesterol high
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Eye disorders
Diplopia
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
40.0%
4/10 • Number of events 4 • Up to 2 years
|
|
Eye disorders
Floaters
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
General disorders
Gait disturbance
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Dry heaves
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Psychiatric disorders
Hallucinations
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
50.0%
3/6 • Number of events 3 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
50.0%
3/6 • Number of events 3 • Up to 2 years
|
30.0%
3/10 • Number of events 3 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
50.0%
3/6 • Number of events 3 • Up to 2 years
|
30.0%
3/10 • Number of events 3 • Up to 2 years
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Eye disorders
Photophobia
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
30.0%
3/10 • Number of events 3 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Investigations
Weight gain
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 2 years
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 2 years
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Eye disorders
Flashing Lights during first dose
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Eye disorders
Flashing lights
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Up to 2 years
|
66.7%
2/3 • Number of events 2 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial infection
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Up to 2 years
|
33.3%
1/3 • Number of events 1 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
50.0%
3/6 • Number of events 3 • Up to 2 years
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
General disorders
Costolchondritis
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Infections and infestations
Gum infection
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Gastrointestinal disorders
Gum sensitivity
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Blood and lymphatic system disorders
Iron deficiency
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
33.3%
2/6 • Number of events 2 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infiltrates
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
|
Eye disorders
Sensitive to light
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Infections and infestations
Sinus Infection
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
16.7%
1/6 • Number of events 1 • Up to 2 years
|
0.00%
0/10 • Up to 2 years
|
|
General disorders
Abdominal flutter
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
altered mental status (intermittent)
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
General disorders
Cjills
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Investigations
creatine phosphokinase (CPK) increased
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry nares
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Fecal incontnence
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
mouth ulcer
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
20.0%
2/10 • Number of events 2 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Thrush
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/3 • Up to 2 years
|
0.00%
0/6 • Up to 2 years
|
10.0%
1/10 • Number of events 1 • Up to 2 years
|
Additional Information
Dr. Dwight Owen
The Ohio State University Comprehensive Cancer Center
Phone: 614-685-2039
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60