Trial Outcomes & Findings for Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors (NCT NCT03878095)
NCT ID: NCT03878095
Last Updated: 2026-04-29
Results Overview
The exact two-sided 95% confidence intervals (CIs) for the ORR will be reported. No responses were recorded to be able to calculate the statistics as outlined at registration.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Up to 30 days post treatment after removal from study
Results posted on
2026-04-29
Participant Flow
Participant milestones
| Measure |
Treatment (Olaparib, Ceralasertib)
Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.
Biopsy Procedure: Undergo tumor biopsies
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy
Ceralasertib: Given PO
Computed Tomography: Undergo CT scans
Magnetic Resonance Imaging: Undergo MRI scans
Olaparib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors
Baseline characteristics by cohort
| Measure |
Treatment (Olaparib, Ceralasertib)
n=24 Participants
Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.
Biopsy Procedure: Undergo tumor biopsies
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy
Ceralasertib: Given PO
Computed Tomography: Undergo CT scans
Magnetic Resonance Imaging: Undergo MRI scans
Olaparib: Given PO
|
|---|---|
|
Age, Continuous
|
59 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=9 Participants
|
|
ECOG Performance Status Scale
0
|
7 Participants
n=9 Participants
|
|
ECOG Performance Status Scale
1
|
17 Participants
n=9 Participants
|
|
Tumor Type
Cholangiocarcinoma
|
14 Participants
n=9 Participants
|
|
Tumor Type
Chondrosarcoma
|
4 Participants
n=9 Participants
|
|
Tumor Type
Other
|
6 Participants
n=9 Participants
|
|
IDH Mutation Status
IDH1
|
17 Participants
n=9 Participants
|
|
IDH Mutation Status
IDH2
|
7 Participants
n=9 Participants
|
|
Lines of Systemic Therapy
|
3 Prior lines of systemic therapy
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days post treatment after removal from studyThe exact two-sided 95% confidence intervals (CIs) for the ORR will be reported. No responses were recorded to be able to calculate the statistics as outlined at registration.
Outcome measures
| Measure |
Treatment (Olaparib, Ceralasertib)
n=24 Participants
Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.
Biopsy Procedure: Undergo tumor biopsies
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy
Ceralasertib: Given PO
Computed Tomography: Undergo CT scans
Magnetic Resonance Imaging: Undergo MRI scans
Olaparib: Given PO
|
|---|---|
|
Objective Response Rate (ORR)
Response
|
0 Participants
|
|
Objective Response Rate (ORR)
No Response
|
24 Participants
|
SECONDARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first, assessed up to 30 days after removal from study - Up to 1 yearPFS will be estimated using the Kaplan-Meier method with the 95% CIs. The CI based on the Greenwoods variance will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age and stage of disease on the survival data. The adjusted p-values of the odds ratios and the adjusted 95% confidence interval will be reported.
Outcome measures
| Measure |
Treatment (Olaparib, Ceralasertib)
n=24 Participants
Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.
Biopsy Procedure: Undergo tumor biopsies
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy
Ceralasertib: Given PO
Computed Tomography: Undergo CT scans
Magnetic Resonance Imaging: Undergo MRI scans
Olaparib: Given PO
|
|---|---|
|
Progression Free Survival (PFS)
|
3 months
Interval 3.0 to
Not enough events to calculate.
|
SECONDARY outcome
Timeframe: From start of treatment to time of death, assessed up to 30 days after removal from studyOS will be estimated using the Kaplan-Meier method with the 95% CIs. The CI based on the Greenwoods variance will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age and stage of disease on the survival data. The adjusted p-values of the odds ratios and the adjusted 95% confidence interval will be reported.
Outcome measures
| Measure |
Treatment (Olaparib, Ceralasertib)
n=24 Participants
Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.
Biopsy Procedure: Undergo tumor biopsies
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy
Ceralasertib: Given PO
Computed Tomography: Undergo CT scans
Magnetic Resonance Imaging: Undergo MRI scans
Olaparib: Given PO
|
|---|---|
|
Overall Survival (OS)
|
7.1 months
Interval 3.3 to
Not enough events to calculate.
|
SECONDARY outcome
Timeframe: From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 30 days after removal from studyPopulation: There were no responses, therefore duration of response is not calculable.
Will be estimated using the Kaplan-Meier method with the 95% CIs. The CI based on the Greenwoods variance will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age and stage of disease on the survival data. The adjusted p-values of the odds ratios and the adjusted 95% confidence interval will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days post treatment - (up to 60.75 months)Toxicities will be evaluated utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Outcome measures
| Measure |
Treatment (Olaparib, Ceralasertib)
n=24 Participants
Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.
Biopsy Procedure: Undergo tumor biopsies
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy
Ceralasertib: Given PO
Computed Tomography: Undergo CT scans
Magnetic Resonance Imaging: Undergo MRI scans
Olaparib: Given PO
|
|---|---|
|
Incidence of Adverse Events
Serious Adverse Event · Had an event
|
13 Participants
|
|
Incidence of Adverse Events
Serious Adverse Event · Did not have an event
|
11 Participants
|
|
Incidence of Adverse Events
Non-Serious Adverse Event · Had an event
|
24 Participants
|
|
Incidence of Adverse Events
Non-Serious Adverse Event · Did not have an event
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days post treatmentAbsolute and fold changes for gamma H2AX foci will be calculated between baseline and subsequent follow-up (pre-treatment and on-treatment biopsies). These will be displayed graphically versus (vs.) time for each cohort. Differences will be plotted vs. response status. Wilcoxon sign-rank test as well as paired t-tests will be used to evaluate if differences between baseline and each subsequent time point are significant. Summary statistics will be reported (with 95% confidence intervals) to demonstrate mean differences in fold-change (or log fold-change) between responders and non-responders.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 30 days post treatment2HG levels in tumor and plasma will be compared to treatment responses. The Mann-Whitney U test will be used to test for differences in post-treatment tissue and plasma 2HG concentrations between patients with a response to treatment and those without. Will also apply analysis of covariance for post-treatment plasma concentration in 2HG adjusted for the pre-treatment plasma concentration between patients with a response to treatment and those without.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Olaparib, Ceralasertib)
Serious events: 13 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Olaparib, Ceralasertib)
n=24 participants at risk
Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.
Biopsy Procedure: Undergo tumor biopsies
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy
Ceralasertib: Given PO
Computed Tomography: Undergo CT scans
Magnetic Resonance Imaging: Undergo MRI scans
Olaparib: Given PO
|
|---|---|
|
Investigations
White blood cell decreased
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Nervous system disorders
Edema cerebral
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Nervous system disorders
Stroke
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Cardiac disorders
Pericardial effusion
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Ascites
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
Disease progression
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
Fatigue
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify - Biliary Drain Obstruction/Infection
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify - Biliary Obstruction
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify - Cholangitis
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Infections and infestations
Abdominal infection
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Infections and infestations
Hepatitis viral
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Infections and infestations
Infections and infestations - Other, specify - Sepsis
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Platelet count decreased
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
Other adverse events
| Measure |
Treatment (Olaparib, Ceralasertib)
n=24 participants at risk
Patients receive olaparib PO BID on days 1-28 of each cycle and ceralasertib PO QD on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression, unacceptable toxicity, withdrawal of consent or death. Patients also undergo tumor biopsies during screening and on study, collection of blood samples throughout the trial, and undergo CT and/or MRI scans throughout the trial. Patients may also undergo bone marrow aspiration and biopsy as clinically indicated on study.
Biopsy Procedure: Undergo tumor biopsies
Biospecimen Collection: Undergo collection of blood
Bone Marrow Aspiration: Undergo bone marrow aspiration and biopsy
Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy
Ceralasertib: Given PO
Computed Tomography: Undergo CT scans
Magnetic Resonance Imaging: Undergo MRI scans
Olaparib: Given PO
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
6/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Ascites
|
12.5%
3/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Blood and lymphatic system disorders
Anemia
|
70.8%
17/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Cardiac disorders
Myocardial infarction
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Cardiac disorders
Sinus tachycardia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
3/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Belching
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
9/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
3/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Flatulence
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Dry Heaves
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Epigastric Pain
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify - Heartburn
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Lip pain
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
12/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
8/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
Chills
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
Edema limbs
|
16.7%
4/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
Fatigue
|
33.3%
8/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
Fever
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
General disorders and administration site conditions - Other, specify - Left Vocal Cord Paralysis
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
General disorders and administration site conditions - Other, specify - Right Sided Rib Pain
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
General disorders and administration site conditions - Other, specify - Tachycardia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
General disorders
Pain
|
12.5%
3/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Hepatobiliary disorders
Portal hypertension
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Immune system disorders
Allergic reaction
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Infections and infestations
Hepatitis viral
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Nervous system disorders
Dizziness
|
25.0%
6/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Nervous system disorders
Dysgeusia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Nervous system disorders
Headache
|
16.7%
4/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Nervous system disorders
Memory impairment
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Nervous system disorders
Nervous system disorders - Other, specify - Rigth Thigh Numbness
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Nervous system disorders
Tremor
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Psychiatric disorders
Confusion
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Psychiatric disorders
Depression
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Psychiatric disorders
Insomnia
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify - Creatinine Clearance Decrease
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify - Renal Insufficiency
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.8%
5/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
9/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Vascular disorders
Thromboembolic event
|
12.5%
3/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Vascular disorders
Vascular disorders - Other, specify - Orthostatic Hypotension Dysautonomic Syndrome
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Infections and infestations
Infections and infestations - Other, specify - Ascitic Fluid Escherichia Coli Infection
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Infections and infestations
Infections and infestations - Other, specify - Stomach Flu
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Infections and infestations
Papulopustular rash
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Alkaline phosphatase increased
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
6/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Blood bilirubin increased
|
12.5%
3/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Creatinine increased
|
16.7%
4/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Investigations - Other, specify - Elevated Bun
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
8/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Neutrophil count decreased
|
16.7%
4/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Platelet count decreased
|
33.3%
8/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
Weight loss
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Investigations
White blood cell decreased
|
29.2%
7/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
8/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.3%
2/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
6/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify - Electrolyte Imbalance
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
4.2%
1/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
3/24 • Up to 60.75 months
Adverse events were monitored in each participant for as long as they remained in follow up.
|
Additional Information
Philippos Costa, MD, Assistant Professor of Medicine (Medical Oncology and Hematology)
Yale School of Medicine
Phone: (203) 785-2579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60