Trial Outcomes & Findings for Carboplatin and Bevacizumab for Recurrent Ependymoma (NCT NCT01295944)

Last Updated: 2025-08-05

Results Overview

Percentage of participants that have progressive disease after 1 year. Kaplan-Meier method is used for the analyses of PFS. Progression is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline. Clear worsening of any evaluable disease, or appearance of any new lesion/site, clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

1 year

Results posted on

2025-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Overall Study STARTED	35
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Overall Study Switched to alternative treatment	1
Overall Study Ineligible	9
Overall Study Withdrawal by Subject	1
Overall Study Participant chose to be treated in Peru	1
Overall Study Participant wanting a local endoscopy surgery to remove more tumor	1
Overall Study Physician Decision	1
Overall Study Participant decided to pursue other treatment before beginning protocol treatment	1
Overall Study Disease progression	4
Overall Study Transferred care before starting new treatment	1

Baseline Characteristics

Carboplatin and Bevacizumab for Recurrent Ependymoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=35 Participants The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	42.497 years STANDARD_DEVIATION 16.55 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic	5 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing	26 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: A total of 35 participants were registered, of which 22 were evaluable. 9 participants were screen failures.4 participants withdrew consent prior to starting treatment.

Outcome measures

Outcome measures
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=22 Participants The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Percentage of Participants That Have Progressive Free Survival (PFS) After 1 Year	76.4 Percentage of participants Interval 52.2 to 89.4

SECONDARY outcome

Timeframe: Up to 6 months and 1 week

Population: A total of 35 participants were registered, of which 22 were evaluable. 9 participants were screen failures.4 participants withdrew consent prior to starting treatment.

Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR) is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions.

Outcome measures

Outcome measures
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=22 Participants The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Number of Participants With a (Complete Response (CR) + Partial Response (PR)) Complete Response	0 Participants
Number of Participants With a (Complete Response (CR) + Partial Response (PR)) Partial Response	2 Participants

SECONDARY outcome

Timeframe: The time from treatment start date until date of death or date last known alive, up to 68 months

Population: A total of 35 participants were registered, of which 22 were evaluable. 9 participants were screen failures.4 participants withdrew consent prior to starting treatment.

OS was calculated by the Kaplan Meier methodology. OS is defined as the time from treatment start date until date of death or date last known alive.

Outcome measures

Outcome measures
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=22 Participants The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Overall Survival (OS)	18.0 Months Interval 12.2 to Due to the small sample size, the upper confidence interval (CI) for the Kaplan-Meier curve for OS is never lower than 0.5, for which the median OS correspond to, therefore the upper CI for the median OS does not exist.

SECONDARY outcome

Timeframe: Completed at baseline, before a brain or spine magnetic resonance imaging (MRI)/clinical evaluation, and at cycle 2, cycle 4, and cycle 6 (each cycle is 28 days)

Population: 17/22 participants were analyzed because 4 completed the MDASI-SP questionnaires only, and 1 participant completed their baseline assessment 6 days into the first cycle and was not counted.

The MDASI-BT consists of 23 symptoms rated on an 11 point scale (0 - not present, to 10 - as bad as you can imagine) to indicate the presence and severity of the symptom. All participants with at least one valid questionnaire are included in the analyses. We calculated the mean core symptom severity score rated on the scale from 0-not present to 10-as bad as you can imagine at the time of clinical evaluation. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity measures. For example, an increase of 2 points or more would mean a moderate improvement, whereas a decrease of 2 points or more would be interpreted as moderate worsening.

Outcome measures

Outcome measures
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=17 Participants The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Mean Core Symptom Severity With Daily Activities Using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) Baseline	1.5 score on a scale Standard Deviation 1.8
Mean Core Symptom Severity With Daily Activities Using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) Cycle 2	2.1 score on a scale Standard Deviation 2.1
Mean Core Symptom Severity With Daily Activities Using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) Cycle 4	1.3 score on a scale Standard Deviation 1.1
Mean Core Symptom Severity With Daily Activities Using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) Cycle 6	1.9 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Completed at baseline, before a brain or spine magnetic resonance imaging (MRI)/clinical evaluation, and at cycle 2, cycle 4, and cycle 6 (each cycle is 28 days)

Population: 7/22 participants were analyzed because 14 completed the MDASI-BT questionnaires only, and 1 participant completed their baseline assessment 6 days into the first cycle and was not counted.

The MDASI-SP consists of 23 symptoms rated on an 11 point scale (0 - not present, to 10 - as bad as you can imagine) to indicate the presence and severity of the symptom. All participants with at least one valid questionnaire are included in the analyses. We calculated the mean core symptom severity score rated on the scale from 0-not present to 10-as bad as you can imagine at the time of clinical evaluation. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity measures. For example, an increase of 2 points or more would mean a moderate improvement, whereas a decrease of 2 points or more would be interpreted as moderate worsening.

Outcome measures

Outcome measures
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=7 Participants The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Mean Core Symptom Severity With Daily Activities Using the MD Anderson Symptom Inventory for Spine Tumors (MDASI-SP) Instrument Baseline	1.4 score on a scale Standard Deviation 0.9
Mean Core Symptom Severity With Daily Activities Using the MD Anderson Symptom Inventory for Spine Tumors (MDASI-SP) Instrument Cycle 2	2.1 score on a scale Standard Deviation 1.7
Mean Core Symptom Severity With Daily Activities Using the MD Anderson Symptom Inventory for Spine Tumors (MDASI-SP) Instrument Cycle 4	2.1 score on a scale Standard Deviation 1.6
Mean Core Symptom Severity With Daily Activities Using the MD Anderson Symptom Inventory for Spine Tumors (MDASI-SP) Instrument Cycle 6	1.5 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Completed at baseline, before a brain or spine magnetic resonance imaging (MRI)/clinical evaluation, and at cycle 2, cycle 4, and cycle 6 (each cycle is 28 days)

The MDASI-BT consists of 23 symptoms rated on an 11 point scale (0 - did not interfere, to 10 - interfered completely) to indicate the symptoms that interfere with a participants life in the last 24 hours. All participants with at least one valid questionnaire are included in the analyses. We calculated the mean core symptom interference score rated on the scale from 0- did not interfere, to 10- interfered completely at the time of clinical evaluation. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom interference measures. For example, an increase of 2 points or more would mean a moderate improvement, whereas a decrease of 2 points or more would be interpreted as moderate worsening.

Outcome measures

Outcome measures
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=17 Participants The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Mean Symptom Interference With Daily Activities Using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) Baseline	1.6 score on a scale Standard Deviation 2.1
Mean Symptom Interference With Daily Activities Using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) Cycle 2	2.1 score on a scale Standard Deviation 2.3
Mean Symptom Interference With Daily Activities Using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) Cycle 4	1.7 score on a scale Standard Deviation 1.9
Mean Symptom Interference With Daily Activities Using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) Cycle 6	2.5 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Completed at baseline, before a brain or spine magnetic resonance imaging (MRI)/clinical evaluation, and at cycle 2, cycle 4, and cycle 6 (each cycle is 28 days)

The MDASI-SP consists of 23 symptoms rated on an 11 point scale (0 - did not interfere, to 10 - interfered completely) to indicate the symptoms that interfere with a participants life in the last 24 hours. All participants with at least one valid questionnaire are included in the analyses. We calculated the mean core symptom interference score rated on the scale from 0- did not interfere, to 10- interfered completely at the time of clinical evaluation. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom interference measures. For example, an increase of 2 points or more would mean a moderate improvement, whereas a decrease of 2 points or more would be interpreted as moderate worsening.

Outcome measures

Outcome measures
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=7 Participants The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Mean Symptom Interference With Daily Activities Using the MD Anderson Symptom Inventory for Spine Tumors (MDASI-SP) Instrument Baseline	1.7 score on a scale Standard Deviation 1.4
Mean Symptom Interference With Daily Activities Using the MD Anderson Symptom Inventory for Spine Tumors (MDASI-SP) Instrument Cycle 2	3.1 score on a scale Standard Deviation 2.4
Mean Symptom Interference With Daily Activities Using the MD Anderson Symptom Inventory for Spine Tumors (MDASI-SP) Instrument Cycle 4	4.1 score on a scale Standard Deviation 3.2
Mean Symptom Interference With Daily Activities Using the MD Anderson Symptom Inventory for Spine Tumors (MDASI-SP) Instrument Cycle 6	4.2 score on a scale Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately, 112 months and 28 days.

Population: A total of 35 participants were registered, of which 22 were evaluable. 9 participants were screen failures.4 participants withdrew consent prior to starting treatment.

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=22 Participants The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	22 Participants

Adverse Events

1/Carboplatin and Bevacizumab for Recurrent Ependymoma

Serious events: 3 serious events

Other events: 22 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=35 participants at risk The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Seizure	2.9% 1/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.

Other adverse events

Other adverse events
Measure	1/Carboplatin and Bevacizumab for Recurrent Ependymoma n=35 participants at risk The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician. Carboplatin: Carboplatin will be given on day 1 of each cycle; the carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target Area Under the Curve (AUC) x (Creatinine clearance (CrCl) + 25; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician Bevacizumab: Bevacizumab will be administered on days 1 and 15 of each cycle. Bevacizumab will be administered at a dose of 10 mg/kg; The total duration of treatment will be 6 cycles. After cycle 6, carboplatin should be discontinued, but bevacizumab may be continued at the discretion of the treating physician.
Gastrointestinal disorders Abdominal pain	2.9% 1/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Psychiatric disorders Agitation	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Alanine aminotransferase increased	8.6% 3/35 • Number of events 5 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Alkaline phosphatase increased	11.4% 4/35 • Number of events 4 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Skin and subcutaneous tissue disorders Alopecia	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Blood and lymphatic system disorders Anemia	22.9% 8/35 • Number of events 35 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Injury, poisoning and procedural complications Ankle fracture	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Anorexia	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Psychiatric disorders Anxiety	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Aspartate aminotransferase increased	8.6% 3/35 • Number of events 12 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Ataxia	5.7% 2/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Musculoskeletal and connective tissue disorders Back pain	8.6% 3/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Bloating	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Blood bilirubin increased	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Eye disorders Blurred vision	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Injury, poisoning and procedural complications Bruising	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
General disorders Chills	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Cognitive disturbance	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Psychiatric disorders Confusion	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Constipation	20.0% 7/35 • Number of events 7 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Creatinine increased	8.6% 3/35 • Number of events 7 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Endocrine disorders Cushingoid	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Psychiatric disorders Depression	8.6% 3/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Diarrhea	11.4% 4/35 • Number of events 4 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Dizziness	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Dry mouth	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Skin and subcutaneous tissue disorders Dry skin	11.4% 4/35 • Number of events 4 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Dysesthesia	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Dyspepsia	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Dysphagia	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Dysphasia	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 5/35 • Number of events 5 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Eye disorders Eye disorders - Other, Diplopia or double vision	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Eye disorders Eye disorders - Other, Peripheral vision	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Injury, poisoning and procedural complications Fall	8.6% 3/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
General disorders Fatigue	31.4% 11/35 • Number of events 16 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Fecal incontinence	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
General disorders Fever	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
General disorders Flu like symptoms	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
General disorders Gait disturbance	8.6% 3/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Headache	22.9% 8/35 • Number of events 11 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Renal and urinary disorders Hematuria	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Respiratory, thoracic and mediastinal disorders Hoarseness	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Hyperglycemia	14.3% 5/35 • Number of events 13 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Hyperkalemia	8.6% 3/35 • Number of events 16 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Hypernatremia	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Vascular disorders Hypertension	20.0% 7/35 • Number of events 12 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Hypocalcemia	5.7% 2/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Hypoglycemia	8.6% 3/35 • Number of events 8 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Hypokalemia	8.6% 3/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Hypomagnesemia	8.6% 3/35 • Number of events 4 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Hyponatremia	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Psychiatric disorders Insomnia	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Intracranial hemorrhage	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Investigations - Other, Alanine aminotransferase decreased	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Investigations - Other, specify	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Reproductive system and breast disorders Irregular menstruation	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
General disorders Irritability	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Blood and lymphatic system disorders Leukocytosis	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Lymphocyte count decreased	20.0% 7/35 • Number of events 21 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Memory impairment	8.6% 3/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, Phosphorus count increased	2.9% 1/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Mucositis oral	8.6% 3/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	8.6% 3/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	2.9% 1/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Musculoskeletal and connective tissue disorders Myalgia	5.7% 2/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Nausea	25.7% 9/35 • Number of events 18 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Musculoskeletal and connective tissue disorders Neck pain	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.9% 1/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Nervous system disorders - Other, specify	2.9% 1/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Nervous system disorders - Other, insomnia	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Nervous system disorders - Other, left-sided numbness	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Nervous system disorders - Other, right tongue nymbness	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Nervous system disorders - Other, neuropathy	2.9% 1/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Neutrophil count decreased	31.4% 11/35 • Number of events 57 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Oral hemorrhage	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
General disorders Pain	5.7% 2/35 • Number of events 3 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Cardiac disorders Palpitations	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Paresthesia	5.7% 2/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Periodontal disease	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations Platelet count decreased	34.3% 12/35 • Number of events 64 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Respiratory, thoracic and mediastinal disorders Productive cough	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Renal and urinary disorders Proteinuria	8.6% 3/35 • Number of events 8 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Skin and subcutaneous tissue disorders Rash acneiform	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Renal and urinary disorders Renal and urinary disorders - Other, rectal bleeding	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Infections and infestations Rhinitis infective	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Seizure	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Infections and infestations Sinusitis	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Syncope	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Vascular disorders Thromboembolic event	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Toothache	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Nervous system disorders Transient ischemic attacks	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Renal and urinary disorders Urinary incontinence	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Renal and urinary disorders Urinary retention	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Infections and infestations Urinary tract infection	2.9% 1/35 • Number of events 2 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Renal and urinary disorders Urinary tract pain	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Reproductive system and breast disorders Vaginal hemorrhage	2.9% 1/35 • Number of events 1 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Gastrointestinal disorders Vomiting	11.4% 4/35 • Number of events 5 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.
Investigations White blood cell decreased	31.4% 11/35 • Number of events 45 • Date treatment consent signed to date off study, approximately, 112 months and 28 days.

Additional Information

Dr. Kevin Camphausen

National Cancer Institute

Phone: 240-760-6205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place