Trial Outcomes & Findings for Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients (NCT NCT01738646)
NCT ID: NCT01738646
Last Updated: 2017-03-06
Results Overview
The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. Based on Response Assessment in Neuro-Oncology (RANO) criteria, progression is defined as a ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of non-measurable disease. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
6 months
Results posted on
2017-03-06
Participant Flow
48 participants signed consent. 8 participants are considered screen failures. 40 participants received treatment.
Participant milestones
| Measure |
Vorinostat & Bevacizumab
Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Vorinostat & Bevacizumab
Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
|
|---|---|
|
Overall Study
Still Receiving Treatment
|
2
|
Baseline Characteristics
Ph II SAHA and Bevacizumab for Recurrent Malignant Glioma Patients
Baseline characteristics by cohort
| Measure |
Vorinostat & Bevacizumab
n=40 Participants
Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
|
|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent-to-treat
The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. Based on Response Assessment in Neuro-Oncology (RANO) criteria, progression is defined as a ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of non-measurable disease. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.
Outcome measures
| Measure |
Vorinostat & Bevacizumab
n=40 Participants
Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
|
|---|---|
|
Six-month Progression-free Survival (PFS6)
|
30 percentage of participants
Interval 16.8 to 44.4
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Intent-to-treat
The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every second cycle (every 8 weeks) thereafter.
Outcome measures
| Measure |
Vorinostat & Bevacizumab
n=40 Participants
Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
|
|---|---|
|
Radiographic Response
|
22.5 percentage of participants
Interval 12.1 to 37.7
|
SECONDARY outcome
Timeframe: 2.7 YearsPopulation: Intent-to-treat
The percentage of participants who experience grade 3 or greater, treatment-related, non-hematologic toxicities will be calculated.
Outcome measures
| Measure |
Vorinostat & Bevacizumab
n=40 Participants
Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
|
|---|---|
|
Percentage of Participants Who Experience Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.
|
40 percentage of participants
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Intent-to-treat
Progression-free survival is defined as the time in months from the start of protocol treatment until the date of progression or death if death occurred before progression. If the participant is alive and progression-free, PFS will be censored at the date of last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.
Outcome measures
| Measure |
Vorinostat & Bevacizumab
n=40 Participants
Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
|
|---|---|
|
Median Progression-free Survival (PFS)
|
3.7 months
Interval 2.9 to 4.8
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: Intent-to-treat
Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.
Outcome measures
| Measure |
Vorinostat & Bevacizumab
n=40 Participants
Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
|
|---|---|
|
Median Overall Survival (OS)
|
10.4 months
Interval 7.6 to 12.8
|
Adverse Events
Vorinostat & Bevacizumab
Serious events: 12 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vorinostat & Bevacizumab
n=40 participants at risk
Patients will be evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|---|---|
|
Cardiac disorders
Sinus bradycardia
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Enterocolitis
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Death NOS
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Fatigue
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Fever
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Malaise
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Lung infection
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Edema cerebral
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Seizure
|
17.5%
7/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Vascular disorders
Thromboembolic event
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
Other adverse events
| Measure |
Vorinostat & Bevacizumab
n=40 participants at risk
Patients will be evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
15/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Cardiac disorders
Sinus bradycardia
|
12.5%
5/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Ear and labyrinth disorders
Ear pain
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Blurred vision
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Eye disorders
Conjunctivitis
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Bloating
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Constipation
|
27.5%
11/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Dental caries
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
28/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Dysphagia
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Nausea
|
42.5%
17/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
6/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Edema limbs
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Fatigue
|
70.0%
28/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
General disorders
Pain
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Bronchial infection
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Laryngitis
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Paronychia
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Sinusitis
|
10.0%
4/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Skin infection
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Upper respiratory infection
|
15.0%
6/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Urinary tract infection
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Infections and infestations
Wound infection
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Alanine aminotransferase increased
|
22.5%
9/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Alkaline phosphatase increased
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Aspartate aminotransferase increased
|
22.5%
9/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Creatinine increased
|
22.5%
9/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Lymphocyte count decreased
|
80.0%
32/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Neutrophil count decreased
|
55.0%
22/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Platelet count decreased
|
82.5%
33/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
Weight loss
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Investigations
White blood cell decreased
|
67.5%
27/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
5/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
67.5%
27/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
5/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
10/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
4/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
8/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.5%
11/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
10/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
5/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Dysphasia
|
10.0%
4/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Headache
|
42.5%
17/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Memory impairment
|
15.0%
6/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Paresthesia
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Seizure
|
15.0%
6/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Nervous system disorders
Tremor
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Agitation
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Delirium
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Psychiatric disorders
Insomnia
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Renal and urinary disorders
Proteinuria
|
32.5%
13/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Reproductive system and breast disorders
Dyspareunia
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.0%
6/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
22.5%
9/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
30.0%
12/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
2/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.5%
9/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.5%
1/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Vascular disorders
Hypertension
|
35.0%
14/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
|
Vascular disorders
Thromboembolic event
|
7.5%
3/40 • From the start of study treatment for a patient until 30 days after treatment is discontinued.
Patients will be evaluated for adverse events (AEs) (all grades), serious AEs, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place