Trial Outcomes & Findings for Palbociclib + Ganitumab In Ewing Sarcoma (NCT NCT04129151)
NCT ID: NCT04129151
Last Updated: 2024-08-01
Results Overview
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Participants were followed up to 10.8 months
Results posted on
2024-08-01
Participant Flow
Patients were enrolled between December 2019 and August 2021.
Participant milestones
| Measure |
PALBOCICLIB and GANITUMAB
This is a single arm, open-label, phase 2 study of ganitumab and palbociclib. Patients started treatment with standard dosing (Palbociclib 125 mg on days 1-21 and ganitumab 18 mg/kg on days 1 and 15 of a 28-day cycle). Safety stopping rules were used to monitor for toxicity of this novel combination therapy. Participants received up to 12 cycles of therapy in a single cohort.
The first 3 participants started treatment at standard dosing (Palbociclib 125 mg on days 1-21 and ganitumab 18 mg/kg on days 1 and 15 of a 28-day cycle). After 2 initial patients experienced dose limiting toxicity, safety stopping rules were triggered and the starting palbociclib dose was reduced to 100 mg on days 1-21 (ganitumab dose was not changed). The subsequent 7 participants were treated at the reduced starting dose (Palbociclib 100 mg on days 1-21 and ganitumab 18 mg/kg on days 1 and 15 of a 28-day cycle). This study did not include formal dose escalation given both agents had previously established recommended phase 2 dosing.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
PALBOCICLIB and GANITUMAB
This is a single arm, open-label, phase 2 study of ganitumab and palbociclib. Patients started treatment with standard dosing (Palbociclib 125 mg on days 1-21 and ganitumab 18 mg/kg on days 1 and 15 of a 28-day cycle). Safety stopping rules were used to monitor for toxicity of this novel combination therapy. Participants received up to 12 cycles of therapy in a single cohort.
The first 3 participants started treatment at standard dosing (Palbociclib 125 mg on days 1-21 and ganitumab 18 mg/kg on days 1 and 15 of a 28-day cycle). After 2 initial patients experienced dose limiting toxicity, safety stopping rules were triggered and the starting palbociclib dose was reduced to 100 mg on days 1-21 (ganitumab dose was not changed). The subsequent 7 participants were treated at the reduced starting dose (Palbociclib 100 mg on days 1-21 and ganitumab 18 mg/kg on days 1 and 15 of a 28-day cycle). This study did not include formal dose escalation given both agents had previously established recommended phase 2 dosing.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Disease Progression
|
7
|
|
Overall Study
Study closure
|
1
|
Baseline Characteristics
Palbociclib + Ganitumab In Ewing Sarcoma
Baseline characteristics by cohort
| Measure |
PALBOCICLIB and GANITUMAB
n=10 Participants
Participants receive up to 12 cycles of therapy (cycle duration=28 days).
Palbociclib: Oral, 100mg, daily on days 1-21 Ganitumab: Intravenous, 18mg/kg, days 1, 15
Per protocol, participants were monitored for dose-limiting toxicity over cycle one according to an interim safety analysis. The safety monitoring rule was triggered after 3 patients had enrolled, prompting an amendment according to Contingency Plan A which was a reduction of the palbociclib dose from 125mg (days 1-21).
|
|---|---|
|
Age, Continuous
|
25.7 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
|
Primary site at diagnosis
Bone
|
8 Participants
n=5 Participants
|
|
Primary site at diagnosis
Soft tissue
|
2 Participants
n=5 Participants
|
|
Primary site at diagnosis
Femur
|
3 Participants
n=5 Participants
|
|
Primary site at diagnosis
Iliac
|
2 Participants
n=5 Participants
|
|
Primary site at diagnosis
Gluteal soft tissue
|
2 Participants
n=5 Participants
|
|
Primary site at diagnosis
Scapula
|
1 Participants
n=5 Participants
|
|
Primary site at diagnosis
Tibia
|
1 Participants
n=5 Participants
|
|
Primary site at diagnosis
Thoracic vertebra
|
1 Participants
n=5 Participants
|
|
Translocation
EWSR1/FLI1
|
5 Participants
n=5 Participants
|
|
Translocation
EWSR1-translocation by FISH
|
5 Participants
n=5 Participants
|
|
Prior IGF - 1R therapy
No
|
10 Participants
n=5 Participants
|
|
Prior IGF - 1R therapy
Yes
|
0 Participants
n=5 Participants
|
|
Stage at diagnosis
Localized
|
4 Participants
n=5 Participants
|
|
Stage at diagnosis
Metastatic
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed up to 10.8 monthsORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Outcome measures
| Measure |
PALBOCICLIB and GANITUMAB
n=10 Participants
Participants receive up to 12 cycles of therapy (cycle duration=28 days).
Palbociclib: Oral, 100mg, daily on days 1-21 Ganitumab: Intravenous, 18mg/kg, days 1, 15
Per protocol, participants were monitored for dose-limiting toxicity over cycle one according to an interim safety analysis. The safety monitoring rule was triggered after 3 patients had enrolled, prompting an amendment according to Contingency Plan A which was a reduction of the palbociclib dose from 125mg (days 1-21).
|
|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 30.0
|
PRIMARY outcome
Timeframe: Participants were followed up to 11.8 months.The proportion of participants who experienced a maximum grade 3 or 4 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms
Outcome measures
| Measure |
PALBOCICLIB and GANITUMAB
n=10 Participants
Participants receive up to 12 cycles of therapy (cycle duration=28 days).
Palbociclib: Oral, 100mg, daily on days 1-21 Ganitumab: Intravenous, 18mg/kg, days 1, 15
Per protocol, participants were monitored for dose-limiting toxicity over cycle one according to an interim safety analysis. The safety monitoring rule was triggered after 3 patients had enrolled, prompting an amendment according to Contingency Plan A which was a reduction of the palbociclib dose from 125mg (days 1-21).
|
|---|---|
|
Grade 3/4 Treatment-Related Toxicity Rate
|
0.8 proportion of participants
Interval 0.44 to 0.97
|
SECONDARY outcome
Timeframe: Participants were followed up to 6 months.PFS6 is the percent probability estimate at 6 months based on the Kaplan-Meier method. PFS is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Outcome measures
| Measure |
PALBOCICLIB and GANITUMAB
n=10 Participants
Participants receive up to 12 cycles of therapy (cycle duration=28 days).
Palbociclib: Oral, 100mg, daily on days 1-21 Ganitumab: Intravenous, 18mg/kg, days 1, 15
Per protocol, participants were monitored for dose-limiting toxicity over cycle one according to an interim safety analysis. The safety monitoring rule was triggered after 3 patients had enrolled, prompting an amendment according to Contingency Plan A which was a reduction of the palbociclib dose from 125mg (days 1-21).
|
|---|---|
|
6-month Progression Free Survival (PFS6)
|
30 Percent Probability
Interval 1.6 to 58.4
|
SECONDARY outcome
Timeframe: Participants were followed up to 6 months.OS6 is the percent probability estimate at 6 months based on the Kaplan-Meier method. Overall survival was defined as the time from study enrollment to death. Participants alive were censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
Outcome measures
| Measure |
PALBOCICLIB and GANITUMAB
n=10 Participants
Participants receive up to 12 cycles of therapy (cycle duration=28 days).
Palbociclib: Oral, 100mg, daily on days 1-21 Ganitumab: Intravenous, 18mg/kg, days 1, 15
Per protocol, participants were monitored for dose-limiting toxicity over cycle one according to an interim safety analysis. The safety monitoring rule was triggered after 3 patients had enrolled, prompting an amendment according to Contingency Plan A which was a reduction of the palbociclib dose from 125mg (days 1-21).
|
|---|---|
|
6-month Overall Survival (OS6)
|
80 Percent Probability
Interval 55.1 to 100.0
|
Adverse Events
PALBOCICLIB and GANITUMAB
Serious events: 1 serious events
Other events: 10 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
PALBOCICLIB and GANITUMAB
n=10 participants at risk
Participants receive up to 12 cycles of therapy (cycle duration=28 days).
Palbociclib: Oral, 100mg, daily on days 1-21 Ganitumab: Intravenous, 18mg/kg, days 1, 15
Per protocol, participants were monitored for dose-limiting toxicity over cycle one according to an interim safety analysis. The safety monitoring rule was triggered after 3 patients had enrolled, prompting an amendment according to Contingency Plan A which was a reduction of the palbociclib dose from 125mg (days 1-21).
|
|---|---|
|
General disorders
Non-Cardiac Chest Patin
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
Other adverse events
| Measure |
PALBOCICLIB and GANITUMAB
n=10 participants at risk
Participants receive up to 12 cycles of therapy (cycle duration=28 days).
Palbociclib: Oral, 100mg, daily on days 1-21 Ganitumab: Intravenous, 18mg/kg, days 1, 15
Per protocol, participants were monitored for dose-limiting toxicity over cycle one according to an interim safety analysis. The safety monitoring rule was triggered after 3 patients had enrolled, prompting an amendment according to Contingency Plan A which was a reduction of the palbociclib dose from 125mg (days 1-21).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
8/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Cardiac disorders
Sinus bradycardia
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Cardiac disorders
Sinus tachycardia
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Eye disorders
Vision decreased
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
3/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
7/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
General disorders
Edema limbs
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
General disorders
Fatigue
|
70.0%
7/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
General disorders
Fever
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
General disorders
Gait disturbance
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
General disorders
Non-cardiac chest pain
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
General disorders
Pain
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Infections and infestations
Gum infection
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Injury, poisoning and procedural complications
Wound complication
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Blood bicarbonate decreased
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Creatinine increased
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Hemoglobin increased
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Investigations - Other, specify
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Lymphocyte count decreased
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Neutrophil count decreased
|
90.0%
9/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Platelet count decreased
|
90.0%
9/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
Weight loss
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Investigations
White blood cell decreased
|
100.0%
10/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
5/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.0%
3/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
30.0%
3/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Nervous system disorders
Concentration impairment
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Nervous system disorders
Muscle weakness right-sided
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Psychiatric disorders
Depression
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
4/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Vascular disorders
Hot flashes
|
10.0%
1/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
|
Vascular disorders
Hypotension
|
30.0%
3/10 • Participants were followed for AEs up to 11.8 months and survival up to 2 years.
Serious adverse events were defined per protocol section (7.6). All remaining adverse events were classified as other adverse events. Maximum grade per toxicity type is presented.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place