Trial Outcomes & Findings for Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL (NCT NCT04624633)
NCT ID: NCT04624633
Last Updated: 2025-02-27
Results Overview
The CR Rate is defined as the proportion of participants achieving complete remission (CR) based on 2018 IW-CLL criteria.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
According to this endpoint is after 24 cycles. Overall median number of cycles is 24 with range 1-25.
Results posted on
2025-02-27
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Relapsed Disease
Participants with relapsed disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
Cohort 2 - Treatment Naive
Participants with previously untreated disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
21
|
|
Overall Study
COMPLETED
|
7
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1 - Relapsed Disease
Participants with relapsed disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
Cohort 2 - Treatment Naive
Participants with previously untreated disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
|---|---|---|
|
Overall Study
Subject Needed Surgery, Radiation or Other Therapy
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL
Baseline characteristics by cohort
| Measure |
Cohort 1 - Relapsed Disease
n=8 Participants
Participants with relapsed disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
Cohort 2 - Treatment Naive
n=21 Participants
Participants with previously untreated disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
67 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: According to this endpoint is after 24 cycles. Overall median number of cycles is 24 with range 1-25.Population: Patients who completed 24 cycle of treatment.
The CR Rate is defined as the proportion of participants achieving complete remission (CR) based on 2018 IW-CLL criteria.
Outcome measures
| Measure |
Cohort 1 - Relapsed Disease
n=6 Participants
Participants with relapsed disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
Cohort 2 - Treatment Naive
n=14 Participants
Participants with previously untreated disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
|---|---|---|
|
Complete Remission (CR) Rate After 24 Cycles
|
0.33 proportion of participants
Interval 0.043 to 0.777
|
0.29 proportion of participants
Interval 0.084 to 0.582
|
SECONDARY outcome
Timeframe: According to this endpoint is after 24 cycles. Overall median number of cycles is 24 with range 1-25.The PR Rate is defined as the proportion of participants achieving partial remission (PR) based on 2018 IW-CLL criteria.
Outcome measures
| Measure |
Cohort 1 - Relapsed Disease
n=6 Participants
Participants with relapsed disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
Cohort 2 - Treatment Naive
n=14 Participants
Participants with previously untreated disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
|---|---|---|
|
Partial Remission (PR) Rate After 24 Cycles
|
0.66 proportion of participants
Interval 0.22 to 0.88
|
0.57 proportion of participants
Interval 0.29 to 0.77
|
SECONDARY outcome
Timeframe: Disease will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. Observation on treatment up to approximately 25 cycles. In long-term follow-up, survival follow-up up to 5 years.Progression-free survival based on the Kaplan-Meier method is defined as the duration between randomization and documented disease progression (PD) or death, or is censored at time of last dsease assessment.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 - Relapsed Disease
Serious events: 7 serious events
Other events: 8 other events
Deaths: 1 deaths
Cohort 2 - Treatment Naive
Serious events: 16 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - Relapsed Disease
n=8 participants at risk
Participants with relapsed disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
Cohort 2 - Treatment Naive
n=21 participants at risk
Participants with previously untreated disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Infections and infestations
Lung infection
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
23.8%
5/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
19.0%
4/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Neutrophil count decreased
|
62.5%
5/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
28.6%
6/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Weight loss
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
Other adverse events
| Measure |
Cohort 1 - Relapsed Disease
n=8 participants at risk
Participants with relapsed disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
Cohort 2 - Treatment Naive
n=21 participants at risk
Participants with previously untreated disease
* Treatment with Acalabrutinib \& Umbralisib beginning C1D1,
* Ublituximab beginning C7D1
* Assessment of treatment response
* Treatment continues for a maximum of 24 cycles. Participants followed post treatment for a maximum of 5 years
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Cardiac disorders
Chest pain - cardiac
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Cardiac disorders
Sinus bradycardia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Cardiac disorders
Sinus tachycardia
|
37.5%
3/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Eye disorders
Cataract
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
General disorders
Edema limbs
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
General disorders
Fever
|
25.0%
2/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
General disorders
Generalized edema
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
General disorders
Pain
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Infections and infestations
Conjunctivitis
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
50.0%
4/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
57.1%
12/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Blood lactate dehydrogenase increased
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Creatinine increased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
19.0%
4/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Investigations
Weight loss
|
37.5%
3/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
23.8%
5/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
19.0%
4/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
25.0%
2/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Nervous system disorders
Extrapyramidal disorder
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Renal and urinary disorders
Chronic kidney disease
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Renal and urinary disorders
Urinary frequency
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
19.0%
4/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
4/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
33.3%
7/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
0.00%
0/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
19.0%
4/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
12.5%
1/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Vascular disorders
Hypertension
|
25.0%
2/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
14.3%
3/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Vascular disorders
Hypotension
|
25.0%
2/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
9.5%
2/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/8 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
4.8%
1/21 • Adverse events (AE) will be evaluated through imaging at cycle 1 day 1, 8, and 15, cycle 2-6 and cycle 8-25 day 1, and cycle 7 day 1, 2 and 8. AE observation on treatment up to approximately 25 cycles.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place