Trial Outcomes & Findings for Ixazomib Rollover Study (NCT NCT02924272)
NCT ID: NCT02924272
Last Updated: 2025-03-12
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an AE in which the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe); c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Up to 7 years
Results posted on
2025-03-12
Participant Flow
Participants took part in the study at various investigative sites globally from 16 December 2016 to 03 July 2024.
Participants who had previously received and tolerated treatment in ixazomib parent studies (C16003 \[NCT00932698\], C16005 \[NCT01217957\], C16006 \[NCT01335685\],C16007 \[NCT01318902\],C16008 \[NCT01383928\],C16010 Global \[NCT01564537\],C16011 \[NCT01659658\],C16013 \[NCT01645930\],C16014 Global \[NCT01850524\] and Korean Continuation,C16017 \[NCT01939899\],C16020 \[NCT02046070\],C16029 \[NCT03170882\], or C16047 \[NCT03439293\]), and in investigator's opinion could benefit from continued therapy were enrolled.
Participant milestones
| Measure |
Ixazomib Monotherapy
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
23
|
9
|
Reasons for withdrawal
| Measure |
Ixazomib Monotherapy
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Overall Study
Site Terminated by Sponsor
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Progressive Disease
|
11
|
8
|
|
Overall Study
Clinical Deterioration
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Reason Not Specified
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ixazomib Monotherapy
n=23 Participants
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
n=9 Participants
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.1 years
STANDARD_DEVIATION 6.45 • n=23 Participants
|
64.6 years
STANDARD_DEVIATION 9.53 • n=9 Participants
|
72.2 years
STANDARD_DEVIATION 8.73 • n=32 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=23 Participants
|
5 Participants
n=9 Participants
|
16 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=23 Participants
|
4 Participants
n=9 Participants
|
16 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to 7 yearsPopulation: Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an AE in which the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe); c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event.
Outcome measures
| Measure |
Ixazomib Monotherapy
n=23 Participants
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
n=9 Participants
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
12 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPopulation: Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5 was: death related to AE.
Outcome measures
| Measure |
Ixazomib Monotherapy
n=23 Participants
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
n=9 Participants
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Number of Participants With ≥ Grade 3 AEs
|
13 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPopulation: Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
Severity grade was evaluated based on CTCAE version 5.0. Grade 2: moderate symptoms; limiting instrumental activities of daily living. Grade 3: severe or medically significant; limiting self-care activities of daily living. Grade 4: life threatening consequences; urgent intervention indicated.
Outcome measures
| Measure |
Ixazomib Monotherapy
n=23 Participants
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
n=9 Participants
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Number of Participants With ≥ Grade 2 Peripheral Neuropathy
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPopulation: Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
Outcome measures
| Measure |
Ixazomib Monotherapy
n=23 Participants
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
n=9 Participants
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Number of Participants With New Primary Malignancies
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPopulation: Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product.
Outcome measures
| Measure |
Ixazomib Monotherapy
n=23 Participants
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
n=9 Participants
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug
AE Resulting in Dose Modification
|
12 Participants
|
7 Participants
|
|
Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug
AE Resulting in Discontinuation of Study Drug
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 7 yearsPopulation: Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. Any AE interpreted by the investigator as a clinically significant event was reported.
Outcome measures
| Measure |
Ixazomib Monotherapy
n=23 Participants
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
n=9 Participants
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Number of Participants With Any Other AE That in the Opinion of the Investigator is a Clinically Significant Event
|
15 Participants
|
7 Participants
|
Adverse Events
Ixazomib Monotherapy
Serious events: 12 serious events
Other events: 9 other events
Deaths: 1 deaths
Ixazomib Combination Therapy
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixazomib Monotherapy
n=23 participants at risk
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
n=9 participants at risk
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Nervous system disorders
Balance disorder
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Bronchiolitis
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Cardiac disorders
Cardiac failure
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Cardiac disorders
Cardiac failure congestive
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Nervous system disorders
Ischaemic stroke
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Osteomyelitis
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Pneumonia
|
8.7%
2/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
33.3%
3/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sebaceous carcinoma
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Tuberculous pleurisy
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
Other adverse events
| Measure |
Ixazomib Monotherapy
n=23 participants at risk
Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.
|
Ixazomib Combination Therapy
n=9 participants at risk
Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
33.3%
3/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
8.7%
2/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
22.2%
2/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
COVID-19
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
2/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Vascular disorders
Hypertension
|
17.4%
4/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
2/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
11.1%
1/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
3/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
33.3%
3/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
0.00%
0/9 • Up to 7 years
The Safety Population included all enrolled participants who received at least 1 dose of ixazomib.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place