Trial Outcomes & Findings for Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib (NCT NCT04079738)
NCT ID: NCT04079738
Last Updated: 2023-09-13
Results Overview
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose(s) (RP2D) of the combination of TAK-659 and Ixazomib in patients with relapsed or refractory AML.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
At the end of Cycle 2(each cycle is 28 days)
Results posted on
2023-09-13
Participant Flow
Participant milestones
| Measure |
Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg
Phase I,Level 1: TAK-659 100mg (Days 1-15) + Ixazomib 2.3mg dose escalation (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg of TAK-659 tablets once daily for fifteen days.
Ixazomib: Subjects were given 2.3 mg of Ixazomib capsules once weekly on days 1, 8,15, respectively.
|
Phase I, Level 2: TAK-659 100mg + Ixazomid 3mg
Phase I,Level 2: TAK-659 100mg (Days 1-15) + Ixazomib 3mg dose escalation (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg of TAK-659 tablets once daily for fifteen days.
Ixazomib: Subjects were given 3 mg of Ixazomib capsules once weekly on days 1, 8,15, respectively.
|
Phase I, Level 3: TAK-659 100mg + Ixazomid 4mg
Phase I, Level 3: TAK-659 100mg (Days 1-15) + Ixazomib 4mg dose escalation (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg of TAK-659 tablets once daily for fifteen days.
Ixazomib: Subjects were given 4 mg of Ixazomib capsules once weekly on days 1, 8,15, respectively.
|
Phase II:TAK-659 100mg+ Ixazomib MTD
Phase II: TAK-659 100 mg (Days 1-15) + Ixazomib at MTD (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg ofTAK-659 tablets once daily for fifteen days at MTD.
Ixazomib: Subjects were given Ixazomib capsules once weekly at MTD on days 1, 8,15, respectively at MTD.
|
|---|---|---|---|---|
|
Study Treatment
STARTED
|
8
|
0
|
0
|
0
|
|
Study Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
|
Study Treatment
NOT COMPLETED
|
8
|
0
|
0
|
0
|
|
Follow up
STARTED
|
8
|
0
|
0
|
0
|
|
Follow up
COMPLETED
|
0
|
0
|
0
|
0
|
|
Follow up
NOT COMPLETED
|
8
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg
Phase I,Level 1: TAK-659 100mg (Days 1-15) + Ixazomib 2.3mg dose escalation (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg of TAK-659 tablets once daily for fifteen days.
Ixazomib: Subjects were given 2.3 mg of Ixazomib capsules once weekly on days 1, 8,15, respectively.
|
Phase I, Level 2: TAK-659 100mg + Ixazomid 3mg
Phase I,Level 2: TAK-659 100mg (Days 1-15) + Ixazomib 3mg dose escalation (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg of TAK-659 tablets once daily for fifteen days.
Ixazomib: Subjects were given 3 mg of Ixazomib capsules once weekly on days 1, 8,15, respectively.
|
Phase I, Level 3: TAK-659 100mg + Ixazomid 4mg
Phase I, Level 3: TAK-659 100mg (Days 1-15) + Ixazomib 4mg dose escalation (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg of TAK-659 tablets once daily for fifteen days.
Ixazomib: Subjects were given 4 mg of Ixazomib capsules once weekly on days 1, 8,15, respectively.
|
Phase II:TAK-659 100mg+ Ixazomib MTD
Phase II: TAK-659 100 mg (Days 1-15) + Ixazomib at MTD (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg ofTAK-659 tablets once daily for fifteen days at MTD.
Ixazomib: Subjects were given Ixazomib capsules once weekly at MTD on days 1, 8,15, respectively at MTD.
|
|---|---|---|---|---|
|
Study Treatment
Death
|
1
|
0
|
0
|
0
|
|
Study Treatment
Adverse Event
|
2
|
0
|
0
|
0
|
|
Study Treatment
withdrawal before treatment
|
1
|
0
|
0
|
0
|
|
Study Treatment
symptomatic deterioration
|
2
|
0
|
0
|
0
|
|
Study Treatment
Disease Progression
|
1
|
0
|
0
|
0
|
|
Study Treatment
withdrawal after treatment
|
1
|
0
|
0
|
0
|
|
Follow up
Withdrawal by Subject
|
3
|
0
|
0
|
0
|
|
Follow up
Death
|
5
|
0
|
0
|
0
|
Baseline Characteristics
Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib
Baseline characteristics by cohort
| Measure |
Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg
n=7 Participants
Phase I,Level 1: TAK-659 100mg (Days 1-15) + Ixazomib 2.3mg dose escalation (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg of TAK-659 tablets once daily for fifteen days.
Ixazomib: Subjects were given 2.3 mg of Ixazomib capsules once weekly on days 1, 8,15, respectively.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
0 Participants
n=5 Participants
|
|
ECOG PS at screening
1
|
3 Participants
n=5 Participants
|
|
ECOG PS at screening
0
|
4 Participants
n=5 Participants
|
|
Cigarette Usage
Never a smoker
|
5 Participants
n=5 Participants
|
|
Cigarette Usage
Former smoker
|
2 Participants
n=5 Participants
|
|
Cigarette Usage
Current smoker
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of Cycle 2(each cycle is 28 days)To determine the maximum tolerated dose (MTD) and recommended phase 2 dose(s) (RP2D) of the combination of TAK-659 and Ixazomib in patients with relapsed or refractory AML.
Outcome measures
| Measure |
Phase I: TAK-659 100mg + Ixazomid 2.3mg
n=8 Participants
TAK-659 100mg + Ixazomib 2.3mg
TAK-659: Subjects were given 100 mg ofTAK-659 tablets once daily for fifteen days at MTD.
Ixazomib: Subjects were given Ixazomib capsules 2.3 mg, on days 1,8,15
|
|---|---|
|
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose(s) (RP2D)
|
NA mg
Maximum Tolerated Dose (MTD) was not determined due to the early termination of the trial by the funder. All subjects were treated with the first dose level.
|
PRIMARY outcome
Timeframe: Overall Response rate is assessed at the end of 4 cycles ; 4 months.Population: This study was terminated due to Funder's decision at Phase I.
To evaluate preliminary efficacy of TAK-659 plus Ixazomib in relapsed or refractory AML as measured by overall response rate (ORR). Overall response rate (ORR) defined as CR, CRp, CRi, and PR per Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to two years after the date of the first documented response.Population: The study was terminated at phase I due to Funder's decision.
DOR defined as the time from the date of first documentation of a response to the date of first documented progressive disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: time from first dose of study drug until tumor progression up to two years after the date of the first documented response.Population: The study was terminated at Phase I due to Funder's decision
TTP defined as the time from first dose of study drug until tumor progression as defined by the Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: time from the date of study entry up to two years.Population: This study was terminated at Phase I due to funder's decision
OS defined as the time from the date of study entry to death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of first dose until 30 days after the last treatment up to 1 year.Population: This study was terminated at Phase I due to funder's decision
Summarize Grade 3 and higher adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment up to 2 years or until death.Population: This study was terminated at Phase I due to funder's decision
Number of deaths at 3 and 6 moths are assessed in Phase II subjects.
Outcome measures
Outcome data not reported
Adverse Events
Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg
Serious events: 5 serious events
Other events: 7 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg
n=7 participants at risk
Phase I,Level 1: TAK-659 100mg (Days 1-15) + Ixazomib 2.3mg dose escalation (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg of TAK-659 tablets once daily for fifteen days.
Ixazomib: Subjects were given 2.3 mg of Ixazomib capsules once weekly on days 1, 8,15, respectively.
|
|---|---|
|
General disorders
DEATH NOS
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
28.6%
2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Cardiac disorders
HEART FAILURE
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Infections and infestations
LUNG INFECTION
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Infections and infestations
SEPSIS
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
Other adverse events
| Measure |
Phase I, Level 1: TAK-659 100mg + Ixazomid 2.3mg
n=7 participants at risk
Phase I,Level 1: TAK-659 100mg (Days 1-15) + Ixazomib 2.3mg dose escalation (Days 1, 8, 15)
TAK-659: Subjects were given 100 mg of TAK-659 tablets once daily for fifteen days.
Ixazomib: Subjects were given 2.3 mg of Ixazomib capsules once weekly on days 1, 8,15, respectively.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Blood and lymphatic system disorders
ANEMIA
|
57.1%
4/7 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
28.6%
2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Infections and infestations
BACTEREMIA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Blood and lymphatic system disorders
BLOOD AND LYMPHATIC SYSTEM DISORDERS
|
28.6%
2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
14.3%
1/7 • Number of events 5 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
14.3%
1/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Gastrointestinal disorders
CONSTIPATION
|
14.3%
1/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
General disorders
EDEMA FACE
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
General disorders
FEVER
|
28.6%
2/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Vascular disorders
FLUSHING
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
General disorders
GENERALIZED EDEMA
|
28.6%
2/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
GGT INCREASED
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Renal and urinary disorders
HEMATURIA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Endocrine disorders
HYPERPARATHYROIDISM
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Vascular disorders
HYPERTENSION
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Vascular disorders
HYPOTENSION
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKEMIA SECONDARY TO ONCOLOGY CHEMOTHERAPY
|
28.6%
2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
14.3%
1/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Gastrointestinal disorders
LIP PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
LIPASE INCREASED
|
28.6%
2/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
LYMPHOCYTE COUNT INCREASED
|
42.9%
3/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
42.9%
3/7 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Gastrointestinal disorders
NAUSEA
|
28.6%
2/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
42.9%
3/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Gastrointestinal disorders
ORAL PAIN
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
14.3%
1/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Eye disorders
PERIORBITAL EDEMA
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
PLATELET COUNT DECREASED
|
42.9%
3/7 • Number of events 4 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Infections and infestations
SEPSIS
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Investigations
SERUM AMYLASE INCREASED
|
28.6%
2/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
28.6%
2/7 • Number of events 3 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
|
Gastrointestinal disorders
VOMITING
|
14.3%
1/7 • Number of events 2 • Adverse events (AEs) were recorded from the time of consent and for at least 30 days after treatment discontinuation, regardless of whether or not the event(s) were considered related to trial medications. Serious adverse events were reported from the initiation of study drug(s) and for 30 days after administration of the last dose of study drug(s).
Adverse events were collected from the date of first treatment dose until 30 days after the last treatment, assessed for 7 cycles of treatment. Each treatment cycle was of 28 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place