Trial Outcomes & Findings for Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML (NCT NCT02311998)

NCT ID: NCT02311998

Last Updated: 2023-07-17

Results Overview

Maximum tolerated dose of bosutinib defined as the highest dose level in which \< 2 patients of 6 develop first course dose limiting toxicity (Phase I). Dose levels assessed were dose 1 = 300 mg, dose 2 = 400 mg, and dose 3 = 500 mg.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

22 participants

Primary outcome timeframe

At day 28

Results posted on

2023-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 300mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 400mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 500mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO Inotuzumab Ozogamicin: Given IV
Overall Study STARTED	3	6	9	4
Overall Study COMPLETED	3	6	9	4
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase I/II Study of Bosutinib in Combination With Inotuzumab Ozogamicin in CD22-positive PC Positive ALL and CML

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 n=3 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 300mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 n=6 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 400mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 n=9 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 500mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II n=4 Participants Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO Inotuzumab Ozogamicin: Given IV	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants	1 Participants n=483 Participants	14 Participants n=36 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants	8 Participants n=36 Participants
Age, Continuous	43 years n=93 Participants	60 years n=4 Participants	63 years n=27 Participants	71 years n=483 Participants	64 years n=36 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants	2 Participants n=483 Participants	12 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	10 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants	3 Participants n=483 Participants	21 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Region of Enrollment United States	3 participants n=93 Participants	6 participants n=4 Participants	9 participants n=27 Participants	4 participants n=483 Participants	22 participants n=36 Participants

PRIMARY outcome

Timeframe: At day 28

Population: This outcome is only intended for the Phase I arm of this study

Outcome measures

Outcome measures
Measure	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 n=18 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 300mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 400mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 500mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO Inotuzumab Ozogamicin: Given IV
Maximum Tolerated Dose (MTD) of Bosutinib All Phase I Participants	400 Milligrams	—	—	—

PRIMARY outcome

Timeframe: Up to 6 years, 11 months

Major Hematologic Response i(MaHR) is defined as Complete Response (CR) + Complete Remission without Incomplete Blood Count Recovery (CRi). CR was defined as absence of circulating blasts with bone marrow blasts \<5% and recovery of neutrophil count to ≥1.0 x 10\^9/L and platelet count to ≥100 x10\^9/L. The CRi was defined as meeting criteria for CR except for neutrophil and/or platelet recovery. Response was assessed by bone marrow analysis after each cycle of therapy until attainment of CR/CRi.

Outcome measures

Outcome measures
Measure	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 n=3 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 300mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 n=6 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 400mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 n=9 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 500mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II n=4 Participants Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO Inotuzumab Ozogamicin: Given IV
Number of Participants With a Major Hematologic Response	3 Participants	4 Participants	8 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 6 years, 11 months

Population: Of the 18 participants treated during Phase I, 15 were evaluable for response.

Estimated using the method of Kaplan-Meier. Response date to loss of response or last follow up.

Outcome measures

Outcome measures
Measure	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 n=3 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 300mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 n=6 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 400mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 n=9 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 500mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II n=4 Participants Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO Inotuzumab Ozogamicin: Given IV
Duration of Response	4.1 Months Interval 1.9 to 8.8	7.7 Months Interval 6.2 to 73.8	27.2 Months Interval 2.1 to 68.9	5.1 Months Interval 0.7 to 8.1

SECONDARY outcome

Timeframe: Up to 6 years, 11 months

Estimated using the method of Kaplan-Meier. Time from date of treatment start until date of death due to any cause or last Follow-up.

Outcome measures

Outcome measures
Measure	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 n=3 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 300mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 n=6 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 400mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 n=9 Participants Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 500mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II n=4 Participants Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO Inotuzumab Ozogamicin: Given IV
Overall Survival (OS)	8.2 Months Interval 6.8 to 10.7	9.6 Months Interval 2.0 to 74.6	47.5 Months Interval 2.7 to 72.8	5.3 Months Interval 2.0 to 28.2

Adverse Events

Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1

Serious events: 3 serious events

Other events: 3 other events

Deaths: 3 deaths

Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2

Serious events: 6 serious events

Other events: 6 other events

Deaths: 5 deaths

Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3

Serious events: 5 serious events

Other events: 8 other events

Deaths: 4 deaths

Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II

Serious events: 4 serious events

Other events: 4 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 n=3 participants at risk Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 300mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 n=6 participants at risk Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 400mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 n=9 participants at risk Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 500mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II n=4 participants at risk Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO Inotuzumab Ozogamicin: Given IV
General disorders Abdominal pain	33.3% 1/3 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Immune system disorders Allergic reaction	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Gastrointestinal disorders Ascites	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	66.7% 2/3 • Number of events 3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Musculoskeletal and connective tissue disorders Bone pain	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Dehydration	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Nervous system disorders Dizziness	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Nervous system disorders Encephalopathy	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Number of events 2 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Vascular disorders Hypertension	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Vascular disorders Hypotension	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Nervous system disorders Intracranial hemorrhage	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Infections and infestations Lung infection	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	75.0% 3/4 • Number of events 5 • Up to 6 years, 11 months.
General disorders Non-cardiac chest pain	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	50.0% 2/4 • Number of events 3 • Up to 6 years, 11 months.
Infections and infestations Upper respiratory infection	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Infections and infestations Urinary tract infection	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Cardiac disorders Cardiac Arrest	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.

Other adverse events

Other adverse events
Measure	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 1 n=3 participants at risk Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 300mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 2 n=6 participants at risk Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 400mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase I Dose 3 n=9 participants at risk Patients receive bosutinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO 500mg Inotuzumab Ozogamicin: Given IV	Treatment (Bosutinib, Inotuzumab Ozogamicin) Phase II n=4 participants at risk Patients receive bosutinib at the Maximum Tolerated Dose from the Phase I dose part, PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Patients with confirmed CR, CRi, CCyR and/or absence of MRD may receive inotuzumab ozogamicin IV on day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Bosutinib: Given PO Inotuzumab Ozogamicin: Given IV
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	50.0% 3/6 • Number of events 3 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Investigations Alkaline phosphatase increased	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/3 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Ascites	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Ataxia	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Investigations Blood bilirubin increased	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Eye disorders Blurred vision	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Injury, poisoning and procedural complications Bruising	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Cardiac disorders Cardiac disorders	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Cardiac disorders Chest pain cardiac	0.00% 0/3 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
General disorders Chills	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Psychiatric disorders Confusion	0.00% 0/3 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Investigations Creatinine increased	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Gastrointestinal disorders Blisters Lip	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Psychiatric disorders Depression	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	66.7% 4/6 • Number of events 4 • Up to 6 years, 11 months.	33.3% 3/9 • Number of events 3 • Up to 6 years, 11 months.	50.0% 2/4 • Number of events 2 • Up to 6 years, 11 months.
Nervous system disorders Dizziness	0.00% 0/3 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Ear and labyrinth disorders Ear pain	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
General disorders Edema limbs	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	50.0% 3/6 • Number of events 3 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	50.0% 2/4 • Number of events 2 • Up to 6 years, 11 months.
Eye disorders Eye disorders	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
General disorders Deconditioning	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Injury, poisoning and procedural complications Fall	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
General disorders Fatigue	0.00% 0/3 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
General disorders Fever	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	50.0% 2/4 • Number of events 2 • Up to 6 years, 11 months.
General disorders Flushing	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Gastrointestinal disorders	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	50.0% 3/6 • Number of events 3 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	50.0% 2/4 • Number of events 2 • Up to 6 years, 11 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
General disorders Headache	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 3 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	50.0% 2/4 • Number of events 2 • Up to 6 years, 11 months.
Cardiac disorders Heart failure	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Gastrointestinal disorders Hemorrhoids	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders hepatosplenomegaly	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Vascular disorders Hypertension	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Metabolism and nutrition disorders Hyperuricemia	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Metabolism and nutrition disorders Hypokalemia	100.0% 3/3 • Number of events 3 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	44.4% 4/9 • Number of events 4 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Metabolism and nutrition disorders Hypomagnesemia	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Immune system disorders Immune system disorders	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Infections and infestations Lung infection	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	50.0% 2/4 • Number of events 2 • Up to 6 years, 11 months.
Nervous system disorders Memory impairment	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
General disorders mild lip swelling	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Mucositis oral	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	50.0% 3/6 • Number of events 3 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	50.0% 3/6 • Number of events 3 • Up to 6 years, 11 months.	44.4% 4/9 • Number of events 4 • Up to 6 years, 11 months.	75.0% 3/4 • Number of events 3 • Up to 6 years, 11 months.
Nervous system disorders Nervous system disorders	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
General disorders night sweats	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
General disorders Pain	0.00% 0/3 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 3 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Eye disorders Periorbital edema	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 3 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Skin and subcutaneous tissue disorders Rash maculo papular	0.00% 0/3 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 2 • Up to 6 years, 11 months.	22.2% 2/9 • Number of events 2 • Up to 6 years, 11 months.	50.0% 2/4 • Number of events 2 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	66.7% 2/3 • Number of events 2 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Sore throat	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Nervous system disorders Syncope	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Renal and urinary disorders Urinary frequency	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	25.0% 1/4 • Number of events 1 • Up to 6 years, 11 months.
Renal and urinary disorders Urinary incontinence	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/3 • Up to 6 years, 11 months.	0.00% 0/6 • Up to 6 years, 11 months.	11.1% 1/9 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Vascular disorders Vascular disorders	33.3% 1/3 • Number of events 1 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.
Gastrointestinal disorders Vomiting	66.7% 2/3 • Number of events 4 • Up to 6 years, 11 months.	33.3% 2/6 • Number of events 3 • Up to 6 years, 11 months.	44.4% 4/9 • Number of events 4 • Up to 6 years, 11 months.	50.0% 2/4 • Number of events 2 • Up to 6 years, 11 months.
Infections and infestations Wound infection	0.00% 0/3 • Up to 6 years, 11 months.	16.7% 1/6 • Number of events 1 • Up to 6 years, 11 months.	0.00% 0/9 • Up to 6 years, 11 months.	0.00% 0/4 • Up to 6 years, 11 months.

Additional Information

Nitin Jain MD/Associate Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-745-6080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place