Trial Outcomes & Findings for MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation (NCT NCT02250300)

Last Updated: 2023-03-08

Results Overview

Maximum-tolerated dose of ixazomib (MLN9708) will be determined from the incidence of dose limiting toxicities at each dosage. Results for both escalation phase cohorts (3.0 mg and 4.0 mg) were used to determine the maximum tolerated dose.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

68 participants

Primary outcome timeframe

4 weeks

Results posted on

2023-03-08

Participant Flow

Eleven of the 68 subjects consenting to participate were determined to be ineligible to participate in the study. The remaining 57 total subjects are detailed below. The initial dose of MLN9708 in the escalation phase was 3.0mg. Due to no DLTs experienced in this group, no subjects were enrolled to the lower 2.3mg cohort.

Participant milestones

Participant milestones
Measure	MLN9708 Phase II Matched Sibling Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg	MLN9708 Phase II Matched Unrelated Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg	MLN9708 Phase I (3.0 mg) Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 orally based on a dose escalation schema. MLN9708 (3.0 mg)	MLN9708 Phase I (4.0 mg) Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 orally based on a dose escalation schema. MLN9708 (4.0 mg)
Dose Escalation 3.0 mg Phase STARTED	0	0	3	0
Dose Escalation 3.0 mg Phase COMPLETED	0	0	3	0
Dose Escalation 3.0 mg Phase NOT COMPLETED	0	0	0	0
Dose Escalation 4.0 mg Phase STARTED	0	0	0	3
Dose Escalation 4.0 mg Phase COMPLETED	0	0	0	3
Dose Escalation 4.0 mg Phase NOT COMPLETED	0	0	0	0
Expansion Phase STARTED	25	26	0	0
Expansion Phase COMPLETED	19	19	0	0
Expansion Phase NOT COMPLETED	6	7	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MLN9708 Phase II Matched Sibling Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg	MLN9708 Phase II Matched Unrelated Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg	MLN9708 Phase I (3.0 mg) Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 orally based on a dose escalation schema. MLN9708 (3.0 mg)	MLN9708 Phase I (4.0 mg) Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 orally based on a dose escalation schema. MLN9708 (4.0 mg)
Expansion Phase Death	6	7	0	0

Baseline Characteristics

MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MLN9708 Phase II Matched Sibling n=25 Participants Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic hematopoietic cell transplant (HCT). MLN9708 (4.0 mg): 4.0 mg	MLN9708 Phase II Matched Unrelated n=26 Participants Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg	MLN9708 Phase I (3.0 mg) n=3 Participants Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 orally based on a dose escalation schema. MLN9708 (3.0 mg)	MLN9708 Phase I (4.0 mg) n=3 Participants Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 orally based on a dose escalation schema. MLN9708 (4.0 mg)	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	20 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	44 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Age, Continuous	54.3 years STANDARD_DEVIATION 11.3 • n=5 Participants	53.5 years STANDARD_DEVIATION 12.9 • n=7 Participants	65.3 years STANDARD_DEVIATION 0.9 • n=5 Participants	65.0 years STANDARD_DEVIATION 8.0 • n=4 Participants	53.9 years STANDARD_DEVIATION 12.2 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	17 Participants n=21 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	19 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	40 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	26 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	57 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	26 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	56 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	25 participants n=5 Participants	26 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	57 participants n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Only the subjects in the Phase I dose escalation study are included in this outcome measure.

Outcome measures

Outcome measures
Measure	Maximum Tolerated Dose of Study Drug n=6 Participants This measure is the maximum dosage of study drug based on the count of Drug Limiting Toxicities (DLT). The number of DLT for each dosage are listed in the results of Outcome Measure #3.	MLN9708 Phase II Matched Unrelated Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg
Maximum-tolerated Dose of MLN9708.	4 millligram	—

PRIMARY outcome

Timeframe: 1 year

Population: The Phase 1 dose escalation cohort is not included in this outcome measure.

The number of participants who have graft-versus-host disease. The two expansion phase cohorts (3.0 mg and 4.0 mg) were not included in this analysis.

Outcome measures

Outcome measures
Measure	Maximum Tolerated Dose of Study Drug n=25 Participants This measure is the maximum dosage of study drug based on the count of Drug Limiting Toxicities (DLT). The number of DLT for each dosage are listed in the results of Outcome Measure #3.	MLN9708 Phase II Matched Unrelated n=26 Participants Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg
Cumulative Incidence of Chronic Graft-versus-host Disease.	9 Participants	10 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Based on the escalation schema and lack of dose limiting toxicities, the 2.3mg dosage cohort was not required.

A 3+3 design will be employed. At each dose, three patients will be initially evaluated. If no dose limiting toxicities are observed, the MLN9708 dose will be increased; if one dose limiting toxicity is observed, three additional patients will be treated at that dose. A dose at which two DLTs are observed in three or six patients are judged to be too toxic, the lower dose will be defined as the maximally tolerated dose (MTD).

Outcome measures

Outcome measures
Measure	Maximum Tolerated Dose of Study Drug n=3 Participants This measure is the maximum dosage of study drug based on the count of Drug Limiting Toxicities (DLT). The number of DLT for each dosage are listed in the results of Outcome Measure #3.	MLN9708 Phase II Matched Unrelated n=3 Participants Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg
Number of Participants Experiencing Dose-limiting Toxicity of MLN9708	0 dose limiting toxicity	0 dose limiting toxicity

Adverse Events

MLN9708 Phase II Matched Sibling

Serious events: 6 serious events

Other events: 25 other events

Deaths: 6 deaths

MLN9708 Phase II Matched Unrelated

Serious events: 17 serious events

Other events: 26 other events

Deaths: 7 deaths

MLN9708 Phase I (3.0mg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

MLN9708 Phase I (4.0mg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MLN9708 Phase II Matched Sibling n=25 participants at risk Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg	MLN9708 Phase II Matched Unrelated n=26 participants at risk Phase II Patients will be enrolled in two independent cohorts of matched sibling and matched unrelated donor transplants. Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 starting on day +60 to +90 post allogeneic HCT. MLN9708 (4.0 mg): 4.0 mg	MLN9708 Phase I (3.0mg) n=3 participants at risk Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 orally based on a dose escalation schema. MLN9708 (3.0 mg)	MLN9708 Phase I (4.0mg) n=3 participants at risk Phase I Four doses of MLN9708 will be administered on days 1, 8, 15, \& 22 orally based on a dose escalation schema. MLN9708 (4.0 mg)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	7.7% 2/26 • Number of events 2 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Blood and lymphatic system disorders Hemolytic uremic syndrome	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
General disorders Fever	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Gastrointestinal disorders Diarrhea	12.0% 3/25 • Number of events 3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	7.7% 2/26 • Number of events 2 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Infections and infestations Lung infection	4.0% 1/25 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/26 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Gastrointestinal disorders Ileus	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Injury, poisoning and procedural complications Fall	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	4.0% 1/25 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	7.7% 2/26 • Number of events 2 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.
Vascular disorders Hypotension	0.00% 0/25 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	3.8% 1/26 • Number of events 1 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.	0.00% 0/3 • Adverse events were recorded for the Phase 1 cohort for four weeks. Adverse events for the remaining cohorts were collected up to one year. One subject in the Phase 1 cohort expired after the 4 week dose escalation phase but prior to the end of study data collection.

Other adverse events

Additional Information

Mehdi Hamadani, MD

Froedtert and the Medical college of Wisconsin

Phone: 414-805-4600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place