Trial Outcomes & Findings for Determining the Feasibility of MLN9708 as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma (NCT NCT02168101)

Last Updated: 2020-02-27

Results Overview

The maximum tolerated dose (MTD) of MLN9708 will be determined as the dose at which ≤1 of 6 patients experiences a DLT during one cycle (28 days) of therapy utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Collected from day of first dose to the end of the first treatment cycle, up to 28 days

Results posted on

2020-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	MLN9708 - 2.3 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
Overall Study STARTED	3	3	3
Overall Study COMPLETED	1	1	2
Overall Study NOT COMPLETED	2	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MLN9708 - 2.3 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
Overall Study Death	2	2	1

Baseline Characteristics

Determining the Feasibility of MLN9708 as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MLN9708 - 2.3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	Total n=9 Participants Total of all reporting groups
Age, Continuous	57 years n=99 Participants	47 years n=107 Participants	44 years n=206 Participants	47 years n=7 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	6 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	3 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	8 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment United States	3 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	9 Participants n=7 Participants

PRIMARY outcome

Timeframe: Collected from day of first dose to the end of the first treatment cycle, up to 28 days

Population: All patients who received at least one dose of MLN9708.

Outcome measures

Outcome measures
Measure	MLN9708 - 2.3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
Number of Phase I Patients Receiving 2.3mg, 3mg, or 4mg MLN9708 Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Maximum Tolerated Dose	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Defined as the time from Day 1 of study drug administration until 30 days after treatment completion for up to 2 years.

Population: All patients who received at least one dose of MLN9708.

Defined as the number of participants with treatment-emergent grade 3/4/5 adverse events/serious adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0 determined to be related to MLN9708.

Outcome measures

Outcome measures
Measure	MLN9708 - 2.3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety of MLN9708 When Used as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma Multiple Myeloma	1 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: every 8 weeks for approximately 24 weeks then every 3 months thereafter for 2 years

Population: All patients with measurable or evaluable disease at baseline who receive at least 1 dose of MLN9708 and undergo at least one post-baseline disease assessment. Pre-specified in Protocol to calculate PFS for all participants and for all patients receiving the MTD. Because the MTD was not reached, this analysis was only performed on all participants.

PFS is measured from the date of first protocol treatment until date of disease progression or death occurs, or date of last adequate tumor assessment using the International Myeloma Working Group Uniform Response Criteria. IMWG disease progression is defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: 1) serum M-protein, 2) urine M-protein, 3) only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels, 4) Bone marrow plasma cell percentage (absolute % must be ≥10%). OR Disease progression also could include development of new lytic bone lesions or increase from baseline in size of lytic bone lesion(s); development of new soft tissue plasmacytoma(s) or definite increase from nadir in existing soft tissue plasmacytomas; or development of hypercalcemia

Outcome measures

Outcome measures
Measure	MLN9708 - 2.3 mg n=8 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
Median Progression-Free Survival (PFS) at 2 Years Post-maintenance Therapy	6.5 months Interval 1.9 to 21.7	—	—

SECONDARY outcome

Timeframe: every 8 weeks for approximately 24 weeks after ASCT, then every 3 months thereafter for 2 years.

Overall survival is measured as the interval from first study treatment until date of death, or date last known alive.

Outcome measures

Outcome measures
Measure	MLN9708 - 2.3 mg n=8 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
Median Overall Survival (OS) at 2 Years Post-allogeneic Stem Cell Transplant (ASCT)	NA months Interval 6.1 to Not reached at this time.	—	—

SECONDARY outcome

Timeframe: from date of enrollment every 28 days, up to 2 years

Incidence of chronic Graft-versus-host disease GVHD was assessed based on the National Institutes of Health Consensus Development Project on Criteria for Clinical trials in Acute and Chronic Graft-versus-host-disease (Filipovich et al. 2005) from date of randomization until date of first documented progression, or date of death from any cause.

Outcome measures

Outcome measures
Measure	MLN9708 - 2.3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
Number of Participants With Incidence of Chronic Graft-versus-host Disease (cGVHD) After Receiving Allogeneic Stem Cell Transplant and Maintenance With MLN9708	2 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: from date of enrollment every 28 days, up to 2 years

Incidence of acute Graft-versus-host disease GVHD was assessed based on the National Institutes of Health Consensus Development Project on Criteria for Clinical trials in Acute and Chronic Graft-versus-host-disease (Przepiorka et al. 1995) from date of randomization until date of first documented progression, or date of death from any cause.

Outcome measures

Outcome measures
Measure	MLN9708 - 2.3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg n=3 Participants Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
Number of Participants With Incidence of Acute Graft-versus-host Disease (aGVHD) After Receiving Allogeneic Stem Cell Transplant and Maintenance With MLN9708	2 Participants	2 Participants	2 Participants

Adverse Events

MLN9708 - 2.3 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

MLN9708 - 3 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

MLN9708 - 4 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	MLN9708 - 2.3 mg n=3 participants at risk Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 2.3 mg of MLN9708 orally (PO) on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 3 mg n=3 participants at risk Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 3 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.	MLN9708 - 4 mg n=3 participants at risk Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive a weekly dose of 4 mg of MLN9708 on Days 1, 8, and 15 of each 28-day cycle for 6 cycles.
General disorders Pyrexia	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	66.7% 2/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.
Immune system disorders Graft Versus Host Disease	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	33.3% 1/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.	0.00% 0/3 • Adverse event data was collected from the start of study treatment, until 30 calendar days after discontinuation or completion of study treatment. All AEs resulting in discontinuation from the study treatment were followed until resolution or stabilization. After 30 days of completion of protocol-specific treatment or discontinuation, only AEs, SAEs, or deaths assessed by the Investigator as treatment related were reported. Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study treatment.

Other adverse events

Additional Information

Sarah Cannon

Sarah Cannon Development Innovations, LLC

Phone: 844-710-6157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60