Trial Outcomes & Findings for Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia (NCT NCT03735875)
NCT ID: NCT03735875
Last Updated: 2024-09-19
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2024-09-19
Participant Flow
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. This study did not move on to the Phase II portion of the study. Therefore, no patients were accrued on the Phase II portion of the study.
Participant milestones
| Measure |
Phase I: Dose Level 0
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
Phase II: Treatment (Venetoclax, Quizartinib)
Patients will be treated at the established dose from the phase I portion of the study.
Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
0
|
|
Overall Study
COMPLETED
|
8
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Phase I: Dose Level 0
n=8 Participants
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
Phase II: Treatment (Venetoclax, Quizartinib)
Patients will be treated at the established dose from the phase I portion of the study.
Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
—
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
n=5 Participants
|
—
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
—
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
—
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. This study did not move on to the Phase II portion of the study. Therefore, no patients were accrued on the Phase II portion of the study.
Outcome measures
| Measure |
Phase I: Treatment (Venetoclax, Quizartinib)
n=8 Participants
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|
|
Maximum Tolerated Dose (MTD) as Determined by Dose Limiting Toxicity (Phase Ib)
|
30 Milligrams (mg)
|
SECONDARY outcome
Timeframe: Up to 4 years, 6 monthsPopulation: All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. This study did not move on to the Phase II portion of the study. Therefore, no patients were accrued on the Phase II portion of the study.
Response date to loss of response or last follow up.
Outcome measures
| Measure |
Phase I: Treatment (Venetoclax, Quizartinib)
n=8 Participants
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|
|
Duration of Response (DOR) (Phase Ib)
|
1.5 Months
Interval 0.4 to 2.3
|
SECONDARY outcome
Timeframe: Up to 4 years, 6 monthsPopulation: All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. This study did not move on to the Phase II portion of the study. Therefore, no patients were accrued on the Phase II portion of the study.
Time from date of treatment start until the date of progression or death from leukemia.
Outcome measures
| Measure |
Phase I: Treatment (Venetoclax, Quizartinib)
n=8 Participants
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|
|
Progression Free Survival (PFS) (Phase Ib)
|
2.3 Months
Interval 1.6 to 3.4
|
SECONDARY outcome
Timeframe: Up to 4 years, 6 monthsPopulation: All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. This study did not move on to the Phase II portion of the study. Therefore, no patients were accrued on the Phase II portion of the study.
Time from date of treatment start until the date of failure or death from any cause.
Outcome measures
| Measure |
Phase I: Treatment (Venetoclax, Quizartinib)
n=8 Participants
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|
|
Event-free Survival (EFS) (Phase Ib)
|
2.3 Months
Interval 1.6 to 3.4
|
SECONDARY outcome
Timeframe: Up to 4 years, 6 monthsPopulation: All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. This study did not move on to the Phase II portion of the study. Therefore, no patients were accrued on the Phase II portion of the study.
Time from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Phase I: Treatment (Venetoclax, Quizartinib)
n=8 Participants
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|
|
Overall Survival (OS) (Phase Ib)
|
3.7 Months
Interval 2.1 to 9.0
|
SECONDARY outcome
Timeframe: Up to 4 years, 6 monthsPopulation: All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. This study did not move on to the Phase II portion of the study. Therefore, no patients were accrued on the Phase II portion of the study.
Participants who achieve an adequate response (OR) who proceed to receive a HSCT.
Outcome measures
| Measure |
Phase I: Treatment (Venetoclax, Quizartinib)
n=8 Participants
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|
|
Number of Patients Bridged to Hematopoietic Stem Cell Transplant (HSCT) (Phase Ib)
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 years, 6 monthsPopulation: All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. This study did not move on to the Phase II portion of the study. Therefore, no patients were accrued on the Phase II portion of the study.
Response is defined as Complete Remission (CR), Complete Remission with Incomplete Platelet Recovery (CRp) + Complete Remission with Incomplete Hematological Recovery (CRi). CR is bone marrow regenerating normal hematopoietic cells and achieve a morphologic leukemia-free state and must have an ANC \> 1 x 10\^9/L and platelet count \>/= 100 x 10\^9/L, and normal marrow differential with \< 5% blasts, and patients will be red blood cell (RBC) and platelet transfusion independent and no evidence of extramedullary leukemia. CRp is CR except for incomplete platelet recovery (\< 100 × 10\^9/L). CRi i sbone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25% and meet the criteria for CR.
Outcome measures
| Measure |
Phase I: Treatment (Venetoclax, Quizartinib)
n=8 Participants
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|
|
Number of Participants With a Response CR, CRp + CRi
|
4 Participants
|
Adverse Events
Phase I: Dose Level 0
Serious events: 7 serious events
Other events: 8 other events
Deaths: 2 deaths
Phase II: Treatment (Venetoclax, Quizartinib)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Dose Level 0
n=8 participants at risk
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
Phase II: Treatment (Venetoclax, Quizartinib)
Patients will be treated at the established dose from the phase I portion of the study.
Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Infections and infestations
Lung infection
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
Other adverse events
| Measure |
Phase I: Dose Level 0
n=8 participants at risk
Dose finding: Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
Phase II: Treatment (Venetoclax, Quizartinib)
Patients will be treated at the established dose from the phase I portion of the study.
Patients receive quizartinib PO QD on days 1-28 and venetoclax PO QD beginning on day 8 of cycle 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue treatment beyond 24 cycles at the discretion of the treating physician.
Quizartinib: Given PO
Venetoclax: Given PO
|
|---|---|---|
|
General disorders
Abdominal pain
|
25.0%
2/8 • Number of events 2 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Immune system disorders
Allergic reaction
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Infections and infestations
Appendicitis
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Eye disorders
Blurred vision
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Gastrointestinal disorders
Colitis
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Ear and labyrinth disorders
Ear Pain
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Gastrointestinal disorders
Esophagitis
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
37.5%
3/8 • Number of events 3 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
General disorders
Fever
|
25.0%
2/8 • Number of events 2 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
37.5%
3/8 • Number of events 3 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
62.5%
5/8 • Number of events 5 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Nervous system disorders
Paresthesia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Eye disorders
Periorbital edema
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Eye disorders
Photophobia
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Infections and infestations
Sepsis
|
25.0%
2/8 • Number of events 2 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
37.5%
3/8 • Number of events 3 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Infections and infestations
Skin infection
|
25.0%
2/8 • Number of events 2 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 2 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Infections and infestations
Lung Infection
|
25.0%
2/8 • Number of events 2 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Infections and infestations
Urinary Tract Infection
|
25.0%
2/8 • Number of events 2 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Skin and subcutaneous tissue disorders
Rash Pustular
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
General disorders
Facial Pain
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
General disorders
Neck Pain
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
General disorders
Non-Cardiac Chest Pain
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
12.5%
1/8 • Number of events 1 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
—
0/0 • Up to 4 years, 6 months
All participants in the Phase I portion of this study were treated at dose level 0, therefore there was only one treatment arm for this study. The study did not go on to the Phase II portion of the study. Zero participants were registered in Phase II, therefore the number of participants at risk for Serious Adverse Events, All-Cause Mortality and Other (Not Including Serious) Adverse Events is zero.
|
Additional Information
Naval Daver, MD./Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-4392
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place