Trial Outcomes & Findings for A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer (NCT NCT03131206)
NCT ID: NCT03131206
Last Updated: 2021-09-27
Results Overview
The maximally administered dose (MAD) of the study medication will be defined as the dose level where at least two subjects develop toxicities consistent with a DLT definition. In this situation, the dose level immediately below the MAD will be defined as the MTD.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
28 Days
Results posted on
2021-09-27
Participant Flow
The Phase 1 portion of the study includes 3 dose levels that can be explored: Dose Level 1 (starting dose), Dose Level -1, and Dose Level 2. This study enrolled only to Dose Level 1, therefore the baseline and outcome measures presented are for the DL1 participants only.
Participant milestones
| Measure |
Phase 1 RP2D of Alectinib
Alectinib will be administered orally twice daily. A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
|
Phase 2 Cohort A
Participants with RET-positive NSCLC with no previous history of RET-TKI therapy.
|
Phase 2 Cohort B
Participants with RET-positive NSCLC with previous history of RET-TKI therapy.
|
Phase 2 Cohort C
Participants with RET-positive thyroid cancer
|
|---|---|---|---|---|
|
Dose Level 1 (600mg BID 7d, 900mg BID)
STARTED
|
5
|
0
|
0
|
0
|
|
Dose Level 1 (600mg BID 7d, 900mg BID)
COMPLETED
|
5
|
0
|
0
|
0
|
|
Dose Level 1 (600mg BID 7d, 900mg BID)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 2 (900mg BID 7d, 1200mg BID)
STARTED
|
0
|
0
|
0
|
0
|
|
Dose Level 2 (900mg BID 7d, 1200mg BID)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Dose Level 2 (900mg BID 7d, 1200mg BID)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 RP2D of Alectinib
n=5 Participants
Dose Level 1 (starting dose)
|
Phase 2 Cohort A
Participants with RET-positive NSCLC with no previous history of RET-TKI therapy.
|
Phase 2 Cohort B
Participants with RET-positive NSCLC with previous history of RET-TKI therapy.
|
Phase 2 Cohort C
Participants with RET-positive thyroid cancer
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
—
|
—
|
—
|
60 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
—
|
—
|
—
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
—
|
—
|
—
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
—
|
—
|
—
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
—
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
—
|
—
|
—
|
5 participants
n=21 Participants
|
|
Mutation status
RET-rearranged NSCLC
|
4 participants
n=5 Participants
|
—
|
—
|
—
|
4 participants
n=21 Participants
|
|
Mutation status
ALK-rearranged NSCLC
|
1 participants
n=5 Participants
|
—
|
—
|
—
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: 5 patients were analyzed for the MTD, but the MTD was not reached due to incomplete enrollment (6 patients required to evaluate MTD, per protocol; study closed to enrollment after 5 participants were enrolled). There were no participants analyzed in the Phase 2 portion of the study (Cohorts A, B, and C), hence why those fields are NA.
The maximally administered dose (MAD) of the study medication will be defined as the dose level where at least two subjects develop toxicities consistent with a DLT definition. In this situation, the dose level immediately below the MAD will be defined as the MTD.
Outcome measures
| Measure |
Phase 1 RP2D of Alectinib
n=5 Participants
The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have NSCLC, not everyone who participates in this research study will receive the same dose of the study drug. The dosage will depend on the number of participants who have been enrolled in the study and how well the dosage has been tolerated.
* Alectinib
* Oral, BID
* A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
Cohort A
Participants with RET-rearranged NSCLC with no previous history of RET-TKI therapy.
* Alectinib
* Oral, BID, participants will receive the RP2D identified during Phase 1.
* Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
Cohort B
Participants with RET-rearranged NSCLC with previous history of RET-TKI therapy.
* Alectinib
* Oral, BID, participants will receive the RP2D identified during Phase 1.
* Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
Cohort C
Participants with RET-rearranged thyroid cancer
* Alectinib
* Oral, BID, participants will receive the RP2D identified during Phase 1.
* Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (Phase 1)
|
NA mg
MTD could not be evaluated as only 5 subjects were enrolled; per protocol, 6 subjects are required to evaluate MTD.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Five participants were enrolled to the Phase 1 portion of the study and had imaging assessments performed; these 5 participants were evaluable for response rate.
Preliminary evaluation of objective response rate (ORR) of alectinib was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase 1 RP2D of Alectinib
n=5 Participants
The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have NSCLC, not everyone who participates in this research study will receive the same dose of the study drug. The dosage will depend on the number of participants who have been enrolled in the study and how well the dosage has been tolerated.
* Alectinib
* Oral, BID
* A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
Cohort A
Participants with RET-rearranged NSCLC with no previous history of RET-TKI therapy.
* Alectinib
* Oral, BID, participants will receive the RP2D identified during Phase 1.
* Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
Cohort B
Participants with RET-rearranged NSCLC with previous history of RET-TKI therapy.
* Alectinib
* Oral, BID, participants will receive the RP2D identified during Phase 1.
* Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
Cohort C
Participants with RET-rearranged thyroid cancer
* Alectinib
* Oral, BID, participants will receive the RP2D identified during Phase 1.
* Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
|---|---|---|---|---|
|
Objective Response Rate
|
20 percentage of participants
Interval 0.52 to 71.63
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data not collected. Trial terminated early due to slow accrual.
AUC pharmacokinetic parameters will be estimated using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. Results are incomplete because study closed to accrual early.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 YearsPopulation: Data not collected. Trial terminated early due to slow accrual.
Progression evaluated using RECIST 1.1 Criteria. Results are incomplete because study closed to accrual early.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: OS was calculated at the time of analysis, which was approximately 22 months after the study opened to enrollment.Population: Number of participants alive at time of analysis.
Overall survival is recorded from start of enrollment through study completion.
Outcome measures
| Measure |
Phase 1 RP2D of Alectinib
n=5 Participants
The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have NSCLC, not everyone who participates in this research study will receive the same dose of the study drug. The dosage will depend on the number of participants who have been enrolled in the study and how well the dosage has been tolerated.
* Alectinib
* Oral, BID
* A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
Cohort A
Participants with RET-rearranged NSCLC with no previous history of RET-TKI therapy.
* Alectinib
* Oral, BID, participants will receive the RP2D identified during Phase 1.
* Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
Cohort B
Participants with RET-rearranged NSCLC with previous history of RET-TKI therapy.
* Alectinib
* Oral, BID, participants will receive the RP2D identified during Phase 1.
* Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
Cohort C
Participants with RET-rearranged thyroid cancer
* Alectinib
* Oral, BID, participants will receive the RP2D identified during Phase 1.
* Each treatment cycle will be defined as 28 consecutive days.
Alectinib: -- Oral, BID
* Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
* Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days.
|
|---|---|---|---|---|
|
Overall Survival
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: Data not collected. Trial terminated early due to slow accrual.
Response evaluated using RECIST 1.1 Criteria. Results are incomplete because study closed to accrual early.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data not collected. Trial terminated early due to slow accrual.
Cmax pharmacokinetic parameters will be estimated using non-compartmental models. Comparisons across dose levels will be made to assess proportionality. Results are incomplete because study closed to accrual early.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1 RP2D of Alectinib
Serious events: 0 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 2 Cohort A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Cohort B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2 Cohort C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1 RP2D of Alectinib
n=5 participants at risk
The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have NSCLC, not everyone who participates in this research study will receive the same dose of the study drug. The dosage will depend on the number of participants who have been enrolled in the study and how well the dosage has been tolerated. A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
The AE data presented here includes all 5 participants which were enrolled to the Phase 1 portion of the study, to Dose Level 1.
|
Phase 2 Cohort A
Participants with RET-positive NSCLC with no previous history of RET-TKI therapy. No participants were enrolled to Cohort A.
|
Phase 2 Cohort B
Participants with RET-positive NSCLC with previous history of RET-TKI therapy. No participants were enrolled to Cohort B.
|
Phase 2 Cohort C
Participants with RET-positive thyroid cancer. No participants were enrolled to Cohort C.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 7 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Cardiac disorders
Chest pain - cardiac
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Cardiac disorders
Sinus bradycardia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Gastrointestinal disorders
Stomach pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Number of events 3 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 3 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
General disorders
Pain
|
40.0%
2/5 • Number of events 3 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Investigations
Alkaline phosphatase increased
|
40.0%
2/5 • Number of events 3 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • Number of events 3 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Investigations
CPK increased
|
20.0%
1/5 • Number of events 4 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Investigations
Weight loss
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
2/5 • Number of events 4 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Number of events 3 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
60.0%
3/5 • Number of events 4 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
20.0%
1/5 • Number of events 3 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Nervous system disorders
Concentration impairment
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Nervous system disorders
Lethargy
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Nervous system disorders
Memory impairment
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Psychiatric disorders
Confusion
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Psychiatric disorders
Delirium
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Renal and urinary disorders
Hematuria
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
3/5 • Number of events 3 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
—
0/0 • Adverse events were collected for all participants from first dose through the follow-up period. AE data was collected for approximately 22 months on this study.
AE data is available for the 5 patients enrolled to the Phase I portion of the study. Since the study closed early, no participants were enrolled to Phase 2 Cohorts A, B, or C, and AE and mortality data are not available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place