Trial Outcomes & Findings for Temsirolimus and Pemetrexed for Recurrent or Refractory Non-Small Cell Lung Cancer (NCT NCT00921310)
NCT ID: NCT00921310
Last Updated: 2016-12-13
Results Overview
The starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.
TERMINATED
PHASE1/PHASE2
12 participants
Completion of first cycle by all enrolled patients in Phase I portion of study
2016-12-13
Participant Flow
The study opened to participant enrollment on 09/28/2009 and closed to participant enrollment on 12/20/2011.
Participant milestones
| Measure |
Phase I Dose Level 1 (Pemetrexed & Temsirolimus)
* Pemetrexed 500mg/m\^2 intravenous (IV) on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase I Dose Level -1 (Pemetrexed & Temsirolimus)
* Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
* Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
* Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
6
|
4
|
|
Overall Study
COMPLETED
|
2
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Temsirolimus and Pemetrexed for Recurrent or Refractory Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase I (Premetrexed & Temsirolimus)
n=8 Participants
* Participants enrolled in the Phase I portion Dose Level 1 received:
* Pemetrexed 500mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
* Participants enrolled in the Phase I portion Dose Level -1 received:
* Pemetrexed 375mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
n=4 Participants
-Participants enrolled in the Phase 2 portion received:
* Pemetrexed (375 mg/m2\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
n=5 Participants
|
67.5 years
n=7 Participants
|
62.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Completion of first cycle by all enrolled patients in Phase I portion of studyThe starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.
Outcome measures
| Measure |
Phase I (Premetrexed & Temsirolimus)
n=8 Participants
* Participants enrolled in the Phase I portion Dose Level 1 received:
* Pemetrexed 500mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
* Participants enrolled in the Phase I portion Dose Level -1 received:
* Pemetrexed 375mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
-Participants enrolled in the Phase 2 portion received:
* Pemetrexed (375 mg/m2\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
* Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
* Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
|---|---|---|---|
|
Phase I Only: Maximum Tolerated Dose (MTD) of Pemetrexed That Could be Administered Weekly in Combination With Temsirolimus
|
375 mg/m^2
|
—
|
—
|
PRIMARY outcome
Timeframe: Completion of first cycle by all enrolled patients in Phase I portion of studyThe starting dose and schedule of pemetrexed will be 500 mg/m2 given every 3 weeks and the starting dose for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level. The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort experience dose-limiting toxicity during the first cycle. Six patients will be enrolled at the maximum tolerated dose to ensure that no more than 2 DLTs occur at the MTD. Dose escalations will proceed until the MTD has been reached.
Outcome measures
| Measure |
Phase I (Premetrexed & Temsirolimus)
n=8 Participants
* Participants enrolled in the Phase I portion Dose Level 1 received:
* Pemetrexed 500mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
* Participants enrolled in the Phase I portion Dose Level -1 received:
* Pemetrexed 375mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
-Participants enrolled in the Phase 2 portion received:
* Pemetrexed (375 mg/m2\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
* Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
* Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
|---|---|---|---|
|
Phase I Only: Maximum Tolerated Dose (MTD) of Temsirolimus That Could be Administered Weekly in Combination With Pemetrexed
|
15 mg
|
—
|
—
|
PRIMARY outcome
Timeframe: Completion of first cycle (approximately 21 days)DLT will be defined as occurring within the first cycle of Phase I only and will be graded according to the Common Terminology Criteria for Adverse Events v 3.0 (CTCAE) * Any grade 3 or higher hematologic toxicity with the exception of anemia. * Any grade 3 or higher non-hematologic toxicity related to study therapy (except alopecia). * Grade 3 or 4 pneumonitis or esophagitis. * Treatment delay of temsirolimus for more than 14 consecutive days due to study-related toxicity. * Treatment delay of pemetrexed therapy for more than 14 consecutive days because of study-related toxicity.
Outcome measures
| Measure |
Phase I (Premetrexed & Temsirolimus)
n=2 Participants
* Participants enrolled in the Phase I portion Dose Level 1 received:
* Pemetrexed 500mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
* Participants enrolled in the Phase I portion Dose Level -1 received:
* Pemetrexed 375mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
n=6 Participants
-Participants enrolled in the Phase 2 portion received:
* Pemetrexed (375 mg/m2\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
* Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
* Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
|---|---|---|---|
|
Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLT) of Temsirolimus and Pemetrexed
|
2 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: (4) patients in Phase 1 were not evaluable for response as they were removed from study prior to week 6 scans. One patient in Phase 2 was not evaluable due to expiring prior to week 6 scans.
* Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. * Complete response (CR)-disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. * Partial response (PR)-at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD
Outcome measures
| Measure |
Phase I (Premetrexed & Temsirolimus)
n=4 Participants
* Participants enrolled in the Phase I portion Dose Level 1 received:
* Pemetrexed 500mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
* Participants enrolled in the Phase I portion Dose Level -1 received:
* Pemetrexed 375mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
n=3 Participants
-Participants enrolled in the Phase 2 portion received:
* Pemetrexed (375 mg/m2\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
* Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
* Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
|---|---|---|---|
|
Phase I and Phase II: Overall Response Rate (Complete Response + Partial Response)
|
0 percentage of participants
|
33.3 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8Population: Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8Population: Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 years from completion of treatmentPopulation: There were only (2) patients evaluable for PFS.
PFS is defined as the duration of time from start of treatment to time of progression.
Outcome measures
| Measure |
Phase I (Premetrexed & Temsirolimus)
* Participants enrolled in the Phase I portion Dose Level 1 received:
* Pemetrexed 500mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
* Participants enrolled in the Phase I portion Dose Level -1 received:
* Pemetrexed 375mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
n=2 Participants
-Participants enrolled in the Phase 2 portion received:
* Pemetrexed (375 mg/m2\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
* Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
* Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
|---|---|---|---|
|
Phase 2 Only: Progression-free Survival (PFS)
Patient A
|
—
|
523 days
|
—
|
|
Phase 2 Only: Progression-free Survival (PFS)
Patient B
|
—
|
167 days
|
—
|
SECONDARY outcome
Timeframe: 1 year after start of treatmentOutcome measures
| Measure |
Phase I (Premetrexed & Temsirolimus)
* Participants enrolled in the Phase I portion Dose Level 1 received:
* Pemetrexed 500mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
* Participants enrolled in the Phase I portion Dose Level -1 received:
* Pemetrexed 375mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
n=4 Participants
-Participants enrolled in the Phase 2 portion received:
* Pemetrexed (375 mg/m2\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
* Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
* Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
|---|---|---|---|
|
Phase 2 Only: Survival Rate
|
—
|
50 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8Population: Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 Day 1, one hour post completion of initial temsirolimus dose, and Cycle 1 Day 8Population: Due to early termination of the study by withdrawal of funding by sponsor (Pfizer merged with Wyeth), the peripheral blood samples that were collected for this outcome measure were not analyzed prior to losing funding.
Outcome measures
Outcome data not reported
Adverse Events
Phase I (Premetrexed & Temsirolimus)
Phase 2 (Pemetrexed & Temsirolimus)
Serious adverse events
| Measure |
Phase I (Premetrexed & Temsirolimus)
n=8 participants at risk
* Dose Level 1
* Pemetrexed 500mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
* Dose Level -1
* Pemetrexed 375mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
n=4 participants at risk
Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
|---|---|---|
|
Investigations
Neutrophils (ANC)
|
12.5%
1/8
|
0.00%
0/4
|
|
Investigations
Leukocytes (WBC)
|
25.0%
2/8
|
0.00%
0/4
|
|
Investigations
Platelets
|
12.5%
1/8
|
0.00%
0/4
|
|
Cardiac disorders
Chest pain
|
12.5%
1/8
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8
|
0.00%
0/4
|
|
Vascular disorders
Pulmonary embolism
|
25.0%
2/8
|
25.0%
1/4
|
|
General disorders
Disease progression - death
|
12.5%
1/8
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8
|
25.0%
1/4
|
|
Infections and infestations
Infection - pneumonia
|
0.00%
0/8
|
25.0%
1/4
|
|
Infections and infestations
Septic shock
|
0.00%
0/8
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonitis
|
0.00%
0/8
|
25.0%
1/4
|
Other adverse events
| Measure |
Phase I (Premetrexed & Temsirolimus)
n=8 participants at risk
* Dose Level 1
* Pemetrexed 500mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
* Dose Level -1
* Pemetrexed 375mg/m\^2 IV on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle
|
Phase 2 (Pemetrexed & Temsirolimus)
n=4 participants at risk
Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
|
|---|---|---|
|
Investigations
ALT
|
37.5%
3/8
|
50.0%
2/4
|
|
Investigations
AST
|
62.5%
5/8
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Albumin - low
|
37.5%
3/8
|
100.0%
4/4
|
|
Investigations
Alkaline phosphatase
|
37.5%
3/8
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
4/8
|
50.0%
2/4
|
|
Investigations
Bilirubin
|
12.5%
1/8
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
12.5%
1/8
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Calcium - low
|
37.5%
3/8
|
25.0%
1/4
|
|
Cardiac disorders
Chest pain
|
12.5%
1/8
|
0.00%
0/4
|
|
Investigations
Chloesterol - high
|
0.00%
0/8
|
50.0%
2/4
|
|
Nervous system disorders
Confusion
|
12.5%
1/8
|
0.00%
0/4
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
50.0%
2/4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
|
25.0%
1/4
|
|
Investigations
Creatinine
|
25.0%
2/8
|
25.0%
1/4
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8
|
25.0%
1/4
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
50.0%
2/4
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/8
|
25.0%
1/4
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8
|
25.0%
1/4
|
|
General disorders
Edema
|
25.0%
2/8
|
75.0%
3/4
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8
|
25.0%
1/4
|
|
General disorders
Fatigue
|
37.5%
3/8
|
75.0%
3/4
|
|
General disorders
Fever
|
0.00%
0/8
|
50.0%
2/4
|
|
Metabolism and nutrition disorders
Glucose - high
|
62.5%
5/8
|
50.0%
2/4
|
|
Investigations
Hand pain
|
12.5%
1/8
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
25.0%
2/8
|
25.0%
1/4
|
|
Blood and lymphatic system disorders
Hemoglobin
|
87.5%
7/8
|
100.0%
4/4
|
|
Vascular disorders
Hot flashes
|
12.5%
1/8
|
0.00%
0/4
|
|
Vascular disorders
Hypotension
|
12.5%
1/8
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8
|
0.00%
0/4
|
|
Investigations
INR
|
12.5%
1/8
|
0.00%
0/4
|
|
General disorders
Infusion reaction
|
0.00%
0/8
|
25.0%
1/4
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8
|
75.0%
3/4
|
|
Investigations
Leukocytes (WBC)
|
75.0%
6/8
|
75.0%
3/4
|
|
Investigations
Lymphopenia
|
100.0%
8/8
|
100.0%
4/4
|
|
Metabolism and nutrition disorders
Magnesium - low
|
12.5%
1/8
|
0.00%
0/4
|
|
Psychiatric disorders
Mood alteration - anxiety
|
0.00%
0/8
|
25.0%
1/4
|
|
Psychiatric disorders
Mood alteration - depression
|
12.5%
1/8
|
50.0%
2/4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8
|
25.0%
1/4
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8
|
75.0%
3/4
|
|
Investigations
Neutrophils (ANC)
|
37.5%
3/8
|
75.0%
3/4
|
|
General disorders
Pain NOS
|
12.5%
1/8
|
0.00%
0/4
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8
|
25.0%
1/4
|
|
Metabolism and nutrition disorders
Phosphorus - low
|
25.0%
2/8
|
25.0%
1/4
|
|
Investigations
Platelets
|
62.5%
5/8
|
100.0%
4/4
|
|
Metabolism and nutrition disorders
Potassium - high
|
25.0%
2/8
|
25.0%
1/4
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8
|
50.0%
2/4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8
|
0.00%
0/4
|
|
Nervous system disorders
Sensory neuropathy
|
0.00%
0/8
|
25.0%
1/4
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitous ulcer
|
12.5%
1/8
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Sodium - low
|
25.0%
2/8
|
25.0%
1/4
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8
|
50.0%
2/4
|
|
General disorders
Sweating
|
0.00%
0/8
|
25.0%
1/4
|
|
Investigations
Throat pain
|
12.5%
1/8
|
0.00%
0/4
|
|
Investigations
Triglycerides - high
|
12.5%
1/8
|
25.0%
1/4
|
|
Infections and infestations
Upper respiratory infection
|
37.5%
3/8
|
0.00%
0/4
|
|
Infections and infestations
Viral flare (herpes)
|
0.00%
0/8
|
25.0%
1/4
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8
|
25.0%
1/4
|
|
Eye disorders
Watery eyes
|
12.5%
1/8
|
25.0%
1/4
|
|
Investigations
Weight loss
|
25.0%
2/8
|
25.0%
1/4
|
Additional Information
Maria Baggstrom, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place