Trial Outcomes & Findings for Lestaurtinib, Cytarabine, and Idarubicin in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT00469859)
NCT ID: NCT00469859
Last Updated: 2017-03-15
Results Overview
Number of patients with dose-limiting toxicity (DLT)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
28 days
Results posted on
2017-03-15
Participant Flow
Participant milestones
| Measure |
Group 1 (Lestaurtinib Dose 50 mg/m2)
COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
Group 2 (Lestaurtinib: Dose 62.5 mg/m2)
COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
cytarabine
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Group 1 (Lestaurtinib Dose 50 mg/m2)
COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
Group 2 (Lestaurtinib: Dose 62.5 mg/m2)
COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
cytarabine
|
|---|---|---|
|
Overall Study
Inevaluable
|
0
|
2
|
Baseline Characteristics
Lestaurtinib, Cytarabine, and Idarubicin in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Group 1 (Lestaurtinib Dose 50 mg/m2
n=6 Participants
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
Group 2 (Lestaurtinib: Dose 62.5 mg/m2
n=8 Participants
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysNumber of patients with dose-limiting toxicity (DLT)
Outcome measures
| Measure |
Group 1 (Lestaurtinib Dose 50 mg/m2
n=6 Participants
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
Group 2 (Lestaurtinib: Dose 62.5 mg/m2
n=6 Participants
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
|---|---|---|
|
Dose-limiting Toxicity
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Course 1 day 7, day 14, day 21, and day 28.FLT3 inhibition is determined in patients receiving lestaurtinib by measuring FLT3 plasma inhibitory activity (PIA). For PIA predictive modeling, a random effects linear regression model will be used to describe the relationship between PIA and Pharmacokinetic (PK) levels for each of the 5 trough plasma samples collected for each patient
Outcome measures
| Measure |
Group 1 (Lestaurtinib Dose 50 mg/m2
n=6 Participants
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
Group 2 (Lestaurtinib: Dose 62.5 mg/m2
n=6 Participants
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
|---|---|---|
|
>80% Inhibition of FLT3 Phosphorylation in a Majority of Post-treatment Trough Time Points
|
5 participants
|
5 participants
|
Adverse Events
Group 1 (Lestaurtinib Dose 50 mg/m2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2 (Lestaurtinib: Dose 62.5 mg/m2
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (Lestaurtinib Dose 50 mg/m2
n=6 participants at risk
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
Group 2 (Lestaurtinib: Dose 62.5 mg/m2
n=8 participants at risk
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
25.0%
2/8
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Activated partial thromboplastin time prolonged
|
16.7%
1/6
|
0.00%
0/8
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/6
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6
|
37.5%
3/8
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6
|
12.5%
1/8
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6
|
12.5%
1/8
|
|
Cardiac disorders
Cardiac disorders - Other
|
0.00%
0/6
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/6
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6
|
50.0%
4/8
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6
|
37.5%
3/8
|
|
Infections and infestations
Infections and infestations - Other
|
16.7%
1/6
|
50.0%
4/8
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6
|
12.5%
1/8
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6
|
0.00%
0/8
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6
|
12.5%
1/8
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Platelet count decreased
|
0.00%
0/6
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6
|
12.5%
1/8
|
|
Nervous system disorders
Seizure
|
0.00%
0/6
|
12.5%
1/8
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Weight gain
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
White blood cell decreased
|
0.00%
0/6
|
25.0%
2/8
|
Other adverse events
| Measure |
Group 1 (Lestaurtinib Dose 50 mg/m2
n=6 participants at risk
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
Group 2 (Lestaurtinib: Dose 62.5 mg/m2
n=8 participants at risk
COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.
COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.
CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Continued (see detailed description)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6
|
75.0%
6/8
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6
|
12.5%
1/8
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6
|
0.00%
0/8
|
|
Psychiatric disorders
Depression
|
16.7%
1/6
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/6
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6
|
37.5%
3/8
|
|
General disorders
Fever
|
0.00%
0/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6
|
0.00%
0/8
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6
|
25.0%
2/8
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6
|
25.0%
2/8
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6
|
0.00%
0/8
|
|
Vascular disorders
Hypotension
|
16.7%
1/6
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6
|
25.0%
2/8
|
|
Infections and infestations
Infections and infestations - Other
|
16.7%
1/6
|
25.0%
2/8
|
|
Investigations
Lipase increased
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6
|
62.5%
5/8
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6
|
12.5%
1/8
|
|
Investigations
Neutrophil count decreased
|
66.7%
4/6
|
62.5%
5/8
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Platelet count decreased
|
66.7%
4/6
|
75.0%
6/8
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Rectal pain
|
16.7%
1/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/6
|
12.5%
1/8
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
16.7%
1/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Weight loss
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
White blood cell decreased
|
66.7%
4/6
|
37.5%
3/8
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER