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Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00305864
Recruitment Status : Completed
First Posted : March 22, 2006
Results First Posted : May 17, 2013
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Interventions Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Motexafin Gadolinium
Drug: Temozolomide
Enrollment 118
Recruitment Details  
Pre-assignment Details In multicenter clinical trials the accrual closure date must be predicted so that sites can be notified weeks in advance. As expected, this process often results in a final number of patients differing from the planned accrual.
Arm/Group Title Phase I: MGd 3 mg/kg Phase I: MGd 4 mg/kg Phase I: MGd 5 mg/kg Phase II: MGd 5 mg/kg
Hide Arm/Group Description Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 7 10 7 94
Completed 7 9 6 81
Not Completed 0 1 1 13
Reason Not Completed
Ineligible / No protocol treatment             0             1             1             13
Arm/Group Title Phase I: MGd 3 mg/kg Phase I: MGd 4 mg/kg Phase I: MGd 5 mg/kg Phase II: MGd 5 mg/kg Total
Hide Arm/Group Description Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 7 10 7 94 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 10 participants 7 participants 94 participants 118 participants
56
(44 to 67)
57.5
(37 to 72)
58
(40 to 65)
57.5
(20 to 81)
57
(20 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 7 participants 94 participants 118 participants
Female
4
  57.1%
6
  60.0%
1
  14.3%
33
  35.1%
44
  37.3%
Male
3
  42.9%
4
  40.0%
6
  85.7%
61
  64.9%
74
  62.7%
1.Primary Outcome
Title Maximum Tolerated Dose of MGd (Phase I)
Hide Description

Patients were to be followed for a minimum of 90 days from the start of radiation therapy (RT) and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as a grade 4 neurologic adverse event (AE) considered to be related to treatment occurring within 21 days of the conclusion of RT. For each dose level, up to seven patients were to be accrued to assure that there would be six eligible for treatment adverse event evaluation. A dose level of MGd was considered acceptable if no more than 1 patient of the 6 experience a DLT. If the current level was considered acceptable, then dose escalation occurred. Otherwise, the preceding dose level would be declared the maximum tolerated dose (MTD). The MTD would be used for the Phase II arm.

Rating scale: 0 = not the MTD, 1 = MTD

Time Frame From start of radiation therapy to 90 days,
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received protocol treatment.
Arm/Group Title Phase I: MGd 3 mg/kg Phase I: MGd 4 mg/kg Phase I: 5 mg/kg
Hide Arm/Group Description:
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 7 9 6
Measure Type: Number
Unit of Measure: units on a scale
0 0 1
2.Primary Outcome
Title Median Overall Survival (Phase II)
Hide Description Survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.
Time Frame From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients.
Arm/Group Title All MGd 5mg/kg Patients (Phase I and II Arms Combined)
Hide Arm/Group Description:
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 87
Median (95% Confidence Interval)
Unit of Measure: Months
15.6
(12.9 to 17.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All MGd 5mg/kg Patients (Phase I and II Arms Combined)
Comments A one-sided one-sample log-rank test at significance level of 0.10 was predicted to have 85% power to detect a survival difference against the historical control (13.7 vs. 18.5 months) with 60 deaths.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Log Rank
Comments One-sided
3.Secondary Outcome
Title Progression-free Survival (Phase II)
Hide Description Progression will be defined as a > 25% increase in tumor area. Progression-free survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.
Time Frame From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients
Arm/Group Title All MGd 5mg/kg Patients (Phase I and II Arms Combined)
Hide Arm/Group Description:
Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 87
Median (95% Confidence Interval)
Unit of Measure: months
7.6
(5.7 to 9.6)
Time Frame [Not Specified]
Adverse Event Reporting Description Per the protocol, toxicity data was collected via Common Toxicity Criteria (CTC) 3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" adverse event (AE) are counted only once for that "Other (Not Including Serious)" AE.
 
Arm/Group Title Phase I: MGd 3 mg/kg Phase I: MGd 4 mg/kg Phase I: MGd 5 mg/kg Phase II: MGd 5 mg/kg
Hide Arm/Group Description Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Phase I: MGd 3 mg/kg Phase I: MGd 4 mg/kg Phase I: MGd 5 mg/kg Phase II: MGd 5 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Phase I: MGd 3 mg/kg Phase I: MGd 4 mg/kg Phase I: MGd 5 mg/kg Phase II: MGd 5 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/7 (42.86%)   6/9 (66.67%)   4/6 (66.67%)   48/81 (59.26%) 
Blood and lymphatic system disorders         
Anemia * 1  1/7 (14.29%)  2/9 (22.22%)  0/6 (0.00%)  3/81 (3.70%) 
Blood and lymphatic system disorders - Other * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  1/81 (1.23%) 
Febrile neutropenia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Cardiac disorders         
Cardiac disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Sinus tachycardia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Gastrointestinal disorders         
Abdominal pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Colitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Diarrhea * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Dysphagia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Enterocolitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Esophagitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Mucositis oral * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Nausea * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Pancreatitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Vomiting * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
General disorders         
Chills * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Death NOS * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Edema limbs * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Facial pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Fatigue * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  11/81 (13.58%) 
Fever * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  12/81 (14.81%) 
Non-cardiac chest pain * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/81 (0.00%) 
Sudden death NOS * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Immune system disorders         
Allergic reaction * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  4/81 (4.94%) 
Infections and infestations         
Bronchial infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Infections and infestations - Other * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  4/81 (4.94%) 
Lung infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Phlebitis infective * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Urinary tract infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Wound infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Injury, poisoning and procedural complications         
Vascular access complication * 1  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Wound dehiscence * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Investigations         
Alanine aminotransferase increased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  7/81 (8.64%) 
Alkaline phosphatase increased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Aspartate aminotransferase increased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  5/81 (6.17%) 
Blood bilirubin increased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Creatinine increased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Lymphocyte count decreased * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  9/81 (11.11%) 
Neutrophil count decreased * 1  1/7 (14.29%)  3/9 (33.33%)  0/6 (0.00%)  6/81 (7.41%) 
Platelet count decreased * 1  1/7 (14.29%)  2/9 (22.22%)  0/6 (0.00%)  7/81 (8.64%) 
White blood cell decreased * 1  1/7 (14.29%)  2/9 (22.22%)  0/6 (0.00%)  10/81 (12.35%) 
Metabolism and nutrition disorders         
Anorexia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Dehydration * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  5/81 (6.17%) 
Hyperglycemia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Hypoalbuminemia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Hypocalcemia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Hypokalemia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Hypomagnesemia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Hyponatremia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Hypophosphatemia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  18/81 (22.22%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Generalized muscle weakness * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Pain in extremity * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Nervous system disorders         
Central nervous system necrosis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Cerebrospinal fluid leakage * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Cognitive disturbance * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Depressed level of consciousness * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Dizziness * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Dysphasia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Headache * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Hydrocephalus * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Intracranial hemorrhage * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Ischemia cerebrovascular * 1  2/7 (28.57%)  0/9 (0.00%)  0/6 (0.00%)  0/81 (0.00%) 
Memory impairment * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Nervous system disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Peripheral motor neuropathy * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Peripheral sensory neuropathy * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Pyramidal tract syndrome * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Recurrent laryngeal nerve palsy * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/81 (0.00%) 
Seizure * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Syncope * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Psychiatric disorders         
Agitation * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Confusion * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  4/81 (4.94%) 
Psychosis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Renal and urinary disorders         
Acute kidney injury * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnea * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Hypoxia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Pneumonitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Hyperhidrosis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Palmar-plantar erythrodysesthesia syndrome * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Pruritus * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Rash maculo-papular * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Skin and subcutaneous tissue disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Vascular disorders         
Thromboembolic event * 1  0/7 (0.00%)  2/9 (22.22%)  1/6 (16.67%)  4/81 (4.94%) 
Vascular disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I: MGd 3 mg/kg Phase I: MGd 4 mg/kg Phase I: MGd 5 mg/kg Phase II: MGd 5 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   9/9 (100.00%)   6/6 (100.00%)   80/81 (98.77%) 
Blood and lymphatic system disorders         
Anemia * 1  4/7 (57.14%)  2/9 (22.22%)  2/6 (33.33%)  41/81 (50.62%) 
Blood and lymphatic system disorders - Other * 1  1/7 (14.29%)  2/9 (22.22%)  0/6 (0.00%)  0/81 (0.00%) 
Cardiac disorders         
Cardiac disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Chest pain - cardiac * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Palpitations * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Sinus tachycardia * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Ear and labyrinth disorders         
Ear pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
External ear inflammation * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Hearing impaired * 1  1/7 (14.29%)  0/9 (0.00%)  2/6 (33.33%)  5/81 (6.17%) 
Middle ear inflammation * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  1/81 (1.23%) 
Tinnitus * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  6/81 (7.41%) 
Endocrine disorders         
Cushingoid * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  2/81 (2.47%) 
Endocrine disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Eye disorders         
Blurred vision * 1  1/7 (14.29%)  1/9 (11.11%)  2/6 (33.33%)  13/81 (16.05%) 
Conjunctivitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Dry eye * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Extraocular muscle paresis * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  4/81 (4.94%) 
Eye disorders - Other * 1  4/7 (57.14%)  0/9 (0.00%)  1/6 (16.67%)  20/81 (24.69%) 
Eye pain * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  2/81 (2.47%) 
Flashing lights * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  1/81 (1.23%) 
Optic nerve disorder * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Photophobia * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  2/81 (2.47%) 
Uveitis * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/81 (0.00%) 
Watering eyes * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Gastrointestinal disorders         
Abdominal distension * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Abdominal pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Anal pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Constipation * 1  3/7 (42.86%)  3/9 (33.33%)  2/6 (33.33%)  39/81 (48.15%) 
Dental caries * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Diarrhea * 1  4/7 (57.14%)  2/9 (22.22%)  1/6 (16.67%)  20/81 (24.69%) 
Dry mouth * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  4/81 (4.94%) 
Dyspepsia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  7/81 (8.64%) 
Dysphagia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Fecal incontinence * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Flatulence * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Gastric stenosis * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Gastritis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Gastrointestinal disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Hemorrhoids * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Mucositis oral * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  4/81 (4.94%) 
Nausea * 1  4/7 (57.14%)  2/9 (22.22%)  3/6 (50.00%)  55/81 (67.90%) 
Oral pain * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  2/81 (2.47%) 
Pancreatitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Rectal hemorrhage * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Stomach pain * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  1/81 (1.23%) 
Toothache * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Vomiting * 1  3/7 (42.86%)  2/9 (22.22%)  0/6 (0.00%)  28/81 (34.57%) 
General disorders         
Chills * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  15/81 (18.52%) 
Death NOS * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Edema face * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Edema limbs * 1  3/7 (42.86%)  1/9 (11.11%)  0/6 (0.00%)  16/81 (19.75%) 
Edema trunk * 1  1/7 (14.29%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Facial pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Fatigue * 1  6/7 (85.71%)  7/9 (77.78%)  5/6 (83.33%)  70/81 (86.42%) 
Fever * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  15/81 (18.52%) 
Flu like symptoms * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Gait disturbance * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  5/81 (6.17%) 
General disorders and administration site conditions - Other * 1  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Injection site reaction * 1  0/7 (0.00%)  3/9 (33.33%)  1/6 (16.67%)  2/81 (2.47%) 
Non-cardiac chest pain * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  1/81 (1.23%) 
Pain * 1  0/7 (0.00%)  0/9 (0.00%)  2/6 (33.33%)  8/81 (9.88%) 
Hepatobiliary disorders         
Hepatobiliary disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Immune system disorders         
Allergic reaction * 1  1/7 (14.29%)  0/9 (0.00%)  3/6 (50.00%)  11/81 (13.58%) 
Infections and infestations         
Bladder infection * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  1/81 (1.23%) 
Bronchial infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Catheter related infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Eye infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Gum infection * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  3/81 (3.70%) 
Infections and infestations - Other * 1  1/7 (14.29%)  1/9 (11.11%)  0/6 (0.00%)  9/81 (11.11%) 
Lip infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Mucosal infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Sinusitis * 1  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/81 (0.00%) 
Skin infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Soft tissue infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Tracheitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Upper respiratory infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Urinary tract infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Vulval infection * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Wound infection * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Injury, poisoning and procedural complications         
Bruising * 1  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  6/81 (7.41%) 
Burn * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Dermatitis radiation * 1  1/7 (14.29%)  3/9 (33.33%)  2/6 (33.33%)  16/81 (19.75%) 
Radiation recall reaction (dermatologic) * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Vascular access complication * 1  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  0/81 (0.00%) 
Wound dehiscence * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Investigations         
Activated partial thromboplastin time prolonged * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Alanine aminotransferase increased * 1  5/7 (71.43%)  4/9 (44.44%)  4/6 (66.67%)  49/81 (60.49%) 
Alkaline phosphatase increased * 1  1/7 (14.29%)  3/9 (33.33%)  0/6 (0.00%)  19/81 (23.46%) 
Aspartate aminotransferase increased * 1  4/7 (57.14%)  3/9 (33.33%)  2/6 (33.33%)  34/81 (41.98%) 
Blood bilirubin increased * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  8/81 (9.88%) 
Cholesterol high * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Creatinine increased * 1  1/7 (14.29%)  1/9 (11.11%)  0/6 (0.00%)  10/81 (12.35%) 
GGT increased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Haptoglobin decreased * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
INR increased * 1  1/7 (14.29%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Investigations - Other * 1  3/7 (42.86%)  1/9 (11.11%)  1/6 (16.67%)  11/81 (13.58%) 
Lipase increased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Lymphocyte count decreased * 1  0/7 (0.00%)  3/9 (33.33%)  1/6 (16.67%)  47/81 (58.02%) 
Neutrophil count decreased * 1  1/7 (14.29%)  1/9 (11.11%)  1/6 (16.67%)  14/81 (17.28%) 
Platelet count decreased * 1  2/7 (28.57%)  3/9 (33.33%)  2/6 (33.33%)  37/81 (45.68%) 
Serum amylase increased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Weight gain * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  4/81 (4.94%) 
Weight loss * 1  2/7 (28.57%)  1/9 (11.11%)  1/6 (16.67%)  19/81 (23.46%) 
White blood cell decreased * 1  1/7 (14.29%)  1/9 (11.11%)  0/6 (0.00%)  32/81 (39.51%) 
Metabolism and nutrition disorders         
Acidosis * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Anorexia * 1  4/7 (57.14%)  3/9 (33.33%)  4/6 (66.67%)  37/81 (45.68%) 
Dehydration * 1  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  4/81 (4.94%) 
Hyperglycemia * 1  5/7 (71.43%)  3/9 (33.33%)  0/6 (0.00%)  36/81 (44.44%) 
Hyperkalemia * 1  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Hypernatremia * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  3/81 (3.70%) 
Hypertriglyceridemia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Hyperuricemia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Hypoalbuminemia * 1  3/7 (42.86%)  2/9 (22.22%)  1/6 (16.67%)  11/81 (13.58%) 
Hypocalcemia * 1  1/7 (14.29%)  2/9 (22.22%)  0/6 (0.00%)  19/81 (23.46%) 
Hypoglycemia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Hypokalemia * 1  2/7 (28.57%)  1/9 (11.11%)  0/6 (0.00%)  29/81 (35.80%) 
Hypomagnesemia * 1  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  5/81 (6.17%) 
Hyponatremia * 1  1/7 (14.29%)  1/9 (11.11%)  2/6 (33.33%)  15/81 (18.52%) 
Hypophosphatemia * 1  5/7 (71.43%)  7/9 (77.78%)  3/6 (50.00%)  56/81 (69.14%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  24/81 (29.63%) 
Arthritis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Avascular necrosis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Back pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  5/81 (6.17%) 
Bone pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Generalized muscle weakness * 1  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  10/81 (12.35%) 
Joint range of motion decreased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Muscle weakness left-sided * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  2/81 (2.47%) 
Muscle weakness lower limb * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  12/81 (14.81%) 
Muscle weakness right-sided * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Muscle weakness upper limb * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Musculoskeletal and connective tissue disorder - Other * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  2/81 (2.47%) 
Myalgia * 1  1/7 (14.29%)  0/9 (0.00%)  1/6 (16.67%)  10/81 (12.35%) 
Neck pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Pain in extremity * 1  0/7 (0.00%)  2/9 (22.22%)  0/6 (0.00%)  7/81 (8.64%) 
Nervous system disorders         
Acoustic nerve disorder NOS * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  3/81 (3.70%) 
Ataxia * 1  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  5/81 (6.17%) 
Central nervous system necrosis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Cognitive disturbance * 1  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  5/81 (6.17%) 
Depressed level of consciousness * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  6/81 (7.41%) 
Dizziness * 1  0/7 (0.00%)  2/9 (22.22%)  1/6 (16.67%)  12/81 (14.81%) 
Dysgeusia * 1  4/7 (57.14%)  2/9 (22.22%)  3/6 (50.00%)  19/81 (23.46%) 
Dysphasia * 1  1/7 (14.29%)  2/9 (22.22%)  2/6 (33.33%)  8/81 (9.88%) 
Extrapyramidal disorder * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  2/81 (2.47%) 
Facial nerve disorder * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Headache * 1  4/7 (57.14%)  2/9 (22.22%)  2/6 (33.33%)  45/81 (55.56%) 
Hydrocephalus * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Leukoencephalopathy * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/81 (0.00%) 
Memory impairment * 1  1/7 (14.29%)  1/9 (11.11%)  1/6 (16.67%)  21/81 (25.93%) 
Nervous system disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  6/81 (7.41%) 
Neuralgia * 1  2/7 (28.57%)  2/9 (22.22%)  1/6 (16.67%)  5/81 (6.17%) 
Oculomotor nerve disorder * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Peripheral motor neuropathy * 1  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  18/81 (22.22%) 
Peripheral sensory neuropathy * 1  3/7 (42.86%)  2/9 (22.22%)  2/6 (33.33%)  27/81 (33.33%) 
Seizure * 1  1/7 (14.29%)  3/9 (33.33%)  2/6 (33.33%)  11/81 (13.58%) 
Sinus pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Syncope * 1  1/7 (14.29%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Tremor * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  8/81 (9.88%) 
Psychiatric disorders         
Agitation * 1  0/7 (0.00%)  1/9 (11.11%)  2/6 (33.33%)  6/81 (7.41%) 
Anxiety * 1  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  15/81 (18.52%) 
Confusion * 1  0/7 (0.00%)  1/9 (11.11%)  3/6 (50.00%)  22/81 (27.16%) 
Depression * 1  1/7 (14.29%)  1/9 (11.11%)  1/6 (16.67%)  14/81 (17.28%) 
Insomnia * 1  1/7 (14.29%)  2/9 (22.22%)  1/6 (16.67%)  21/81 (25.93%) 
Libido decreased * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Personality change * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/81 (3.70%) 
Renal and urinary disorders         
Chronic kidney disease * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/81 (0.00%) 
Urinary frequency * 1  1/7 (14.29%)  1/9 (11.11%)  1/6 (16.67%)  15/81 (18.52%) 
Urinary incontinence * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  3/81 (3.70%) 
Urinary tract obstruction * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Urinary tract pain * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Urine discoloration * 1  5/7 (71.43%)  3/9 (33.33%)  2/6 (33.33%)  25/81 (30.86%) 
Respiratory, thoracic and mediastinal disorders         
Allergic rhinitis * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  2/81 (2.47%) 
Apnea * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Bronchospasm * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Cough * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  12/81 (14.81%) 
Dyspnea * 1  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  16/81 (19.75%) 
Epistaxis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Pneumonitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Respiratory, thoracic and mediastinal disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Sinus disorder * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Voice alteration * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Skin and subcutaneous tissue disorders         
Alopecia * 1  3/7 (42.86%)  5/9 (55.56%)  4/6 (66.67%)  56/81 (69.14%) 
Body odor * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Dry skin * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  10/81 (12.35%) 
Erythema multiforme * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Hyperhidrosis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Nail loss * 1  3/7 (42.86%)  2/9 (22.22%)  2/6 (33.33%)  15/81 (18.52%) 
Pain of skin * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Palmar-plantar erythrodysesthesia syndrome * 1  3/7 (42.86%)  3/9 (33.33%)  3/6 (50.00%)  17/81 (20.99%) 
Photosensitivity * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Pruritus * 1  0/7 (0.00%)  2/9 (22.22%)  1/6 (16.67%)  14/81 (17.28%) 
Purpura * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Rash acneiform * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Rash maculo-papular * 1  1/7 (14.29%)  1/9 (11.11%)  2/6 (33.33%)  13/81 (16.05%) 
Skin and subcutaneous tissue disorders - Other * 1  1/7 (14.29%)  1/9 (11.11%)  2/6 (33.33%)  31/81 (38.27%) 
Skin hyperpigmentation * 1  5/7 (71.43%)  5/9 (55.56%)  2/6 (33.33%)  33/81 (40.74%) 
Skin ulceration * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  4/81 (4.94%) 
Vascular disorders         
Flushing * 1  0/7 (0.00%)  1/9 (11.11%)  2/6 (33.33%)  4/81 (4.94%) 
Hematoma * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Hot flashes * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  2/81 (2.47%) 
Hypertension * 1  1/7 (14.29%)  0/9 (0.00%)  1/6 (16.67%)  13/81 (16.05%) 
Hypotension * 1  0/7 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  3/81 (3.70%) 
Phlebitis * 1  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/81 (1.23%) 
Thromboembolic event * 1  1/7 (14.29%)  3/9 (33.33%)  0/6 (0.00%)  3/81 (3.70%) 
Vascular disorders - Other * 1  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  3/81 (3.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00305864    
Other Study ID Numbers: NCI-2009-01092
NCI-2009-01092 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000467802
RTOG 0513 ( Other Identifier: Radiation Therapy Oncology Group )
RTOG-0513 ( Other Identifier: CTEP )
U10CA021661 ( U.S. NIH Grant/Contract )
First Submitted: March 21, 2006
First Posted: March 22, 2006
Results First Submitted: March 5, 2013
Results First Posted: May 17, 2013
Last Update Posted: March 5, 2018