Trial Outcomes & Findings for Panitumumab, Combination Chemotherapy, & Radiation Therapy in Esophageal or Gastroesophageal Junction Cancer (NCT NCT01307956)

Last Updated: 2023-10-26

Results Overview

Based on the proportion who achieve pCR based on the first 4 courses of protocol treatment. Evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Up to 8 weeks

Results posted on

2023-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Panitumumab, Chemotherapy, Radiation) Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Panitumumab, Combination Chemotherapy, & Radiation Therapy in Esophageal or Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Panitumumab, Chemotherapy, Radiation) n=11 Participants Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	1 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks

Outcome measures

Outcome measures
Measure	Treatment (Panitumumab, Chemotherapy, Radiation) n=11 Participants Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
Complete Pathological Response (pCR) Rate	3 Participants

SECONDARY outcome

Timeframe: 4 weeks after completion of the radiation

Restaging with repeat imaging studies will be performed. If no contraindication for surgical resection is identified, resection will be performed. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate.

Outcome measures

Outcome measures
Measure	Treatment (Panitumumab, Chemotherapy, Radiation) n=11 Participants Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
Number of Patients Who Can Undergo Resection	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Patients were followed from time of consent until the date of first documented progession or date of death from any cause, whichever came first, assessed up to 100 months.

Descriptively summarized using the method of Kaplan-Meier. Response and disease progression were assessed using RECIST criteria version 1.1

Outcome measures

Outcome measures
Measure	Treatment (Panitumumab, Chemotherapy, Radiation) n=11 Participants Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
Progression-free Survival	409 days Interval 119.0 to 2840.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From the first date of therapy until the date the patient dies, assessed up to 100 months

Descriptively summarized using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Panitumumab, Chemotherapy, Radiation) n=11 Participants Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
Overall Survival	596 days Interval 119.0 to 2840.0

Adverse Events

Treatment (Panitumumab, Chemotherapy, Radiation)

Serious events: 10 serious events

Other events: 11 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Panitumumab, Chemotherapy, Radiation) n=11 participants at risk Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
Blood and lymphatic system disorders Anemia	9.1% 1/11 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations Weight loss	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Vascular disorders Thromboembolic event	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders diarrhea	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Hypoxia	27.3% 3/11 • Number of events 6 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	27.3% 3/11 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders pulmonary edema	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Infections and infestations Lung infection	27.3% 3/11 • Number of events 5 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders nausea	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Vomiting	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders dehydration	18.2% 2/11 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Gastrointestinal disorders - Other	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Respiratory failure	18.2% 2/11 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Infections and infestations Sepsis	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Vascular disorders hypotension	27.3% 3/11 • Number of events 4 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Cardiac disorders bradycardia	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Cardiac disorders Pericarditis	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Cardiac disorders Chest pain - cardiac	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Small intestinal obstruction	9.1% 1/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
General disorders Fatigue	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders Anorexia	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Malabsorption	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Dyspnea	27.3% 3/11 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Aspiration	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Renal and urinary disorders Hematuria	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Nervous system disorders Depressed level of consciousness	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Surgical and medical procedures Surgical and medical procedures - Other	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders Hyponatremia	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders alcohol intolerance	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Psychiatric disorders suicidal ideation	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Psychiatric disorders hallucinations	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Psychiatric disorders depression	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
General disorders Non-cardiac chest pain	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations Troponin increase	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Typhlitis	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Blood and lymphatic system disorders Febrile Neutropenia	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
General disorders Fever	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Nervous system disorders Dizziness	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations lymphocyte count decreased	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders Acidosis	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders Alkalosis	9.1% 1/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Ileus	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Infections and infestations Infections and infestations - Other	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations Investigations - Other	9.1% 1/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
General disorders General disorders - Other	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
General disorders pain	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Hoarseness	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)

Other adverse events

Other adverse events
Measure	Treatment (Panitumumab, Chemotherapy, Radiation) n=11 participants at risk Patients receive panitumumab IV over 1 hour on day 1. Patients also receive oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours on day 1 (FOLFOX chemotherapy). Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 24 hours of the start of chemotherapy, patients undergo radiation therapy 5 days a week for 5.5 weeks. Patients then undergo surgery within 6-8 weeks after completion of radiation therapy. Patients with residual disease receive 4 additional courses of FOLFOX chemotherapy on days 1, 15, 29, and 42.
Metabolism and nutrition disorders Anorexia	72.7% 8/11 • Number of events 10 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders Hypokalemia	81.8% 9/11 • Number of events 19 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations lymphocyte count decreased	63.6% 7/11 • Number of events 36 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations White blood cells decreased	72.7% 8/11 • Number of events 18 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations Neutrophil count decreased	63.6% 7/11 • Number of events 13 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations Platelet cell count decreased	18.2% 2/11 • Number of events 5 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Diarrhea	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders hyperglycemia	27.3% 3/11 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Blood and lymphatic system disorders Anemia	63.6% 7/11 • Number of events 27 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Psychiatric disorders depression	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders dysphagia	36.4% 4/11 • Number of events 5 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders mucositis - oral	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Hoarseness	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders pleural effusion	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Infections and infestations Lung infection	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders Acidosis	9.1% 1/11 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders Hypoalbuminemia	36.4% 4/11 • Number of events 6 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations blood bilirubin increased	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders constipation	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Infections and infestations Infections and infestations - Other	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Nervous system disorders dysgeusia	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Blood and lymphatic system disorders Febrile neutropenia	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Nausea	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Ileus	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders hypophosphatemia	36.4% 4/11 • Number of events 5 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
General disorders Pain	18.2% 2/11 • Number of events 3 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Vascular disorders Hypotension	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Respiratory failure	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Nervous system disorders Depressed level of consciousness	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations INR increased	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders hypocalcemia	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Skin and subcutaneous tissue disorders Skin and subcutatneous tissue disorder - Other	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders hypoxia	27.3% 3/11 • Number of events 6 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders hyponatremia	9.1% 1/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Injury, poisoning and procedural complications - Other	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Esophageal pain	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations Aspartate aminotransferase increased	9.1% 1/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations Alanine aminotransferase	9.1% 1/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Metabolism and nutrition disorders Alkalosis	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	9.1% 1/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations weight loss	18.2% 2/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
General disorders Fatigue	9.1% 1/11 • Number of events 2 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Vascular disorders thromboembolic event	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations Electrocardiogram QT corrected interval prolonged	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)
Investigations Alkaline phosphatase increased	9.1% 1/11 • Number of events 1 • Patients were followed for adverse events from the time of first treatment until they 30 days after last day of study treatment. (approximately 10 weeks)

Additional Information

Jean L Grem

University of Nebraska Medical Center

Phone: 402-559-5166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place