Trial Outcomes & Findings for Phase I Trial of huA33 Plus Chemotherapy in Patients With Metastatic Colorectal Cancer (NCT NCT00199797)
NCT ID: NCT00199797
Last Updated: 2022-10-10
Results Overview
Patients were evaluated weekly for toxicity. Blood samples were obtained every week for hematology and serum biochemistry analysis. All adverse events, which occurred after the signing of informed consent were documented in the case report form. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0). All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 13.1 and classified by MedDRA system organ class (SOC) and preferred term. Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
up to 26 weeks
Results posted on
2022-10-10
Participant Flow
Participant milestones
| Measure |
huA33 Antibody Plus Chemotherapy
huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.
Starting on day 15 and continuing every second week, oxaliplatin, 5-fluorouracil (5-FU) and leucovorin were also administered.
Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as a bolus infusion and 600mg/m2 as a continuous infusion.
A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
huA33 Antibody Plus Chemotherapy
huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.
Starting on day 15 and continuing every second week, oxaliplatin, 5-fluorouracil (5-FU) and leucovorin were also administered.
Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as a bolus infusion and 600mg/m2 as a continuous infusion.
A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression.
|
|---|---|
|
Overall Study
Progressive Disease
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Phase I Trial of huA33 Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
huA33 Antibody Plus Chemotherapy
n=20 Participants
huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.
Starting on day 15 and continuing every second week, oxaliplatin, 5-fluorouracil (5-FU) and leucovorin were also administered.
Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as a continuous infusion.
A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression.
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 26 weeksPopulation: All patients who received at least one dose of huA33.
Patients were evaluated weekly for toxicity. Blood samples were obtained every week for hematology and serum biochemistry analysis. All adverse events, which occurred after the signing of informed consent were documented in the case report form. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0). All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 13.1 and classified by MedDRA system organ class (SOC) and preferred term. Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
Outcome measures
| Measure |
huA33 Antibody Plus Chemotherapy
n=20 Participants
huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.
Starting on day 15 and continuing every second week, oxaliplatin, 5-fluorouracil (5-FU) and leucovorin were also administered.
Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as a continuous infusion.
A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression.
|
|---|---|
|
Safety as Measured by the Number of Patients With Treatment Emergent Adverse Events (TEAEs), Grade 3 TEAEs, TEAEs Resulting in Death, TEAEs Related to Treatment and Serious TEAEs in Patients With Metastatic Colorectal Cancer.
Number of patients with treatment emergent adverse events
|
20 Participants
|
|
Safety as Measured by the Number of Patients With Treatment Emergent Adverse Events (TEAEs), Grade 3 TEAEs, TEAEs Resulting in Death, TEAEs Related to Treatment and Serious TEAEs in Patients With Metastatic Colorectal Cancer.
Number of patients with treatment emergent adverse events Grade 3 or above
|
17 Participants
|
|
Safety as Measured by the Number of Patients With Treatment Emergent Adverse Events (TEAEs), Grade 3 TEAEs, TEAEs Resulting in Death, TEAEs Related to Treatment and Serious TEAEs in Patients With Metastatic Colorectal Cancer.
Number of patients with treatment emergent adverse events which resulted in death
|
1 Participants
|
|
Safety as Measured by the Number of Patients With Treatment Emergent Adverse Events (TEAEs), Grade 3 TEAEs, TEAEs Resulting in Death, TEAEs Related to Treatment and Serious TEAEs in Patients With Metastatic Colorectal Cancer.
Number of patients with treatment emergent adverse events related to treatment
|
18 Participants
|
|
Safety as Measured by the Number of Patients With Treatment Emergent Adverse Events (TEAEs), Grade 3 TEAEs, TEAEs Resulting in Death, TEAEs Related to Treatment and Serious TEAEs in Patients With Metastatic Colorectal Cancer.
Number of patients with serious adverse events
|
11 Participants
|
SECONDARY outcome
Timeframe: up to 26 weeksPopulation: All patients who received at least one dose of huA33.
Serum samples were taken at baseline and prior to each administration of huA33.The samples were analyzed by surface plasmon resonance technology using a BIACORE 2000 instrument. All sera were analyzed at the end of the study. Patient serum was considered HAHA positive if the response unit (RU) value at a serum dilution of 1:100 exceeded a cutoff value, defined as the mean inter-patient baseline RU value + 3x the standard deviation (SD) of negative control sera at a serum dilution of 1:100. Results were reported as either positive or negative.
Outcome measures
| Measure |
huA33 Antibody Plus Chemotherapy
n=20 Participants
huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.
Starting on day 15 and continuing every second week, oxaliplatin, 5-fluorouracil (5-FU) and leucovorin were also administered.
Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as a continuous infusion.
A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression.
|
|---|---|
|
Immunogenicity of huA33 as Measured by the Number of Patients With Human Anti-human Antibodies (HAHA) When Given huA33 Together With Oxaliplatin and 5-FU Plus Leucovorin in Patients With Metastatic Colorectal Cancer.
Patients with positive HAHA response
|
6 Participants
|
|
Immunogenicity of huA33 as Measured by the Number of Patients With Human Anti-human Antibodies (HAHA) When Given huA33 Together With Oxaliplatin and 5-FU Plus Leucovorin in Patients With Metastatic Colorectal Cancer.
Patients with negative HAHA response
|
14 Participants
|
SECONDARY outcome
Timeframe: up to 26 weeksPopulation: Patients who received huA33 and were evaluable for response. One patient was not evaluable.
Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse P et al. J Natl Cancer Inst 92: 205-216 2000) at baseline and at the end of each cycle. Per RECIST, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria.
Outcome measures
| Measure |
huA33 Antibody Plus Chemotherapy
n=19 Participants
huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.
Starting on day 15 and continuing every second week, oxaliplatin, 5-fluorouracil (5-FU) and leucovorin were also administered.
Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards, patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as an bolus infusion and 600mg/m2 as a continuous infusion.
A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression.
|
|---|---|
|
Tumor Response in Patients With Metastatic Colorectal Cancer Receiving huA33, Oxaliplatin and 5-FU Plus Leucovorin.
Complete Response
|
1 Participants
|
|
Tumor Response in Patients With Metastatic Colorectal Cancer Receiving huA33, Oxaliplatin and 5-FU Plus Leucovorin.
Partial Response
|
7 Participants
|
|
Tumor Response in Patients With Metastatic Colorectal Cancer Receiving huA33, Oxaliplatin and 5-FU Plus Leucovorin.
Stable Disease
|
4 Participants
|
|
Tumor Response in Patients With Metastatic Colorectal Cancer Receiving huA33, Oxaliplatin and 5-FU Plus Leucovorin.
Progressive Disease
|
7 Participants
|
Adverse Events
huA33 Antibody Plus Chemotherapy
Serious events: 11 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
huA33 Antibody Plus Chemotherapy
n=20 participants at risk
huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.
Starting on day 15 and continuing every second week, oxaliplatin,5-fluorouracil (5-FU) and leucovorin were also administered.
Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as a bolus infusion and 600mg/m2 as a continuous infusion.
A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression.
|
|---|---|
|
General disorders
Sudden death
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Chills
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Pyrexia
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Immune system disorders
Hypersensitivity
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Performance status decreased
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Vascular disorders
Arterial thrombosis limb
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Surgical and medical procedures
Catheter placement
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Surgical and medical procedures
Chemotherapy
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Infections and infestations
Device related infection
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
5.0%
1/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
Other adverse events
| Measure |
huA33 Antibody Plus Chemotherapy
n=20 participants at risk
huA33 was administered intravenously over a period of 30 minutes once a week at a dose of 10 mg/m2 for 12 weeks.
Starting on day 15 and continuing every second week, oxaliplatin,5-fluorouracil (5-FU) and leucovorin were also administered.
Oxaliplatin and leucovorin were given as infusions over 2 hours. Afterwards patients received a bolus infusion of 5-FU intravenously followed by an infusion of 5-FU over 22 hours.
The doses of oxaliplatin were 85mg/m2, leucovorin 200mg/m2, 400mg/m2 of 5-FU as a bolus infusion and 600mg/m2 as a continuous infusion.
A complete treatment cycle consisted of 12 weeks. Patients were eligible to receive an additional cycle in the absence of dose-limiting toxicity (DLT), immunogenicity (huA33 human anti-human antibodies {HAHA}) and disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
65.0%
13/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
6/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
5/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
5/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Cardiac disorders
Bradycardia
|
20.0%
4/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Cardiac disorders
Dyspnoea exertional
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Cardiac disorders
Tachycardia
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
15.0%
3/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Nausea
|
70.0%
14/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
10/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Constipation
|
45.0%
9/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
3/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
4/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Dysgeusia
|
15.0%
3/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
8/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Fatigue
|
45.0%
9/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Mucosal inflammation
|
30.0%
6/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Pyrexia
|
20.0%
4/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Pain
|
20.0%
4/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Chills
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Asthenia
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
General disorders
Oedema peripheral
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
15.0%
3/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Infections and infestations
Sinusitis
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Investigations
Weight decreased
|
20.0%
4/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Investigations
Blood creatinine increased
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Investigations
C-reactive protein increased
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Investigations
Respiratory rate increased
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
4/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
4/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Nervous system disorders
Polyneuropathy
|
45.0%
9/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
15.0%
3/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
5/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
15.0%
3/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
2/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Vascular disorders
Hypotension
|
35.0%
7/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
|
Vascular disorders
Hypertension
|
25.0%
5/20 • up to 26 weeks
All adverse events which occurred after signing informed consent were documented in the source records and on the respective case report form, regardless of the assumption of a causal relationship. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale (Version 3.0).Treatment emergent adverse events (TEAEs) are any adverse events occurring or worsening after the first administration of study drug.
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: 12124501539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place