Background
Methods
Study medication
Study design
Objectives
Study population
Quality assurance
Adverse events (AEs), dose limiting toxicity (DLT) and maximum tolerable dose (MTD)
-
Grade 1: Transient rash, drug fever ≤39,8 °C for less than 24 h
-
Grade 2: Urticaria, and/or asymptomatic bronchospasm, drug fever >39,8 °C or drug fever >39.5 °C continuing more than 24 h
-
Grade 3: Symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema
-
Grade 4: Anaphylaxis
Safety and tolerability assessments
Sample size, statistics and data management
Results
Characteristics | |
---|---|
Age in years (median and range) | 64 (42–74) |
Gender (number of male and female patients) | 17 / 4 |
ECOG-performance status (number of patients) | |
0 | 5 |
1 | 12 |
2 | 4 |
Primary tumour (number of patients) | |
Prostate cancer | 4 |
Colorectal cancer | 3 |
Renal cell cancer | 2 |
Hepatocellular cancer | 2 |
Sarcoma | 2 |
Glioblastoma | 1 |
Lung cancer | 1 |
Stomach cancer | 1 |
Pancreatic cancer | 1 |
Gall bladder cancer | 1 |
Tonsil cancer | 1 |
Thyroid (C-cell) cancer | 1 |
Thrombocythemia | 1 |
Previous treatment (number of patients) | |
Surgery | 15 |
Chemotherapy | 14 |
Radiotherapy | 9 |
Immunotherapy | 4 |
Time since primary cancer diagnosis (years) | 6.7 ± 8.8 |
Body mass index (kg/m2) | 24.2 ± 5.6 |
Blood pressure (mmHg) | 126 ± 18 / 82 ± 11 |
Puls rate (Beats/min) | 72 ± 13 |
Rectal temperature (°C) | 36.6 ± 0.5 |
Dose in mg | Number of patients | Treatment duration (weeks) | DLT |
---|---|---|---|
200 | 3 | 3 | No |
400 | 3 | 3 | No |
700 | 3 | 3 | No |
1200 | 3 | 3 | No |
2000 | 3 | 3 | Yes (patient 15) |
2000 | 3 | 3 | No |
2000 | 3 | 9 | No |
Safety and tolerability
Rating | 200 mg | 400 mg | 700 mg | 1200 mga
| 2000 mga
|
---|---|---|---|---|---|
Number of infusions rated | 9 | 9 | 9 | 9 | 27 |
Very good | 100% | 33% | 0 | 44% | 33% |
Good | 0 | 22% | 56% | 33% | 33% |
Moderate | 0 | 44% | 44% | 0 | 26% |
Bad | 0 | 0 | 0 | 0 | 0 |
Very bad | 0 | 0 | 0 | 0 | 0 |
Dose (mg) | 200 | 400 | 700 | 1200 | 2000a
| 2000b
| 2000c
|
---|---|---|---|---|---|---|---|
Clinical AE (n) | 2 | 0 | 6 | 3 | 16 | 7 | 1 |
Laboratory AE (n) | 16 | 16 | 16 | 20 | 14 | 12 | 25 |