Clinical Study
A Phase I/II Clinical Trial of Belinostat (PXD101) in Combination with Doxorubicin in Patients with Soft Tissue Sarcomas
| | Characteristics | Patients |
| | Total number of patients | 41 |
| | Age (years) | | | Mean | 57.1 | | Range | (30–71) |
| | Gender | | | Female | 15 (37%) | | Male | 26 (63%) |
| | ECOG performance status | : 41 |
| | 0 | 23 | | 1 | 14 | | 2 | 4 |
| | Tumour type | DE (: 25) | MTD (: 16) |
| | Solid tumours, total | 15 | 0 | | Colorectal adenocarcinoma | 1 | 0 | | Non-small cell lung cancer | 1 | 0 | | Renal pelvis carcinosarcoma | 1 | 0 | | Pancreas adenocarcinoma | 1 | 0 | | Cholangiocarcinoma | 1 | 0 | | Cervix cell carcinoma | 1 | 0 | | Stromal tumour of unknown | 1 | 0 | | Anal planocellular carcinoma | 1 | 0 | | Ocular malignant melanoma | 3 | 0 | | Bladder carcinoma | 1 | 0 | | Renal carcinoma | 1 | 0 | | Squamous cell carcinoma | 1 | 0 | | Thyroid carcinoma | 1 | 0 |
| | Sarcomas, total | 10 | 16 | | Liposarcoma | 2 | 3 | | Leiomyosarcoma | 2 | 5 | | Chondrosarcoma | 1 | 3 | | Angiosarcoma | 1 | 1 | | Myxofibrosarcoma | 1 | 1 | | Undif pleomorphic sarcoma | 1 | 1 | | Rhabdomyosarcoma | 1 | 0 | | Fibrosarcoma | 1 | 0 | | Myogenic sarcoma | 0 | 1 | | Synovial sarcoma | 0 | 1 |
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DE: dose escalation phase I study.
MTD: maximum tolerated dose phase II study.
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