Phase I study of S 78454 in combination with radiotherapy in patients with solid tumour

Phase 1

Completed

• Conditions: Solid tumours; Cancer

• Registration Number: ISRCTN48760309
• Lead Sponsor: Pharmacyclics LLC (USA)

Brief Summary

2016 results in https://www.ncbi.nlm.nih.gov/pubmed/28915584

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-30
• Study Completion: 2015-08-07
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Solid tumour, with measurable or evaluable disease, requiring a course of hypofractionated radiotherapy
2. Ability to swallow oral capsule(s) without difficulty
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
4. Estimated life expectancy of more than 20 weeks
5. Adequate haematological, renal and hepatic functions

Exclusion Criteria

1. Allogenic bone marrow transplant
2. Major surgery within previous 4 weeks
3. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas)
4. Previous radiotherapy on the same area
5. Cumulative radiation therapy involving more than 25% of the total bone marrow
6. Immunotherapy or hormonotherapy within previous 2 weeks, except stable luteinizing hormone-releasing hormone (LHRH) agonist therapy for prostate cancer, stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, stable mitotane for adrenal carcinoma, or oral contraceptives
7. Concurrent therapeutic anticoagulation by Vitamin K antagonists
8. Patients treated by valproic acid
9. Risk factors for, or use of medications known to prolong QTc interval and that may be associated with Torsades de Pointes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified