Phase I study of oral administration of S 78454 in association with doxorubicin in patients with solid tumour

Phase 1

Completed

• Conditions: Solid tumours; Cancer; Malignant neoplasm, unspecified

• Registration Number: ISRCTN55052510
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-24
• Study Completion: 2013-11-15
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Solid tumour, with measurable or evaluable disease, that has relapsed or is refractory to conventional, standard forms of therapy
2. Ability to swallow oral capsule(s) without difficulty
3. Estimated life expectancy > 12 weeks
4. Eastern Cooperative Oncology Group (ECOG) performance status < or equal to 1
5. Adequate haematological, renal and hepatic functions

Exclusion Criteria

1. Major surgery within previous 4 weeks
2. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas)
3. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
4. Immunotherapy or hormonotherapy within previous 2 weeks, except stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, or oral contraceptives or hormonal replacement therapy
5. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes
6. Patients treated by valproic acid within previous 5 days
7. Phenytoin (and by extension fosphenytoin) within previous 3 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) at each visit - Methods used: blood samples, physical examination, electrocardiogram (ECG)<br>2. Safety profile of the combination at each visit

Secondary Outcome Measures

Name	Time	Method
1. Tumour response at baseline evaluation every 2 cycles using the Response Evaluation Criteria In Solid Tumors (RECIST) guideline<br>2. Pharmacokinetic parameters during cycle 1 and 2 by blood samples<br>3. Pharmacodynamic parameters during cycle1 by blood samples and tumour biopsies