Phase I dose-escalation study of S 78454 in patients with solid tumour

Phase 1

Completed

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

• Registration Number: ISRCTN96863717
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23790467

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-05-07
• Study Start: 2013-08-06
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female patient aged > or equal to 18
2. Solid tumour with measurable or evaluable disease, that has relapsed or is refractory to conventional standard forms of therapy
3. Ability to swallow oral capsule(s) without difficulty
4. Estimated life expectancy > 12 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status less or equal to 1
6. 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. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
5. 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
6. Concurrent therapeutic anticoagulation by anti-vitamin K (AVK)
7. Patients treated by valproic acid
8. Any other previous (in the last 3 years) or concurrent cancer, other than resected non-melanoma skin cancer or cancer in situ of the uterine cervix
9. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Maximum tolerated dose (MTD) <br>2. Dose limiting toxicity (DLT) of S 78454. This is evaluated at the end of cycle 1.

Secondary Outcome Measures

Name	Time	Method
1. Safety profile at each visit<br>2. Pharmacokinetics (PK) and pharmacodynamics (PD) parameters: PK parameters are evaluated in cycle 1, and PD parameters during cycle 1, cycle 2 and cycle 3<br>3. Tumour response at baseline and every 2 cycles