Phase I dose escalation study with sorafenib in combination with sirolimus in patients with solid tumor.

• Conditions: 10027655; malignant solid tumors

• Registration Number: NL-OMON30326
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1. Patients with histological or cytological confirmed advanced solid tumor, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a combination of sorafenib and sirolimus (especially metastic RCC, malignant melanoma, HCC, NSCLC, pancreatic cancer, hormone refractory prostate cancer).
2. Men or women of at least 18 years
3. Patients who have an ECOG status of 0 or 1
4. Patients who have a life expectancy of at least 12 weeks
5. Adequate bone marrow, liver and renal function

Exclusion Criteria

1. History of serious cardiac disease
2. Active clinically serious bacterial, viral or fungal infections (> grade 2).
3. Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
4. Clinically symptomatic brain or meningeal metastasis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Critria for evaluation<br /><br>Safety profile<br /><br>The primary end point is to identify the recommended doses for the combination<br /><br>of sorafenib and sirolimus for subsequent phase II studies.<br /><br>Evaluation of DLT*s will be done. Adverse events will be scored using CTC AE v3.<br /><br>Efficacy<br /><br>There will be a descriptive analysis of proportion of patients with response or<br /><br>stable disease. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>