NCT01148628

Dose-finding Study of CAELYXTM and RAD001 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Southern Europe New Drug Organization · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose (RD) of the combination RAD001 (escalating daily dose) and CaelyxTM (fixed dose) to patients with advanced solid tumors. Other purposes of the study are: 1. define the safety profile of the combination after repeated administrations 2. define hints of antitumor activity, to be confirmed in subsequent disease-oriented expansion phases at the RD. 3. define the pharmacokinetic profile of the combination

Detailed description

mTOR inhibitors are a new class of targeted antitumor agents which showed interesting antitumor activity in a variety of solid tumors, including prostate, soft tissue sarcomas , ovarian, endometrial, kidney, and breast cancer. They also exert an antiangiogenic effect and are almost devoid of bone marrow toxicity as single agents which makes them suitable for combination with cytotoxic drugs. Anthracyclines are among the most used and effective cytotoxic agents, and in solid tumors their indications include, among others, breast, ovary, endometrial, prostate cancer. Liposomal Doxorubicin (CaelyxTM) could be an adequate replacement of doxorubicin to avoid potential side effects such as cardiotoxicity, alopecia, GI toxicity. Testing a combination regimen including mTOR inhibitors and anthracyclines in those tumors which are known to be sensitive to both compounds is of high clinical interest and worthwhile.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	RAD 001 in combination with Caelyx	RAD001 (tablets; 2.5mg) is administered daily at 5, 7.5, 10 mg. CAELYXTM (vials; 50 mg/25mL)is administered i.v.every 4 weeks at 40mg/m2. One treatment cycle is 4 weeks.

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-03-01
• Completion: 2011-12-01
• First posted: 2010-06-22
• Last updated: 2011-09-13

Locations

3 sites across 2 countries: Italy, Switzerland