Who is sponsoring NCT01148628?

NCT01148628 is sponsored by Southern Europe New Drug Organization.

What condition does NCT01148628 study?

NCT01148628 studies Advanced Solid Tumors.

What drugs are being tested in NCT01148628?

Interventions: RAD 001 in combination with Caelyx.

What is the status of NCT01148628?

NCT01148628 is currently UNKNOWN.

Last reviewed 2011-09-12 · How we verify

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

NCT01148628 Phase 1 UNKNOWN

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

Details

Lead sponsor	Southern Europe New Drug Organization
Phase	Phase 1
Status	UNKNOWN
Enrolment	54
Start date	2007-10
Completion	2011-12

Conditions

Advanced Solid Tumors

Interventions

RAD 001 in combination with Caelyx

Primary outcomes

Maximum Tolerated Dose (MTD) and Recommended Dose (RD) — 4 weeks
The Maximum Tolerated Dose (MTD) is defined as the dose in which 2 of 3 or 2 of 6 patients experience a Dose Limiting Toxicity (DLT).The Recommended Dose (RD) is defined as one dose level below the MTD.

Countries

Italy, Switzerland