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

NCT01148628 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2011-09-13

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • Southern Europe New Drug Organization

    lead OTHER

Principal Investigators

  • Cristiana Sessa, MD · Istituto Oncologico della Svizzera Italiana- Ospedale s.Giovanni - 6500 Bellinzona, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-03-31
Completion
2011-12-31

Countries

  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01148628 on ClinicalTrials.gov