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Lenalidomide and Paclitaxel in Advanced Solid Tumors

NCT01155505 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

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) of the combination of CC-5013 (Lenalidomide)and paclitaxel in patients with advanced solid tumors.

Other purposes of the study are:

1. Define the safety profile of the CC-5013 and paclitaxel given in combination
2. Define the pharmacokinetics of CC-5013 and paclitaxel given in combination
3. Define the pharmacodynamic effects of the combination by monitoring potential biomarkers of the different biological activities of each component of the regimen
4. Define the optimal biological dose (OBD) and the dose recommended (RD) for phase II studies in selected tumor types (breast, ovary, prostate, NSCLC)
5. Collect evidence of antitumor activity in selected tumor types

Conditions

Interventions

DRUG

Lenalidomide (CC-5013)

CC-5013 given PO daily on D1-D14 every 21 days and Paclitaxel administered IV over 1 hour on d1 and 8 every 21 days until tumor progression or unacceptable toxicity

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Southern Europe New Drug Organization

    lead OTHER

Principal Investigators

  • Cristiana Sessa, MD · Istituto Oncologico della Svizzera Italiana -6500 Bellinzona, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-12-31
Completion
2012-03-31

Countries

  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT01155505 on ClinicalTrials.gov