NCT01155505

Lenalidomide and Paclitaxel in Advanced Solid Tumors

Phase Ib of CC-5013 and Paclitaxel in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Southern Europe New Drug Organization · Academic / Other
• Sex: All
• Age: 18 Years – 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) 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

Detailed description

The new immunomodulatory drugs (IMiD) derivatives of thalidomide (CC-5013 lenalidomide and CC4047 pomalidomide) are endowed of direct antitumor activity besides the indirect effects attributed to antiangiogenic, antiinflammatory and T-cell co-stimulatory properties. Combination therapy with cytotoxic agents or other anticancer drugs could lead to additive or synergistic interactions and support their clinical development in tumor types in which the specific activities of IMiDs could be of potential value. Combinations with weekly paclitaxel could be of interest because of its antiangiogenic activity, antitumor activity in prostate, NSCLC, ovary, breast cancer, tumor types in which IMiD could be of clinical value because of either enhancement of tumor specific immunity (ovary, prostate) or inhibition of Treg function (breast, NSCLC, ovary).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-12-01
• Completion: 2012-03-01
• First posted: 2010-07-01
• Last updated: 2011-09-13

Locations

2 sites across 2 countries: Italy, Switzerland