Status:
TERMINATED
A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study,...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- histologically confirmed recurrent or refractory advanced solid tumor (Part 1);
- advanced metastatic renal cell cancer OR advanced metastatic pancreatic neuroendocrine tumors, with evidence of progressive disease (Part 2);
- measurable disease (Part 2);
- ECOG performance status 0-2.
Exclusion
- prior treatment with agents acting via inhibition of IGF-IR pathway;
- prior treatment with agents acting via inhibition of mTOR (Part 2);
- untreated CNS metastases;
- current anti-cancer therapy, or radiotherapy or chemotherapy \<=4 weeks prior to enrollment;
- other known malignancy requiring treatment.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00985374
Start Date
November 1 2009
End Date
June 1 2013
Last Update
November 2 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
New York, New York, United States, 10017
2
San Antonio, Texas, United States, 98229
3
Milan, Lombardy, Italy, 20133