Clincosm LogoSign in Get a demo

A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Terminated
CT.gov ID
NCT00985374
Collaborator
(none)
11
Enrollment
3
Locations
1
Arm
43
Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with

  1. advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multiple Ascending Dose (MAD) Phase Ib/II Study of the mTOR Inhibitor (RAD001) in Combination With the IGF-1R Antagonist (R1507) for the Treatment of Patients With Advanced Solid Tumors
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: RAD001
5mg or 10mg po daily

Drug: RG1507
16mg/kg iv every 3 weeks

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose of RAD001, in combination with R1507 (Part 1 [First 3 week cycle of treatment]

  2. Progression-free survival (Part 2) [24 weeks]

Secondary Outcome Measures

  1. Overall objective response rate; duration of response; overall survival [Event driven; monitored throughout study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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 Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York New York United States 10017
2 San Antonio Texas United States 98229
3 Milano Lombardia Italy 20133

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00985374
Other Study ID Numbers:
  • NO21884
  • 2008-005806-38
First Posted:
Sep 28, 2009
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Everolimus

Study Results

No Results Posted as of Nov 2, 2016