A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors
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
2 other identifiers
interventional
11
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2009
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedNovember 2, 2016
November 1, 2016
3.6 years
September 24, 2009
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum tolerated dose of RAD001, in combination with R1507 (Part 1
First 3 week cycle of treatment
Progression-free survival (Part 2)
24 weeks
Secondary Outcomes (1)
Overall objective response rate; duration of response; overall survival
Event driven; monitored throughout study
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
New York, New York, 10017, United States
Unknown Facility
San Antonio, Texas, 98229, United States
Unknown Facility
Milan, Lombardy, 20133, Italy
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2009
First Posted
September 28, 2009
Study Start
November 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11