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


Tracking Information

Start Date  ICMJENovember 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: September 25, 2009)
  • Maximum tolerated dose of RAD001, in combination with R1507 (Part 1 [ Time Frame: First 3 week cycle of treatment ] [ Designated as safety issue: No ]
  • Progression-free survival (Part 2) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00985374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 15, 2009)
Overall objective response rate; duration of response; overall survival [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: September 25, 2009)
  • Overall objective response rate [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJEA Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors
Official Title  ICMJEMultiple 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
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.

Detailed Description 
Study PhasePhase I
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJENeoplasms
Intervention  ICMJE
  • Drug: R1507
    16mg/kg iv every 3 weeks
  • Drug: RAD001
    5mg or 10mg po daily
Study Arms / Comparison Groups1: Experimental
Interventions:
  • Drug: R1507
  • Drug: RAD001

Recruitment Information

Estimated Enrollment  ICMJE144
Estimated Completion DateOctober 2010
Primary Completion Date 
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: NO21884888-662-6728 (U.S. Only)genentechclinicaltrials@druginfo.com
Location Countries  ICMJEUnited States,   Brazil,   Italy,   Russian Federation,   Spain

Administrative Information

NCT ID  ICMJENCT00985374
Responsible PartyDisclosures Group, Hoffmann-La Roche
Study ID Numbers  ICMJENO21884, 2008-005806-38
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche
Information Provided ByHoffmann-La Roche