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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00985374
Recruitment Status : Terminated
First Posted : September 28, 2009
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Neoplasms Drug: RAD001 Drug: RG1507 Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : November 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: RAD001
5mg or 10mg po daily

Drug: RG1507
16mg/kg iv every 3 weeks

Primary Outcome Measures :
  1. Maximum tolerated dose of RAD001, in combination with R1507 (Part 1 [ Time Frame: First 3 week cycle of treatment ]
  2. Progression-free survival (Part 2) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Overall objective response rate; duration of response; overall survival [ Time Frame: Event driven; monitored throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00985374

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United States, New York
New York, New York, United States, 10017
United States, Texas
San Antonio, Texas, United States, 98229
Milano, Lombardia, Italy, 20133
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT00985374    
Other Study ID Numbers: NO21884
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs