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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00985374
First received: September 24, 2009
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Neoplasms
 Drug: RG1507
Drug: RAD001
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Overall objective response rate; duration of response; overall survival [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: November 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG1507
16mg/kg iv every 3 weeks
Drug: RAD001
5mg or 10mg po daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985374

Locations
United States, New York
New York, New York, United States, 10065
United States, Texas
San Antonio, Texas, United States, 78229
Italy
Milano, Italy, 20133
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00985374     History of Changes
Other Study ID Numbers: NO21884, 2008-005806-38
Study First Received: September 24, 2009
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013