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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 has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00985374
First received: September 24, 2009
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This 2 part study will assess the safety, tolerability and efficacy of a combina tion of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanc ed 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 eve ry 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cel l cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maxim um 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: RAD001
Drug: RG1507
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:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 98229
Italy
Milano, Lombardia, 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: November 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014