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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of RAD001, in combination with R1507 (Part 1

Outcome Time Frame:

First 3 week cycle of treatment

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO21884

NCT ID:

NCT00985374

Start Date:

November 2009

Completion Date:

June 2013

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Albany, New York  12208
Austin, Texas  78705