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

NCT ID: NCT00985374

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

RAD001

Intervention Type DRUG

5mg or 10mg po daily

RG1507

Intervention Type DRUG

16mg/kg iv every 3 weeks

Interventions

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RAD001

5mg or 10mg po daily

Intervention Type DRUG

RG1507

16mg/kg iv every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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New York, New York, United States

Site Status

San Antonio, Texas, United States

Site Status

Milan, Lombardy, Italy

Site Status

Countries

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Australia Brazil Czechia France Germany Russia Slovakia Spain United Kingdom United States Italy

Other Identifiers

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2008-005806-38

Identifier Type: -

Identifier Source: secondary_id

NO21884

Identifier Type: -

Identifier Source: org_study_id