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

Phase 1

Terminated

• Conditions: Neoplasms
• Interventions: Drug: RAD001; Drug: RG1507

• Registration Number: NCT00985374
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Study Start: 2009-11
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	RAD001	-
1	RG1507	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (Part 2)	24 weeks
Maximum tolerated dose of RAD001, in combination with R1507 (Part 1	First 3 week cycle of treatment

Secondary Outcome Measures

Name	Time	Method
Overall objective response rate; duration of response; overall survival	Event driven; monitored throughout study