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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00985374

Enrollment

Registered

2009-09-28

Start date

2009-11-30

Completion date

2013-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

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.

Interventions

DRUGRAD001

5mg or 10mg po daily

DRUGRG1507

16mg/kg iv every 3 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Overall objective response rate; duration of response; overall survival	Event driven; monitored throughout study

Countries

Italy, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026