Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01122199
• Date of registration: 07/05/2010
• Prospective Registration: Yes
• Primary sponsor: Shadia Jalal
• Public title: Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors
• Scientific title: Phase I Study of mTOR Inhibitor RAD001 in Combination With IGF-1R Inhibitor AMG479 for Patients With Advanced Solid Tumors
• Date of first enrolment: May 14, 2010
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01122199
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Shadia I Jalal, MD
• Affiliation: Indiana University Melvin and Bren Simon Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histological or cytological proof of metastatic solid tumor refractory to standard
therapies, or for which no standard therapies are available.

- Patients in the expansion cohort must have a measurable site of disease according to
RECIST (v 1.0)

- Laboratory values must be obtained within protocol limits and obtained within 14 days
prior to registration

- Patients must have disease which is not amenable to potentially curative surgical
resection of metastatic disease (curative metastasectomy).

- Must be willing to provide metastatic tissue biopsy samples (may be paraffin embedded)
at baseline

- Must be willing to undergo a metastatic tissue biopsy after 2 cycles of therapy to
perform pharmacodynamic research biomarkers testing.

- Subjects must be willing and able to abstain from using strong or moderate CYP3A4
inhibitors or inducers during the study period.

Exclusion Criteria:

- No symptomatic brain metastasis

- No prior treatment with an mTOR inhibitor or with an IGF-1R inhibitor

- No known history of diabetes mellitus

- No thrombosis or vascular ischemic events within the last twelve months

- No chronic treatment with systemic steroids or another immunosuppressive agent

- No active bleeding or a pathological condition that is associated with a high risk of
bleeding

- No known history of HIV seropositivity

- No known history of Hepatitis B or Hepatitis C seropositivity

- No known hypersensitivity to AMG 479, RAD001 (everolimus), other rapamycins
(sirolimus, temsirolimus), or to its excipients

- No planned immunization with attenuated live viruses during the study period



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neoplasm Metastases

Intervention(s)

Drug: RAD001 + AMG479

Primary Outcome(s)

To determine the maximum tolerated (MTD) and recommended Phase II doses for AMG479 and RAD001 in patients with refractory solid tumors [Time Frame: 1 year]

To evaluate the grade and severity of adverse events as a measure of safety and toxicity [Time Frame: 2 years]

Secondary Outcome(s)

To determine preliminary antitumor efficacy of AMG479 and RAD001 in solid tumors [Time Frame: 5-10 years]

Secondary ID(s)

1002-16; IUCRO-0287

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Amgen

Novartis