Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors

NCT01122199 | Completed Phase 1 DMC

• 1 other identifier: 1002-16; IUCRO-0287
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety of the combination of two drugs called RAD001 and AMG479. This study will see what effects (good and bad) RAD001 and AMG479 have on cancer. This study will also find the highest doses of RAD001 and AMG479 that can be given without causing severe side effects.

Conditions

Neoplasm Metastases

Outcome Measures

Primary Outcomes (2)

• To determine the maximum tolerated (MTD) and recommended Phase II doses for AMG479 and RAD001 in patients with refractory solid tumors

  1 year

• To evaluate the grade and severity of adverse events as a measure of safety and toxicity

  2 years

Secondary Outcomes (1)

• To determine preliminary antitumor efficacy of AMG479 and RAD001 in solid tumors

  5-10 years

Study Arms (1)

Open Label

EXPERIMENTAL

RAD001+ AMG479

Drug: RAD001 + AMG479

Interventions

RAD001 + AMG479 DRUG

Escalating doses of RAD001 + AMG479. Starting cohort will be 5 mg RAD001 once daily, continuous + AMG479 12 mg/kg on Day 1 and 15 of each 28 day cycle.

Also known as: everolimus + ganitumab

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shadia Jalal: lead
• Amgen: collaborator
• Novartis: collaborator

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Everolimus; ganitumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Shadia I Jalal, MD

  Indiana University Melvin and Bren Simon Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 13, 2010
• Study Start: May 14, 2010
• Primary Completion: January 19, 2015
• Study Completion: January 19, 2015
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

US (1)