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Completed Phase 1Phase 2 Interventional Results available

RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer

ClinicalTrials.gov ID: NCT01058655

Public ClinicalTrials.gov record NCT01058655. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 11:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/II Study of RAD001 and AV-951 in Patients With Refractory, Metastatic Colorectal Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Research has shown that anti-angiogenic agents can be effective therapies to treat cancer. Anti-angiogenic agents target the blood vessels required for tumors to grow. Vascular endothelial growth factor (VEGF) is one of the cell pathways used for this blood vessel growth. When the investigators interfere with the VEGF pathway, the investigators inhibit this blood vessel growth which is required by tumors. One of the study drugs being used, tivozanib (AV-951), selectively interferes with the VEGF pathway. The second study drug being used, everolimus (RAD001) interferes with the mTOR pathway. The mTOR pathway is another pathway involved in blood vessel and tumor cell growth. By combining these two drugs the investigators hope to slow or reverse tumor cell growth in patients whose tumors have become resistant to other therapies for their disease.

Study identification

NCT ID
NCT01058655
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
56 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2010
Primary completion
Aug 31, 2013
Completion
Mar 31, 2015
Last update posted
Apr 12, 2017

2010 – 2015

United States locations

U.S. sites
3
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Massachusetts General Hospital Boston Massachusetts 02114
Beth Israel Deaconess Medical Center Boston Massachusetts 02115
Dana-Farber Cancer Institute Boston Massachusetts 02115

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01058655, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2017 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01058655 live on ClinicalTrials.gov.

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