NCT00419159

Brief Summary

To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 16, 2011

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

January 4, 2007

Results QC Date

December 17, 2010

Last Update Submit

April 11, 2019

Conditions

Colorectal Cancer

Keywords

Colorectal cancermetastatic colorectal adenocarcinomaanti-EGFR antibody

Outcome Measures

Primary Outcomes (2)

  • Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)

    RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response).

    Imaging every 8 weeks

  • The Number of Participants With Best Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST)

    RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Best Over Response (BOR): Complete Response (CR, No lesions), Partial Response (PR, 30% decrease in lesions), and Stable Disease (SD, none of the above)

    Imaging every 8 weeks

Secondary Outcomes (11)

  • Progression-free Survival (PFS)

    Imaging every 8 weeks

  • Overall Survival (OS)

    Every 3 months

  • Number of Patients Who Died, Had an Serious Adverse Event (SAE), Had Grade 3 to 4 Adverse Event (AE), Discontinued Due to an AE, or Had a Clinical Notable AE by Treatment (tr).

    From the first day of treatment until 28 days after discontinuation of study treatment

  • Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 70 mg/Week

    Screening and Day 1 of cycles 2, 3, 4 and end of treatment

  • Biomarker Predictive of Clinical Benefit (DCR by KRAS) on Everolimus (RAD001) 10 mg/Day

    Screening and Day 1 of cycles 2, 3, 4 and end of treatment

  • +6 more secondary outcomes

Study Arms (2)

Everolimus (RAD001) 70 mg/week

EXPERIMENTAL
Drug: Everolimus (RAD001)

Everolimus (RAD001) 10 mg/day

EXPERIMENTAL
Drug: Everolimus (RAD001)

Interventions

Everolimus (RAD001)DRUG

Everolimus was supplied in 5 mg tablets in blister packs.

Also known as: Afinitor, Zortress, Certican
Everolimus (RAD001) 10 mg/dayEverolimus (RAD001) 70 mg/week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old.
  • Patients with metastatic colorectal cancer (CRC).
  • Patients must have sufficient and obtainable tumor tissue for biomarker analysis from original surgical resection.
  • Patients with documented disease progression within 6 months of their most recent dose of chemotherapeutic regimens.
  • Patients with at least one measurable lesion.
  • Adequate bone marrow function.
  • Adequate liver function.
  • Adequate renal function.
  • Patients with a life expectancy of \> 3 months.
  • Patients with a World Health Organization (WHO) performance status of 0, 1, or 2.
  • Women of childbearing potential must have had a negative serum pregnancy test 72 hours prior to the administration of the first study treatment.
  • Patients who give a written informed consent obtained according to local guidelines.

You may not qualify if:

  • Patients currently receiving anti-cancer agents or who have received these within 4 weeks prior to study entry.
  • Patients who have previously received RAD001.
  • Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.
  • Chronic treatment with steroids or another immunosuppressive agent.
  • Patients with untreated central nervous system (CNS) metastases or neurologically unstable CNS metastases.
  • HIV seropositivity.
  • Patients with an active, bleeding diathesis. Patients may use enoxaparin.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
  • Patients who have a history of another primary malignancy \< 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
  • Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to first study treatment.
  • Patients unwilling to or unable to comply with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

December 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 23, 2019

Results First Posted

May 16, 2011

Record last verified: 2019-04

Locations

US(1)