Trial Outcomes & Findings for Everolimus in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Previous Therapy (NCT NCT00390364)

Last Updated: 2014-10-08

Results Overview

To determine response rate and time to tumor progression of patients with colorectal cancer and mutations in the PI3KCA gene who are treated with RAD001. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions assessed by CT (or MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesion. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion. The outcome measure will be the total number of subjects who show progression of disease.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

1 month

Results posted on

2014-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	RAD0001 Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Everolimus in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Previous Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RAD0001 n=1 Participants Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
Age, Continuous	38 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Outcome measures

Outcome measures
Measure	RAD0001 n=1 Participants Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
Response Rate: The Total Number of Participants With Progression of Disease	1 participants with progression of disease

Adverse Events

RAD0001

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	RAD0001 n=1 participants at risk Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
General disorders headache	100.0% 1/1
Infections and infestations sinus infection	100.0% 1/1
Skin and subcutaneous tissue disorders rash	100.0% 1/1
Metabolism and nutrition disorders hypokalemia	100.0% 1/1
Metabolism and nutrition disorders hyperglycemia	100.0% 1/1
Blood and lymphatic system disorders leukopenia	100.0% 1/1
Blood and lymphatic system disorders thrombocytopenia	100.0% 1/1
Blood and lymphatic system disorders lymphopenia	100.0% 1/1
Metabolism and nutrition disorders hypercholesterolemia	100.0% 1/1

Additional Information

Manuel Hidalgo, MD (no longer works at Hopkins)

Sidney Kimmel Comprehensive Cancer Center at JHMI

Phone: 410-502-5328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place