Trial · NCT01047293
RAD001, FOLFOX and Bevacizumab in Treatment of Colorectal Carcinoma
NCT01047293, Phase 1, Phase 2, Completed, University of Utah; results first posted 2017-03-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RAD001, FOLFOX and Bevacizumab in Treatment of Colorectal Carcinoma. Trials, record NCT01047293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01047293
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RAD001, FOLFOX and Bevacizumab in Treatment of Colorectal Carcinoma
- NCT number
- NCT01047293
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Colorectal Cancer
- Interventions
- RAD001, FOLFOX, Bevacizumab
- First posted
- 2010-01-12
- Last updated
- 2017-04-04
- Results first posted
- 2017-03-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival at Six Months | 6 months | |
| Primary | Evaluate Safety of the Combination at a Daily Dosing of 2.5mg RAD001, 5 mg RAD001 or 10 mg RAD001 (Phase 1 Part) | December 2011 | Number of patients who experienced a Dose Limiting Toxicity (DLT). DLT will be assessed in the first 28 days of dosing. Patients need to get dosed with 2 rounds/sessions of all chemotherapy agents in the first 28 days in order to be evaluable for DLT assessment. The primary endpoint is safety as summarized by dose limiting toxicity (DLT). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival at Six Months | 6 months | Progression free survival at six month was calculated using all patients receiving one dose of drug therapy at all of the different dosing levels. The six month progression free survival was determined using Kaplan Meier methods | percentage of participants | NUMBER |
| PRIMARY | Evaluate Safety of the Combination at a Daily Dosing of 2.5mg RAD001, 5 mg RAD001 or 10 mg RAD001 (Phase 1 Part) | December 2011 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival at Six Months | All Patients | 87 | 95% Confidence Interval 76 to 99.9 | percentage of participants | |
| Evaluate Safety of the Combination at a Daily Dosing of 2.5mg RAD001, 5 mg RAD001 or 10 mg RAD001 (Phase 1 Part) | ARM 1 RAD001 5 mg QOD | 0 | participants | ||
| Evaluate Safety of the Combination at a Daily Dosing of 2.5mg RAD001, 5 mg RAD001 or 10 mg RAD001 (Phase 1 Part) | ARM 2 5mg RAD001 QD | 1 | participants | ||
| Evaluate Safety of the Combination at a Daily Dosing of 2.5mg RAD001, 5 mg RAD001 or 10 mg RAD001 (Phase 1 Part) | ARM 3 10mg RAD001 QD | 1 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ARM 1 RAD001 5 mg QOD | 4 | |
| Overall Study | STARTED | ARM 2 5mg RAD001 QD | 8 | |
| Overall Study | STARTED | ARM 3 10mg RAD001 QD | 9 | |
| Overall Study | STARTED | ARM 4 10mg RAD001 QD - Phase II | 26 | |
| Overall Study | COMPLETED | ARM 1 RAD001 5 mg QOD | 3 | |
| Overall Study | COMPLETED | ARM 2 5mg RAD001 QD | 7 | |
| Overall Study | COMPLETED | ARM 3 10mg RAD001 QD | 9 | |
| Overall Study | COMPLETED | ARM 4 10mg RAD001 QD - Phase II | 26 | |
| Overall Study | NOT COMPLETED | ARM 1 RAD001 5 mg QOD | 1 | |
| Overall Study | NOT COMPLETED | ARM 2 5mg RAD001 QD | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events122
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | body aches | General disorders | All Patients | 3 | 47 | 4 |
| other | alkaline phosphatase increased | Metabolism and nutrition disorders | All Patients | 6 | 47 | 7 |
| other | allergic reaction - anaphylactic | Immune system disorders | All Patients | 4 | 47 | 5 |
| other | alopecia | Skin and subcutaneous tissue disorders | All Patients | 11 | 47 | 12 |
| other | Alanine aminotransferase increased | Investigations | All Patients | 6 | 47 | 8 |
| other | anemia | Blood and lymphatic system disorders | All Patients | 12 | 47 | 22 |
| other | anorexia | Gastrointestinal disorders | All Patients | 25 | 47 | 52 |
| other | anxiety | Psychiatric disorders | All Patients | 3 | 47 | 4 |
| other | arthralgia | Musculoskeletal and connective tissue disorders | All Patients | 4 | 47 | 4 |
| other | Aspartate aminotransferase increased | Investigations | All Patients | 5 | 47 | 6 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | ||
| Total, other adverse events | All Patients | 47 | 47 |
| Total, serious adverse events | All Patients | 18 | 47 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30302599 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01047293
GET https://conductscience.org/api/trials/v1/NCT01047293/events?page=2