Trial · NCT01767857
A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
NCT01767857, Phase 3, Terminated, Janssen Research & Development, LLC; results first posted 2021-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer. Trials, record NCT01767857. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01767857
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
- NCT number
- NCT01767857
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 643 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Xilonix, Placebo
- First posted
- 2013-01-14
- Last updated
- 2021-06-29
- Results first posted
- 2021-06-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 18 months | Overall survival time was defined as the duration from the date of randomization until death or last follow-up. OS was summarized by Kaplan-Meier method and compared between the treatment groups using un-adjusted log-rank test. |
| Secondary | Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans | Baseline and Week 8 | Change from baseline in LBM as measured by Dexa scans was reported. DEXA is an X-ray imaging modality used to determine the mass of one material in the presence of another material, using the knowledge of their unique X-ray attenuation at different energies. |
| Secondary | Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Baseline and Week 8 | The EORTC QLQ-C30 questionnaire incorporates nine multi-item scales: 5 functional scales (physical, cognitive, role, emotional, and social); 3 symptom scales (pain, fatigue, and appetite loss) and a Global Health Status/QoL scale. Each item, except Global Health Status, is answered on a four-point scale (1-4): 1-not at all, 2-a little, 3-quite a bit, 4-very much. Response to Global Health Status is measured on a 1 to 7 scale. "1" being very poor and "7" being excellent. Each scale (symptom scale \[pain, fatigue, and appetite loss\] and Global Health Status/Quality of Life \[QoL\] scale) was linearly transformed to be in range from 0-100 where a higher score represents good health status, while lower scores indicate poor health status. As planned, the data for symptom scales (pain, fatigue, appetite loss) and a Global Health Status/QoL scale was evaluated and reported. |
| Secondary | Change From Baseline in Platelet Counts | Baseline and Week 8 | Change from baseline in platelet counts up to Week 8 was evaluated. |
| Secondary | Progression Free Survival (PFS) | Up to 18 Months | PFS was defined as time from randomization to tumor progression or death. Progressive Disease defined as increase in tumor burden greater than or equals to (\>=) 25 (%) percent relative to nadir (minimum recorded tumor burden) confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented. Participants surviving without disease progression at end of study were censored. PFS was compared by Kaplan-Meier method using log-rank test. |
| Secondary | Percentage of Participants With Objective Response (OR) | Up to 18 months | The percentage of OR was estimated by dividing the total number of confirmed complete response (CR) and partial response (PR) by the total number of participants randomized where CR was complete disappearance of all lesions (whether measurable or not, and no new lesions); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented and PR was decrease in tumor burden \>= 50 % relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation. |
| Secondary | Percentage of Participants With Disease Control | Up to 18 months | Percentage of participants who achieved disease control was estimated by dividing the total number of confirmed CRs, PRs and stable disease (SD) by the total number of participants randomized where CR was complete disappearance of all lesions (whether measurable or not, and no new lesions); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented, PR was decrease in tumor burden \>= 50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation and SD defined as not meeting criteria for CR and PR, in absence of Progressive Disease (increase in tumor burden \>= 25 % relative to nadir (minimum recorded tumor burden) confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to 18 months | The modified intent-to-treat (mITT) population included all participants who were randomized and received at least one infusion of study drug. | Months | MEDIAN |
| SECONDARY | Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans | Baseline and Week 8 | The per protocol (PP) population was defined as participants that had baseline and follow up values for both the DEXA assessment and the European Organization for Research and Treatment of Cancer (EORTC) questionnaire. | kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Baseline and Week 8 | The PP population was defined as participants that had baseline and follow up values for both the DEXA assessment and the EORTC questionnaire. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Platelet Counts | Baseline and Week 8 | The PP population was defined as participants that had baseline and follow up values for both the DEXA assessment and the EORTC questionnaire. | 1000 cells/cubic millimeter | LEAST_SQUARES_MEAN |
| SECONDARY | Progression Free Survival (PFS) | Up to 18 Months | The intent-to-treat (ITT) population consisted of all randomized participants. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response (OR) | Up to 18 months | The mITT population included all participants who were randomized and received at least one infusion of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control | Up to 18 months | The participants with baseline and follow up radiographic assessments were included in this analysis. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Xilonix | 5.6 | 95% Confidence Interval 4.9 to 6.2 | Months | |
| Overall Survival (OS) | Placebo | 5.4 | 95% Confidence Interval 4.6 to 6.2 | Months | |
| Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans | Xilonix | 0.51 | Standard Error 0.158 | kilogram (kg) | |
| Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans | Placebo | -0.21 | Standard Error 0.231 | kilogram (kg) | |
Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Xilonix | Global Health Status/Qol | -6.64 | Standard Error 1.392 | Units on a scale |
Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Placebo | Global Health Status/Qol | -8.16 | Standard Error 2.041 | Units on a scale |
Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Xilonix | Pain | 8.50 | Standard Error 1.707 | Units on a scale |
Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Placebo | Pain | 10.27 | Standard Error 2.503 | Units on a scale |
Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Xilonix | Fatigue | 7.42 | Standard Error 1.516 | Units on a scale |
Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) | Placebo | Fatigue | 8.82 | Standard Error 2.223 | Units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Xilonix | 430 | |
| Overall Study | STARTED | Placebo | 213 | |
| Overall Study | Treated | Xilonix | 411 | |
| Overall Study | Treated | Placebo | 200 | |
| Overall Study | COMPLETED | Xilonix | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Xilonix | 430 | |
| Overall Study | NOT COMPLETED | Placebo | 213 |
Source ClinicalTrials.gov
Adverse events318
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 | Anaemia | Blood and lymphatic system disorders | Xilonix | 42 | 411 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 20 | 200 | |
| other | Sinus Tachycardia | Cardiac disorders | Xilonix | 11 | 411 | |
| other | Sinus Tachycardia | Cardiac disorders | Placebo | 10 | 200 | |
| other | Abdominal Pain | Gastrointestinal disorders | Xilonix | 78 | 411 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 41 | 200 | |
| other | Constipation | Gastrointestinal disorders | Xilonix | 51 | 411 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 31 | 200 | |
| other | Diarrhoea | Gastrointestinal disorders | Xilonix | 45 | 411 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 22 | 200 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Xilonix | 28 | 411 |
| Total, all-cause mortality | Placebo | 13 | 200 |
| Total, other adverse events | Xilonix | 324 | 411 |
| Total, other adverse events | Placebo | 167 | 200 |
| Total, serious adverse events | Xilonix | 169 | 411 |
| Total, serious adverse events | Placebo | 84 | 200 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24746841 | BACKGROUND |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Xilonix vs Placebo: deaths from any cause | Trial comparisons |
| Xilonix vs Placebo: serious adverse events | Trial comparisons |
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/NCT01767857
GET https://conductscience.org/api/trials/v1/NCT01767857/events?page=2