Trial · NCT00537381
An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
NCT00537381, Phase 2, Completed, Centocor, Inc.; results first posted 2013-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer. Trials, record NCT00537381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00537381
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
- NCT number
- NCT00537381
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 131 participants, actual
- Lead sponsor
- Centocor, Inc.
- Conditions
- Prostatic Neoplasms
- Interventions
- Docetaxel, Prednisone, Intetumumab, Placebo
- First posted
- 2007-10-01
- Last updated
- 2013-06-20
- Other registries' IDs
- eudract:2006-005766-39
- Results first posted
- 2013-05-20
- Limitations and caveats
Treatment with intetumumab/placebo was permanently discontinued after a planned, preliminary review of interim analysis data. Therefore, study treatment with intetumumab was not completed for some participants.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Baseline up to 6 months after last dose of study treatment, assessed up to 551 days | The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. |
| Secondary | Number of Participants With Best Overall Response (OR) | Baseline up to 6 months after last dose of study treatment, assessed up to 551 days | Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. |
| Secondary | Number of Participants With Prostate Specific Antigen (PSA) Response | Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days | The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later). |
| Secondary | Overall Survival | Baseline until death (up to 887 days) | Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date. |
| Secondary | Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration | Baseline, Week 6, 7, 10 and 13 | Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. |
| Secondary | Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration | Baseline, Week 6, 7, 10 and 13 | Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. |
| Secondary | Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration | Baseline, Week 6, 7, 10 and 13 | Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100. |
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 | Progression-Free Survival (PFS) | Baseline up to 6 months after last dose of study treatment, assessed up to 551 days | Efficacy population included all participants randomly assigned to study treatment. | Days | MEDIAN |
| SECONDARY | Number of Participants With Best Overall Response (OR) | Baseline up to 6 months after last dose of study treatment, assessed up to 551 days | Response evaluable population included participants who had target lesion or non-target lesion at baseline and received at least 1 study treatment and had at least 1 post-baseline response assessment or discontinued study treatment due to disease progression, or death. | Participants | NUMBER |
| SECONDARY | Number of Participants With Prostate Specific Antigen (PSA) Response | Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days | Included all participants randomly assigned to study treatment and had baseline PSA evaluation and at least two post-baseline evaluations that are at least 3 weeks apart. | Participants | NUMBER |
| SECONDARY | Overall Survival | Baseline until death (up to 887 days) | Efficacy population included all participants randomly assigned to study treatment. | Days | MEDIAN |
| SECONDARY | Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration | Baseline, Week 6, 7, 10 and 13 | The pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration | Baseline, Week 6, 7, 10 and 13 | The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively. | Percent change | MEAN |
| SECONDARY | Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration | Baseline, Week 6, 7, 10 and 13 | The PD analysis set included all participants who received at least 1 dose of study treatment and had at least 1 PD measurement. Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively. | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Docetaxel + Prednisone + Placebo | 336.0 | 95% Confidence Interval 266.0 to 477.0 | Days | |
| Progression-Free Survival (PFS) | Docetaxel + Prednisone + Intetumumab | 232.0 | 95% Confidence Interval 155.0 to 320.0 | Days | |
| Number of Participants With Best Overall Response (OR) | Docetaxel + Prednisone + Placebo | Complete Response | 1 | Participants | |
| Number of Participants With Best Overall Response (OR) | Docetaxel + Prednisone + Intetumumab | Complete Response | 0 | Participants | |
| Number of Participants With Best Overall Response (OR) | Docetaxel + Prednisone + Placebo | Partial Response | 9 | Participants | |
| Number of Participants With Best Overall Response (OR) | Docetaxel + Prednisone + Intetumumab | Partial Response | 8 | Participants | |
| Number of Participants With Prostate Specific Antigen (PSA) Response | Docetaxel + Prednisone + Placebo | 43 | Participants | ||
| Number of Participants With Prostate Specific Antigen (PSA) Response | Docetaxel + Prednisone + Intetumumab | 27 | Participants | ||
| Overall Survival | Docetaxel + Prednisone + Placebo | 626.0 | 95% Confidence Interval 532.0 to NA | Days | |
| Overall Survival | Docetaxel + Prednisone + Intetumumab | 522.0 | 95% Confidence Interval 418.0 to NA | Days |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Docetaxel + Prednisone + Placebo | 65 | |
| Overall Study | STARTED | Docetaxel + Prednisone + Intetumumab | 66 | |
| Overall Study | COMPLETED | Docetaxel + Prednisone + Placebo | 9 | |
| Overall Study | COMPLETED | Docetaxel + Prednisone + Intetumumab | 4 | |
| Overall Study | NOT COMPLETED | Docetaxel + Prednisone + Placebo | 56 | |
| Overall Study | NOT COMPLETED | Docetaxel + Prednisone + Intetumumab | 62 |
Source ClinicalTrials.gov
Adverse events564
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 | Docetaxel + Prednisone + Placebo | 12 | 65 | |
| other | Anaemia | Blood and lymphatic system disorders | Docetaxel + Prednisone + Intetumumab | 9 | 66 | |
| other | Anaemia | Blood and lymphatic system disorders | Docetaxel + Prednisone + Placebo/ Intetumumab | 1 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab | 0 | 9 | |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel + Prednisone + Placebo | 22 | 65 | |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel + Prednisone + Intetumumab | 16 | 66 | |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel + Prednisone + Placebo/ Intetumumab | 0 | 2 | |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab | 1 | 9 | |
| other | Neutropenia | Blood and lymphatic system disorders | Docetaxel + Prednisone + Placebo | 21 | 65 | |
| other | Neutropenia | Blood and lymphatic system disorders | Docetaxel + Prednisone + Intetumumab | 14 | 66 |
1 to 10 of 564Source ClinicalTrials.gov
See all 564 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docetaxel + Prednisone + Placebo | ||
| Total, all-cause mortality | Docetaxel + Prednisone + Intetumumab | ||
| Total, all-cause mortality | Docetaxel + Prednisone + Placebo/ Intetumumab | ||
| Total, all-cause mortality | Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab | ||
| Total, other adverse events | Docetaxel + Prednisone + Placebo | 59 | 65 |
| Total, other adverse events | Docetaxel + Prednisone + Intetumumab | 59 | 66 |
| Total, other adverse events | Docetaxel + Prednisone + Placebo/ Intetumumab | 2 | 2 |
| Total, other adverse events | Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab | 6 | 9 |
| Total, serious adverse events | Docetaxel + Prednisone + Placebo | 23 | 65 |
| Total, serious adverse events | Docetaxel + Prednisone + Intetumumab | 24 | 66 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Docetaxel + Prednisone + Placebo vs Docetaxel + Prednisone + Intetumumab: Number of Participants With Prostate Specific Antigen (PSA) Response |
Source 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/NCT00537381
GET https://conductscience.org/api/trials/v1/NCT00537381/results?page=2