Trial · NCT00246012
A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma
NCT00246012, Phase 1, Phase 2, Completed, Centocor, Inc.; results first posted 2013-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma. Trials, record NCT00246012. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00246012
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma
- NCT number
- NCT00246012
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 144 participants, actual
- Lead sponsor
- Centocor, Inc.
- Conditions
- Melanoma
- Interventions
- Intetumumab, Dacarbazine, Placebo
- First posted
- 2005-10-31
- Last updated
- 2013-08-19
- Other registries' IDs
- eudract:2004-002130-18
- Results first posted
- 2013-08-19
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 | Up to 21 days post-first infusion from the last treated participant in Phase 1 | The DLT is defined as any Grade 3 or higher adverse event identified by the safety data monitoring committee as attributable to intetumumab except for hypersensitivity reactions, which are not considered DLTs unless there are 2 or more occurrences of greater than or equal to Grade 3 hypersensitivity reaction within a group. |
| Primary | Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The maximum observed analyte concentration in serum was reported. |
| Primary | Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
| Primary | Half-life of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half. |
| Primary | Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Primary | Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. |
| Primary | Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The R is obtained by dividing AUC at two different time points. |
| Primary | Progression-Free Survival (PFS) - Phase 2 | From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication | The PFS was defined as the time from the date of randomization to the date of initial documented progressive disease (PD), or the date of initial documented symptomatic deterioration, or the date of death, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as a reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions. |
| Secondary | Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2 | Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable) | The CR: complete disappearance of all measurable and non-measurable target lesions and PR: 50 percent (%) or more decrease in sum of the longest diameters of target lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure. The best response achieved among all the evaluated time points was reported. |
| Secondary | Percentage of Participants Who Achieved CR - Phase 2 | Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable) | The CR: complete disappearance of all measurable and non-measurable target lesions. The participants who achieved CR as the best response were reported. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 | Up to 21 days post-first infusion from the last treated participant in Phase 1 | Safety population included all the participants who received at least 1 (partial or complete) dose of intetumumab/placebo or dacarbazine. | Participants | NUMBER |
| PRIMARY | Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The Pharmacokinetics (PK)-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. | Microgram per milliliter (mcg/mL) | MEAN |
| PRIMARY | Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | mcg*day/mL | MEAN |
| PRIMARY | Half-life of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Days | MEAN |
| PRIMARY | Total Clearance (CL) of Intetumumab After Intravenous Administration - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | mL/day/kg | MEAN |
| PRIMARY | Volume of Distribution (Vz) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | mL/kg | MEAN |
| PRIMARY | Accumulation Ratio (R) of Intetumumab - Phase 1 (Part 1) | Pre-infusion, post-infusion at 2, 4, 8, 24 hour, Day 8, Day 15, post-last dose (3 weeks or 1 week) and 3 months post-last dose | The PK-evaluable population included all the participants who had at least 1 PK sample and who received at least 1 (partial or complete) dose of intetumumab. Serum concentration data was insufficient to robustly estimate the accumulation ratio. | ||
| PRIMARY | Progression-Free Survival (PFS) - Phase 2 | From the date of randomization to date of initial documented progressive disease or death, whichever occured first, as assessed upto 6 months after last dose of study medication | The Intent-to-treat (ITT) population included all the participants who were randomly assigned to treatment. | Days | MEDIAN |
| SECONDARY | Percentage of Participants Who Achieved a Best Overall Tumor Response as Complete Response (CR) or Partial Response (PR) - Phase 2 | Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable) | The response-evaluable population included all the participants who were evaluable for response. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved CR - Phase 2 | Screening, within 1 week of the end of Cycles 2, 4, 6, 8 (but prior to the next cycle dose), and follow-up (3 and 6 months post-last dose where applicable) | The response-evaluable population included all the participants who were evaluable for response. | Percentage of Participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group97
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 | Intetumumab 3 mg/kg [Phase 1 (Part 1)] | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 | Intetumumab 5 mg/kg [Phase 1 (Part 1)] | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 | Intetumumab 10 mg/kg [Phase 1 (Part 1)] | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 | Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) - Phase 1 | Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] | 0 | Participants | ||
| Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1) | Intetumumab 3 mg/kg [Phase 1 (Part 1)] | 94.44 | Standard Deviation 9.037 | Microgram per milliliter (mcg/mL) | |
| Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1) | Intetumumab 5 mg/kg [Phase 1 (Part 1)] | 199.45 | Standard Deviation 64.093 | Microgram per milliliter (mcg/mL) | |
| Maximum Observed Serum Concentration (Cmax) of Intetumumab - Phase 1 (Part 1) | Intetumumab 10 mg/kg [Phase 1 (Part 1)] | 306.86 | Standard Deviation 54.979 | Microgram per milliliter (mcg/mL) | |
| Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1) | Intetumumab 3 mg/kg [Phase 1 (Part 1)] | 257.55 | Standard Deviation NA | mcg*day/mL | |
| Area Under the Serum Concentration Versus Time Curve (AUC) of Intetumumab - Phase 1 (Part 1) | Intetumumab 5 mg/kg [Phase 1 (Part 1)] | 503.71 | Standard Deviation NA | mcg*day/mL |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intetumumab 3 mg/kg [Phase 1 (Part 1)] | 3 | |
| Overall Study | STARTED | Intetumumab 5 mg/kg [Phase 1 (Part 1)] | 3 | |
| Overall Study | STARTED | Intetumumab 10 mg/kg [Phase 1 (Part 1)] | 3 | |
| Overall Study | STARTED | Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] | 3 | |
| Overall Study | STARTED | Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] | 3 | |
| Overall Study | STARTED | Dacarbazine + Placebo [Phase 2] | 32 | |
| Overall Study | STARTED | Intetumumab 5 mg/kg [Phase 2] | 32 | |
| Overall Study | STARTED | Intetumumab 10 mg/kg [Phase 2] | 33 | |
| Overall Study | STARTED | Dacarbazine + Intetumumab 10 mg/kg [Phase 2] | 32 | |
| Overall Study | Treated | Intetumumab 3 mg/kg [Phase 1 (Part 1)] | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,179
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 | Intetumumab 3 mg/kg [Phase 1 (Part 1)] | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Intetumumab 5 mg/kg [Phase 1 (Part 1)] | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Intetumumab 10 mg/kg [Phase 1 (Part 1)] | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Dacarbazine + Placebo [Phase 2] | 6 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Intetumumab 5 mg/kg [Phase 2] | 1 | 31 | |
| other | Anaemia | Blood and lymphatic system disorders | Intetumumab 10 mg/kg [Phase 2] | 0 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | Dacarbazine + Intetumumab 10 mg/kg [Phase 2] | 7 | 32 | |
| other | Leukopenia | Blood and lymphatic system disorders | Intetumumab 3 mg/kg [Phase 1 (Part 1)] | 0 | 3 |
1 to 10 of 1,179Source ClinicalTrials.gov
See all 1,179 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intetumumab 3 mg/kg [Phase 1 (Part 1)] | ||
| Total, all-cause mortality | Intetumumab 5 mg/kg [Phase 1 (Part 1)] | ||
| Total, all-cause mortality | Intetumumab 10 mg/kg [Phase 1 (Part 1)] | ||
| Total, all-cause mortality | Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)] | ||
| Total, all-cause mortality | Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)] | ||
| Total, all-cause mortality | Dacarbazine + Placebo [Phase 2] | ||
| Total, all-cause mortality | Intetumumab 5 mg/kg [Phase 2] | ||
| Total, all-cause mortality | Intetumumab 10 mg/kg [Phase 2] | ||
| Total, all-cause mortality | Dacarbazine + Intetumumab 10 mg/kg [Phase 2] | ||
| Total, other adverse events | Intetumumab 3 mg/kg [Phase 1 (Part 1)] | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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 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/NCT00246012
GET https://conductscience.org/api/trials/v1/NCT00246012/registered?page=2