Trial · NCT00781911
A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer
NCT00781911, Phase 2, Completed, Eli Lilly and Company; results first posted 2018-04-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer. Trials, record NCT00781911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00781911
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Cixutumumab (IMC-A12) in Islet Cell Cancer
- NCT number
- NCT00781911
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Carcinoma, Neuroendocrine Tumors
- Interventions
- Cixutumumab, depot octreotide
- First posted
- 2008-10-29
- Last updated
- 2019-09-20
- Results first posted
- 2018-04-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months | From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months) | Percentage of participants who are alive and progression-free at 6 month from start of the study treatment over all participants. PFS is defined as the time from the start of study treatment until the date of objectively determined progressive disease (PD) or death due to any cause. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation of progression or death will be censored at the date of last tumor assessment. The PFS was estimated by the binomial distribution and Kaplan-Meier method. |
| Secondary | Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR) | From Start of Treatment Baseline to Disease Progression (Up to 18 Months) | Modified ORR is defined as CR+ PR + MR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD and MR defined as 20% - 29% reduction. Disease progression defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. |
| Secondary | Percentage of Participants With a Biochemical Response Rate | From Start of Treatment Up to 18 Months | Determine the biochemical response rate (≥ 50% reduction in tumor-specific markers; may include, not limited to 24 hour urine 5-hydroxyindoleacetic acid, chromogranin A, adrenocorticotropin hormone (ACTH), or gastrin) in the subset of participants with biochemically measurable disease. |
| Secondary | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | 18 months | Number of participants that had at least one TEAE is presented. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | |
| Secondary | PK: Half-life (t 1/2) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | |
| Secondary | PK: Area Under Concentration (AUCinf) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | |
| Secondary | PK: Clearance (CL) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | |
| Secondary | PK: Volume at Steady State (Vss) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | |
| Secondary | Serum Anti-Cixutumumab Antibody Assessment | 18 months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months | From Start of Study Treatment to Progressive Disease or Death Due to Any Cause (Up to 6 Months) | All participants who received at least one dose of study drug. Participants censored in the carcinoid tumor arm were 8 and in the islet cell carcinoma arm were 4. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR) | From Start of Treatment Baseline to Disease Progression (Up to 18 Months) | All participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Biochemical Response Rate | From Start of Treatment Up to 18 Months | All participants who received at least one dose of study drug and had evaluable baseline and post-baseline Chromogranin A and Gastrin data. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | 18 months | All participants who had received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters. | ||
| SECONDARY | PK: Half-life (t 1/2) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters. | ||
| SECONDARY | PK: Area Under Concentration (AUCinf) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters. | ||
| SECONDARY | PK: Clearance (CL) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters. | ||
| SECONDARY | PK: Volume at Steady State (Vss) Cycle 1 | Prior to the final infusion, immediately after the infusion, and 1, 2, 4, 8, 48, 96, 168, and 336 hours after the completion of the final infusion | Zero participants were analyzed. The assay used to measure serum concentrations of cixutumumab was not fully developed and validated, and the resulting data was therefore not suitable for estimation of PK parameters. | ||
| SECONDARY | Serum Anti-Cixutumumab Antibody Assessment | 18 months | Zero participants were analyzed due to no data collection due to low number of clinical responses observed. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months | Carcinoid Tumor | Binomial Distribution; Primary Analysis | 45.2 | 95% Confidence Interval 27.3 to 64.0 | percentage of participants |
| Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months | Islet Cell Carcinoma | Binomial Distribution; Primary Analysis | 41.7 | 95% Confidence Interval 15.2 to 72.3 | percentage of participants |
| Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months | Carcinoid Tumor | Kaplan-Meier Method; Secondary Analysis | 54.1 | 95% Confidence Interval 34.2 to 70.3 | percentage of participants |
| Percentage of Participants With Progression-Free Survival (PFS) Rate at Six Months | Islet Cell Carcinoma | Kaplan-Meier Method; Secondary Analysis | 61.4 | 95% Confidence Interval 26.6 to 83.5 | percentage of participants |
| Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR) | Carcinoid Tumor | 3.2 | 95% Confidence Interval 0.1 to 16.7 | percentage of participants | |
| Percentage of Participants Who Achieve Modified Objective Response Rate (ORR) of Complete Response (CR), Partial Response (PR) and Minor Response (MR) Modified Objective Response Rate (mORR) | Islet Cell Carcinoma | 0 | 95% Confidence Interval 0 to 26.5 | percentage of participants | |
| Percentage of Participants With a Biochemical Response Rate | Carcinoid Tumor | Chromogranin A | 0.0 | 95% Confidence Interval 0.0 to 13.7 | percentage of participants |
| Percentage of Participants With a Biochemical Response Rate | Islet Cell Carcinoma | Chromogranin A | 22.2 | 95% Confidence Interval 2.8 to 60 | percentage of participants |
| Percentage of Participants With a Biochemical Response Rate | Carcinoid Tumor | Gastrin | 0.0 | 95% Confidence Interval 0.0 to 45.9 | percentage of participants |
| Percentage of Participants With a Biochemical Response Rate | Islet Cell Carcinoma | Gastrin | 0.0 | 95% Confidence Interval 0.0 to 84.2 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carcinoid Tumor | 31 | |
| Overall Study | STARTED | Islet Cell Carcinoma | 12 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Carcinoid Tumor | 31 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Islet Cell Carcinoma | 12 | |
| Overall Study | COMPLETED | Carcinoid Tumor | 25 | |
| Overall Study | COMPLETED | Islet Cell Carcinoma | 4 | |
| Overall Study | NOT COMPLETED | Carcinoid Tumor | 6 | |
| Overall Study | NOT COMPLETED | Islet Cell Carcinoma | 8 |
Source ClinicalTrials.gov
Adverse events300
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 | Carcinoid Tumor | 2 | 31 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Islet Cell Carcinoma | 1 | 12 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Carcinoid Tumor | 0 | 31 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Islet Cell Carcinoma | 1 | 12 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Carcinoid Tumor | 2 | 31 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Islet Cell Carcinoma | 2 | 12 | 3 |
| other | Deafness | Ear and labyrinth disorders | Carcinoid Tumor | 2 | 31 | 2 |
| other | Deafness | Ear and labyrinth disorders | Islet Cell Carcinoma | 2 | 12 | 2 |
| other | Ear discomfort | Ear and labyrinth disorders | Carcinoid Tumor | 1 | 31 | 1 |
| other | Ear discomfort | Ear and labyrinth disorders | Islet Cell Carcinoma | 1 | 12 | 1 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carcinoid Tumor | ||
| Total, all-cause mortality | Islet Cell Carcinoma | ||
| Total, other adverse events | Carcinoid Tumor | 31 | 31 |
| Total, other adverse events | Islet Cell Carcinoma | 12 | 12 |
| Total, serious adverse events | Carcinoid Tumor | 12 | 31 |
| Total, serious adverse events | Islet Cell Carcinoma | 6 | 12 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Carcinoid Tumor vs Islet Cell Carcinoma: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| Carcinoid Tumor vs Islet Cell Carcinoma: 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/NCT00781911
GET https://conductscience.org/api/trials/v1/NCT00781911/events?page=2