Trial · NCT01024387
AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
NCT01024387, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2017-12-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors. Trials, record NCT01024387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01024387
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
- NCT number
- NCT01024387
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Neuroendocrine Tumor, Carcinoid Tumor, Pancreatic Neuroendocrine Tumor
- Interventions
- AMG 479
- First posted
- 2009-12-02
- Last updated
- 2018-03-08
- Results first posted
- 2017-12-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks). | Objective response rate is the percentage of patients achieving partial response (PR) or complete response (CR) per RECIST 1.0 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status must be confirmed by repeat assessments performed no fewer than 4 weeks or more than 6 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Duration of Response | Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks). | The duration of response is measured from the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). |
| Secondary | Grade 3-4 Toxicity Rate | Toxicity was evaluated every cycle (3 weeks) on treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks). | Grade 3-4 toxicity rate is the percentage of patients who experienced a grade 3 or 4 adverse event with treatment attribution of possible, probable or definite based on CTCAEv4. |
| Secondary | Progression Free Survival | Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort were followed up to 20 months. | Progression-free survival (PFS) based on the Kaplan-Meier method is defined as the time from the start of treatment to the date of the first documented disease progression or death due to any cause. Patients without an event were censored at the earliest date of last disease assessment or initiation of non-protocol anti-cancer therapy. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. |
| Secondary | 1-Year Overall Survival | Patients in this study cohort were followed up to 20 months. | Overall survival (OS) based on the Kaplan-Meier method is defined as the time from treatment start to the date of death or censored at the date last known alive. 1-year overall survival is the probability (%) of remaining alive 1 year from the start of treatment. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks). | The analysis dataset is comprised of all response evaluable patients. | percentage of patients | NUMBER |
| SECONDARY | Duration of Response | Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks). | This endpoint was not evaluated because zero patients achieved objected response per RECIST criteria. | ||
| SECONDARY | Grade 3-4 Toxicity Rate | Toxicity was evaluated every cycle (3 weeks) on treatment. Patients in this study cohort received a median of 6 treatment cycles (18 weeks). | The analysis dataset is comprised of all enrolled patients. | percentage of patients | NUMBER |
| SECONDARY | Progression Free Survival | Disease was evaluated radiologically at baseline, every 3 cycles (9 weeks) on treatment and at end of treatment. Patients in this study cohort were followed up to 20 months. | The analysis dataset is comprised of all PFS evaluable patients. | months | MEDIAN |
| SECONDARY | 1-Year Overall Survival | Patients in this study cohort were followed up to 20 months. | The analysis dataset is comprised of all enrolled patients. | percent probability | 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 |
|---|---|---|---|---|---|
| Objective Response Rate | AMG 479 | 0.0 | percentage of patients | ||
| Grade 3-4 Toxicity Rate | AMG 479 | 31.7 | 95% Confidence Interval 22.3 to 45.0 | percentage of patients | |
| Progression Free Survival | AMG 479 | 6.3 | 95% Confidence Interval 4.2 to 12.6 | months | |
| 1-Year Overall Survival | AMG 479 | 66 | 95% Confidence Interval 52 to 77 | percent probability |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AMG 479 | 60 | |
| Overall Study | Evaluable for PFS | AMG 479 | 54 | |
| Overall Study | Evaluable for Response | AMG 479 | 53 | |
| Overall Study | COMPLETED | AMG 479 | 0 | |
| Overall Study | NOT COMPLETED | AMG 479 | 60 |
Source ClinicalTrials.gov
Adverse events189
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 | Anemia | Blood and lymphatic system disorders | AMG 479 | 21 | 60 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | AMG 479 | 1 | 60 | |
| other | Leukocytosis | Blood and lymphatic system disorders | AMG 479 | 1 | 60 | |
| other | Spleen disorder | Blood and lymphatic system disorders | AMG 479 | 1 | 60 | |
| other | Atrial flutter | Cardiac disorders | AMG 479 | 1 | 60 | |
| other | Chest pain - cardiac | Cardiac disorders | AMG 479 | 1 | 60 | |
| other | Palpitations | Cardiac disorders | AMG 479 | 4 | 60 | |
| other | Hearing impaired | Ear and labyrinth disorders | AMG 479 | 1 | 60 | |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | AMG 479 | 1 | 60 | |
| other | Cushingoid | Endocrine disorders | AMG 479 | 1 | 60 |
1 to 10 of 189Source ClinicalTrials.gov
See all 189 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AMG 479 | ||
| Total, other adverse events | AMG 479 | 57 | 60 |
| Total, serious adverse events | AMG 479 | 19 | 60 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23572164 | 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 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/NCT01024387
GET https://conductscience.org/api/trials/v1/NCT01024387/events?page=2