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NCT02795858

A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors

Completed Phase 2 Results posted Last updated 19 February 2025
What this trial tests

Phase 2 trial testing Ramucirumab in Carcinoid Tumors in 43 participants. Completed in 31 December 2023.

Timeline
14 June 2016
Primary endpoint
31 December 2022
31 December 2023

Quick facts

Lead sponsorDana-Farber Cancer Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment43
Start date14 June 2016
Primary completion31 December 2022
Estimated completion31 December 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Dana-Farber Cancer Institute

Who can join

18 and older, any sex, with Carcinoid Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-Free Survival (PFS) Primary · Survival collected every 12 weeks in long-term follow-up. The median survival follow-up time was 23.5 months (range 1.7 - 76.6 months)

To assess the progression-free survival duration of patients with advanced, progressive carcinoid tumors treated with ramucirumab in combination with somatostatin analog therapy. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression. Partial Response (PR) is defined as at least a 30%

GroupValue95% CI
Ramucirumab + Somatostatin Analog14.29.0 – 25.6
Overall Survival Secondary · The median survival follow-up time was 23.5 months (range 1.7 - 76.6 months)

To assess the overall survival duration of patients with advanced carcinoid tumors treated with ramucirumab. We will use the Kaplan-Meier method to estimate the distribution of overall survival.

GroupValue95% CI
Ramucirumab + Somatostatin Analog24.920.7 – 43.1
Overall Radiographic Response Secondary · 2 years

To evaluate disease response using RECIST criteria, version 1.1, of patients with advanced carcinoid tumors treated with Ramucirumab. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT include the following categories of disease response: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable disease (SD), less than 30% decrease but no more than 20% increase in sum of the longest diameter of target lesions. We will estimate th

Partial Response
GroupValue95% CI
Ramucirumab + Somatostatin Analog2
Stable Disease
GroupValue95% CI
Ramucirumab + Somatostatin Analog33
Progressive Disease
GroupValue95% CI
Ramucirumab + Somatostatin Analog3
Not Restaged
GroupValue95% CI
Ramucirumab + Somatostatin Analog5
Biochemical Response (Chromogranin A) Secondary · 2 years

To evaluate biochemical response in patients with elevated chromogranin A at baseline, using levels of chromogranin-A measured at baseline and following treatment with Ramucirumab. Biochemical response was defined as greater than 50% drop in chromogranin A from baseline. During the screening period, all patients were evaluated for serum chromogranin A. Per protocol, if results of these are normal at baseline, they were not repeated while on study. If above institutional ULN at baseline, they were evaluated at time of tumor restaging.

GroupValue95% CI
Ramucirumab + Somatostatin Analog4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events evaluated on treatment on day 1 and 15 of each cycle and follow-up for 30 days off treatment. Observation period with median of 194 days and range (30-1416 days). All-Cause Mortality monitored/assessed up to 76.6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ramucirumab In Combination With Somatostatin Analog
Serious: 15/43 (35%)
Deaths: 33/43

Serious adverse events (23 terms)

ReactionSystemRamucirumab In Combination…
PneumoniaInfections and infestations
PainGeneral disorders
Abdominal painGastrointestinal disorders
Acute kidney injuryRenal and urinary disorders
AscitesGastrointestinal disorders
Cardiac chest painCardiac disorders
Clostridium difficile infectionInfections and infestations
Colonic obstructionGastrointestinal disorders
ConfusionPsychiatric disorders
DehydrationMetabolism and nutrition disorders
DizzinessNervous system disorders
DyspneaRespiratory, thoracic and mediastinal disorders
FallInjury, poisoning and procedural complications
FeverGeneral disorders
Intraventricular conductionCardiac disorders
Lower extremity edemaGeneral disorders
ObstipationGastrointestinal disorders
Pharyngeal dysphagiaGastrointestinal disorders
Pleural effusionRespiratory, thoracic and mediastinal disorders
SepsisInfections and infestations
Small bowel obstructionGeneral disorders
SyncopeNervous system disorders
Urinary tract infectionInfections and infestations
Other adverse events (67 terms — click to expand)

ReactionSystemRamucirumab In Combination…
FatigueGeneral disorders
HypertensionVascular disorders
Aspartate aminotransferase increasedInvestigations
ProteinuriaRenal and urinary disorders
DiarrheaGastrointestinal disorders
Edema limbsGeneral disorders
HyperglycemiaMetabolism and nutrition disorders
Abdominal painGastrointestinal disorders
Platelet count decreasedInvestigations
Alkaline phosphatase increasedInvestigations
HeadacheNervous system disorders
HypoalbuminemiaMetabolism and nutrition disorders
NauseaGastrointestinal disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Creatinine increasedInvestigations
DyspneaRespiratory, thoracic and mediastinal disorders
Alanine aminotransferase increasedInvestigations
AnorexiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
AnemiaBlood and lymphatic system disorders
CoughRespiratory, thoracic and mediastinal disorders
DehydrationMetabolism and nutrition disorders
DizzinessNervous system disorders
HematuriaRenal and urinary disorders
HypercalcemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
HypocalcemiaMetabolism and nutrition disorders
HypomagnesemiaMetabolism and nutrition disorders
VomitingGastrointestinal disorders
White blood cell decreasedInvestigations
Neutrophil count decreasedInvestigations
HypokalemiaMetabolism and nutrition disorders
PainGeneral disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Weight lossInvestigations
ConstipationGastrointestinal disorders
FlushingVascular disorders
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
HypoglycemiaMetabolism and nutrition disorders
MyalgiaMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Pneumonia, Pain, Abdominal pain, Acute kidney injury, Ascites, Cardiac chest pain, Clostridium difficile infection, Colonic obstruction.

Data from ClinicalTrials.gov NCT02795858 adverse events section.

Sponsor's own description

This research study is evaluating the drug Ramucirumab as a possible treatment for Advanced, Progressive Carcinoid Tumors.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Systemic treatment for lung carcinoids: from bench to bedside.
    Torniai M, Scortichini L, Tronconi F, Rubini C, et al · · 2019 · cited 19× · PMID 31273555 · DOI 10.1186/s40169-019-0238-5
  2. Medical Management of Gastroenteropancreatic Neuroendocrine Tumors.
    Chandrasekharan C. · · 2020 · cited 7× · PMID 32151362 · DOI 10.1016/j.soc.2019.11.004
  3. A phase II study of ramucirumab and somatostatin analog therapy in patients with advanced neuroendocrine tumors.
    Perez K, Kulke MH, Zheng H, Allen J, et al · · 2025 · cited 3× · PMID 39834129 · DOI 10.1093/oncolo/oyae364
  4. Pancreatic ductal adenocarcinoma: integrating molecular insights for targeted interventions.
    Nagaraju GP, Nellipudi H, Ganji C, Kuppala V, et al · · 2026 · PMID 42082461 · DOI 10.1038/s41392-026-02705-5
  5. Rethinking gastroenteropancreatic neuroendocrine neoplasms: A perspective on cellular origins, molecular mechanisms, and combination therapies.
    Shi H, Xu S, Lin R. · · 2026 · PMID 42058023 · DOI 10.1515/jtim-2026-0035

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