Progression-Free Survival (PFS)
| Group | Value (months) |
|---|---|
| Ramucirumab + Somatostatin Analog | 14.2 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
A Phase II Study of Ramucirumab With Somatostatin Analog Therapy in Patients With Advanced, Progressive Carcinoid Tumors
NCT0279585814 Jun 2016 to 31 Dec 2023
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This research study is evaluating the drug Ramucirumab as a possible treatment for Advanced, Progressive Carcinoid Tumors.
Experimental
Ramucirumab In Combination With Somatostatin Analog
Patients will receive treatment with ramucirumab starting at a dose of 8 mg/kg intravenously every 14 days of a 28-day treatment cycle. Patients already receiving a somatostatin analog continued somatostatin analog therapy at their current dose. Patients not already receiving a somatostatin analog initiated treatment at an approved dose, according to institutional guidelines. Toxicity and adverse events will be examined in the first 10 patients who complete one cycle of therapy before expanding enrollment.
Outcomes the sponsor listed as primary.
Progression-Free Survival (PFS)
Time frame · 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% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Overall Survival
Time frame · 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.
Overall Radiographic Response
Time frame · 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 the response rate and provide the associated 95% confidence interval.
Biochemical Response (Chromogranin A)
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (months) |
|---|---|
| Ramucirumab + Somatostatin Analog | 14.2 |
| Group | Value (months) |
|---|---|
| Ramucirumab + Somatostatin Analog | 24.9 |
| Group | Value (Participants) |
|---|---|
| Ramucirumab + Somatostatin Analog | 2 |
| Group | Value (Participants) |
|---|---|
| Ramucirumab + Somatostatin Analog | 4 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Ramucirumab In Combination With Somatostatin AnalogPatients started treatment with ramucirumab at a dose of 8 mg/kg intravenously every 14 days of a 28-day treatment cycle. Patients already receiving a somatostatin analog continued somatostatin analog therapy at their current dose. Patients not already receiving a somatostatin analog initiated treatment at an approved dose, according to institutional guidelines. | 33 / 43 | 15 / 43 | 43 / 43 |
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