Your session is about to expire
← Back to Search
Somatostatin Analog
P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
Phase 2
Waitlist Available
Led By Jonathan Strosberg, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
The primary purpose of the study is to investigate the effects of high-dose octreotide on flushing, diarrhea, and quality of life in patients whose disease-related symptoms are inadequately controlled by the maximum approved dose of octreotide LAR.
Eligible Conditions
- Neuroendocrine Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Improved Frequency of Diarrhea
Secondary study objectives
Rate of Progression Free Survival (PFS) at 6 Months
Side effects data
From 2012 Phase 4 trial • 29 Patients • NCT001083558%
GI Bleeding
8%
Hepatic encephalopathy
8%
Scrotal edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Albumin (Control Group)
Vasoconstrictor (Treatment Group)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Octreotide Long-acting Release (LAR)Experimental Treatment1 Intervention
Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Octreotide
FDA approved
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
564 Previous Clinical Trials
144,798 Total Patients Enrolled
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,301 Total Patients Enrolled
Jonathan Strosberg, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
7 Previous Clinical Trials
207 Total Patients Enrolled