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NCT00884715 Clinical Trial

Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

Carcinoid Syndrome Clinical Trial

Official title:
Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00884715
Other study ID # IP107-002
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received April 20, 2009
Last updated September 17, 2013
Start date July 2009
Est. completion date December 2011

Study information
Verified date September 2013
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.

Description:

This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- histologically confirmed tumor

- documented evidence of carcinoid syndrome

- life expectancy of at least 6 months

- previous positive octreotide scan

- received stable doses of octreotide injections

- performance status of 0-2 on the ECOG performance scale

Exclusion Criteria:

- poorly differentiated or high grade neuroendocrine tumor

- significant cv, hepatic, renal or other disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Octreotide
short acting octreotide

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea 9 months No
Secondary safety and tolerability of the implants 9 months Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04993261 - An Investigational Scan (Dual Energy CT) in Detecting Gastrointestinal Carcinoid Tumors Early Phase 1
Not yet recruiting NCT04039516 - Carcinoid Heart Disease and Peptide Receptor Radiotargetted Therapy Phase 2
Completed NCT01234168 - A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea
Terminated NCT04073017 - Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency N/A
Recruiting NCT05756608 - Fibrosis in Chronic and Delayed Myocardial Infarction
Completed NCT00774930 - An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome Phase 3
Withdrawn NCT04713202 - Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl Phase 2
Completed NCT00853047 - Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy Phase 2
Completed NCT02063659 - Telotristat Etiprate for Carcinoid Syndrome Therapy Phase 3
Withdrawn NCT04776876 - Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome Phase 2
Completed NCT03223428 - Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
Recruiting NCT03453489 - AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm Phase 2
Active, not recruiting NCT05361668 - Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome Phase 2
Completed NCT01104415 - Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Phase 2
Withdrawn NCT01172717 - Study of Panitumumab in the Treatment of Carcinoid Syndrome Phase 2
Completed NCT01677910 - TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) Phase 3
Completed NCT01430871 - Effects of Serotonin Excess on Bone in Carcinoid Syndrome N/A
Completed NCT02026063 - Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms Phase 3
Terminated NCT01018953 - Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome Phase 2
Terminated NCT04140409 - Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation Phase 4

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