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Efficacy and Safety of Oral Octreolin™ in Patients With Acromegaly Who Are Currently Receiving Parenteral Somatostatin Analogs


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Acromegaly

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Trial Information

Efficacy and Safety of Oral Octreolin™ in Patients With Acromegaly Who Are Currently Receiving Parenteral Somatostatin Analogs


Qualifying patients with acromegaly will receive treatment with Octreolin. Dose escalation
will proceed to identify the optimal dose for each patient. The optimal dose will be
continued as chronic therapy. Levels of GH and IGF-1 will be assessed during the study and
at end of treatment.


Inclusion Criteria:



- Adult subjects, aged 18 to 75 years old, inclusive

- Subjects with acromegaly defined as documented evidence of GH-secreting pituitary
tumor that is abnormally responsive to glucose who are currently receiving a
somatostatin analog

- Subjects able and willing to comply with the requirements of the protocol

- Subjects able to swallow capsules

- Subjects able to understand and sign written informed consent to participate in the
study

Exclusion Criteria:

- Symptomatic cholelithiasis

- Received pituitary radiotherapy within ten years prior to screening

- Undergone pituitary surgery within the prior 6 months

- Clinically significant GI, renal or hepatic disease

- Known allergy or hypersensitivity to any of the test compounds or materials

- Life expectancy of less than 2 years

- Uncontrolled diabetes

- Defects in visual fields due to optic chiasmal compression

- Female patients who are pregnant or lactating

- Female patients who are of childbearing potential

- History of immunocompromise, including a positive HIV test result (ELISA and Western
blot)

- History of alcohol or drug abuse

- Intake of an investigational drug within 30 days before patient inclusion in this
study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

IGF-1 concentration

Outcome Description:

Efficacy will be assessed at the end of 7 months of study drug treatment. Age-normalized IGF-1 concentration is the treatment goal.

Outcome Time Frame:

Completion of the treatment period

Safety Issue:

No

Principal Investigator

Shlomo Melmed, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CH-ACM-01

NCT ID:

NCT01412424

Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

  • Acromegaly
  • acromegaly
  • IGF-1
  • growth hormone
  • Octreolin
  • octreotide
  • somatostatin analog
  • Acromegaly

Name

Location

Cedars-Sinai Medical CenterLos Angeles, California  90048