Extension Study of the Safety and Efficacy of Atiprimod Treatment in Neuroendocrine Carcinoma - Full Text View

Sponsored by:	Callisto Pharmaceuticals
Information provided by:	Callisto Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00663429

Purpose

This study is an extension study to the Callisto protocol CP-106. Subjects must have completed all 12 treatment cycles of CP-106 without disease progression as per RECIST criteria,to be eligible to to be enrolled in this study. This study will evaluate the safety and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s).

Condition	Intervention	Phase
Neuroendocrine Carcinoma	Drug: Atiprimod	Phase II

MedlinePlus related topics: Cancer Diarrhea

Drug Information available for: SK&F 106615

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Open-Label Extension Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma

Further study details as provided by Callisto Pharmaceuticals:

Primary Outcome Measures:

Reduction of symptoms (diarrhea, flushing and/or wheezing) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Progression of neuroendocrine tumor(s) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Oral, 14 days on / 14 days off; 30mg capsules

Detailed Description:

For carcinoid, despite the many cytotoxic chemotherapy trials that have been conducted, no regimen has demonstrated a response rate of more than 20% using the criterion of a 50% reduction of bidimensionally measurable disease. In the more recently reported ECOG phase III study of chemotherapy in carcinoid tumors (E1281), patients were randomly assigned to treatment with 5-fluorouracil (5FU) plus doxorubicin or 5FU plus streptozocin. The median progression free survival durations were disappointing. They were 4.5 months in the 5FU plus doxorubicin arm and 5.3 months in the 5FU plus streptozocin arm. Overall survival durations recorded in the trial were also suboptimal at 15 and 24 months respectively. There is no clear survival benefit for cytotoxic chemotherapy.

This is a phase II, multi-center, open-label extension study of the safety and efficacy of atiprimod treatment in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable local-regional cancer and who have either symptoms (diarrhea, flushing and/or wheezing) despite standard therapy (octreotide) or progression of neuroendocrine tumor(s) (defined as the appearance of one or more new lesions or a 20% increase in the sum of the longest diameter of target lesions during the 6 months prior to enrollment in CP-106). Atiprimod will be administered orally as a single daily dose of 60 mg/day for 14 days, followed by a 14-day treatment-free period (i.e., 1 treatment cycle = 28 days).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject was enrolled in Protocol No. CP-106 and successfully completed 12 treatment cycles.
Subject must have been classified as a responder at the time of completion of Protocol No. CP-106 [i.e., SD or better per RECIST Committee criteria or stable symptoms or better (defined as an average daily frequency of bowel movements, flushing episodes and/or wheezing episodes that is the same as or less than the average daily frequency of bowel movements, flushing episodes and/or wheezing episodes recorded during the 14-day screening period prior to enrollment in Protocol No. CP-106)].
Subject must understand and voluntarily sign the informed consent document.
Subject must have adequate organ function defined as follows: Absolute granulocyte count (AGC) >1,500/mm3, hemoglobin >8 g/dl, platelets >100,000/mm3, serum bilirubin <1.5 x upper limit of normal (ULN), serum creatinine <1.5 mg/dL, SGOT ≤Grade 1 per NCI CTCAE, SGPT ≤Grade 1 per NCI CTCAE.
Women of child bearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).

Exclusion Criteria:

Subject who was enrolled in Protocol No. CP-106 and who did not successfully complete 12 treatment cycles.
If WCBP, pregnant, lactating or not using adequate contraception.
Clinically relevant active infection or serious co-morbid medical conditions that are uncontrolled or whose control may be jeopardized by atiprimod treatment.
Psychiatric disorders rendering subjects incapable of complying with the requirements of the protocol.
Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
As atiprimod is a potent inhibitor of CYP2D6, the use of drugs that are substrates of CYP2D6 (e.g. beta blockers, antidepressants, and antipsychotic;) will not be allowed while on study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663429

Locations

United States, Arkansas
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029

Sponsors and Collaborators

Callisto Pharmaceuticals

Investigators

Study Director:

Gary S Jacob, PhD

Callisto Pharmaceuticals

More Information

No publications provided

Responsible Party:	Callisto Pharmaceuticals ( Gary S. Jacob, PhD Chief Executive Officer )
Study ID Numbers:	CP-AT202-07
Study First Received:	April 18, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00663429 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neuroectodermal Tumors
Carcinoma, Neuroendocrine
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Adenocarcinoma
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Adenocarcinoma
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009