Extension Study of the Safety and Efficacy of Atiprimod Treatment in Neuroendocrine Carcinoma

NCT00663429 | Completed Phase 2

• 1 other identifier: CP-AT202-07
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (2)

• Reduction of symptoms (diarrhea, flushing and/or wheezing)

  1 year

• Progression of neuroendocrine tumor(s)

  1 year

Secondary Outcomes (1)

• Adverse Events

  1 year

Interventions

Atiprimod DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Callisto Pharmaceuticals: lead

Study Sites (2)

Hematology Oncology Services of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

azaspirane

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Gary S Jacob, PhD

  Callisto Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: November 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 31, 2011

Record last verified: 2009-01

Locations

US (2)