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

Primary Purpose

Neuroendocrine Carcinoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Atiprimod

About this trial

This is an interventional treatment trial for Neuroendocrine Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hematology Oncology Services of Arkansas
Mount Sinai Medical Center

Outcomes

Primary Outcome Measures

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

Progression of neuroendocrine tumor(s)

Secondary Outcome Measures

Adverse Events

Full Information

NCT ID

NCT00663429

First Posted

April 18, 2008

Last Updated

August 30, 2011

Sponsor

Callisto Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00663429

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Callisto Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Atiprimod

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Title

Progression of neuroendocrine tumor(s)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Adverse Events

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary S Jacob, PhD

Organizational Affiliation

Callisto Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Hematology Oncology Services of Arkansas

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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