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A Phase II Open-Label Extension Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Carcinoma

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Trial Information

A Phase II Open-Label Extension Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Low to Intermediate Grade Neuroendocrine Carcinoma


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).


Inclusion Criteria:



1. Subject was enrolled in Protocol No. CP-106 and successfully completed 12 treatment
cycles.

2. 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)].

3. Subject must understand and voluntarily sign the informed consent document.

4. 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.

5. 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:

1. Subject who was enrolled in Protocol No. CP-106 and who did not successfully complete
12 treatment cycles.

2. If WCBP, pregnant, lactating or not using adequate contraception.

3. Clinically relevant active infection or serious co-morbid medical conditions that are
uncontrolled or whose control may be jeopardized by atiprimod treatment.

4. Psychiatric disorders rendering subjects incapable of complying with the requirements
of the protocol.

5. Any condition which, in the opinion of the Investigator, places the subject at
unacceptable risk if he/she were to participate in the study.

6. 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Gary S Jacob, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Callisto Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CP-AT202-07

NCT ID:

NCT00663429

Start Date:

November 2007

Completion Date:

March 2010

Related Keywords:

  • Neuroendocrine Carcinoma
  • Carcinoma
  • Carcinoma, Neuroendocrine

Name

Location

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