Study of Atiprimod Treatment for Patients With Advanced Cancer

This study has been terminated.
(Sponsor Withdrew)
Sponsor:
Collaborator:
Callisto Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00430014
First received: January 31, 2007
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

Primary Objectives:

The primary objectives of this study are to identify the maximum tolerated dose (MTD) and to evaluate the safety of atiprimod when given in doses starting at 60 mg/day and ranging to 360 mg/day, or the MTD, whichever is lower, in patients with advanced cancer.

Secondary Objectives:

The secondary objectives of this study are to measure the pharmacokinetics of atiprimod and to evaluate the efficacy of atiprimod treatment in patients with advanced cancer, and to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.


Condition Intervention Phase
Advanced Cancer
Drug: Atiprimod
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Atiprimod [ Time Frame: With each 28 day (4 week) cycle ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: March 2005
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atiprimod Drug: Atiprimod
Starting Dose of 60 mg/day orally for 14 days of 28 day cycle.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
  2. Patient must have an estimated life expectancy of at least 12 weeks.
  3. Patient must have measurable or evaluable disease.
  4. Patient has an ECOG (Zubrod) performance status of 0 to 2.
  5. Age >/= 13 years at the time of signing informed consent.
  6. All necessary screening evaluations for determining eligibility must be obtained within 14 days prior to the first dose of study drug except for measurement of disease extent, which can be obtained within 28 days prior to the first dose of study drug.
  7. Patient must be able to adhere to the study visit schedule and other protocol requirements.
  8. Patient must understand and voluntarily sign an informed consent document.
  9. Women of childbearing 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 device; barrier contraceptive with spermicide; or vasectomized partner).

Exclusion Criteria:

  1. Renal insufficiency (serum creatinine levels >/= 2 times the upper limit of normal).
  2. Concomitant radiotherapy, chemotherapy, or other investigational agents/therapies.
  3. Peripheral neuropathy of Grade 3 or greater assessed by a directed neurologic examination, including light touch, pinprick, proprioception, and deep tendon reflexes of the upper and lower extremities; and questioning for symptoms of paresthesia and numbness (FACT/GOG-Ntx: Appendix D).
  4. Patients with evidence of clinically significant mucosal or internal bleeding. (For example, a decrease in hemoglobin of greater than 1.5 gm will be considered clinically significant.)
  5. Patients with a platelet count < 50,000 cells/mm^3.
  6. Patients with an absolute neutrophil count (ANC) of < 1000 cells/mm^3.
  7. ALT/SGPT or AST/SGOT levels >/= 2 times the upper limit of normal (ULN) except in patients with documented hepatic metastases.
  8. Total bilirubin > 2 times the ULN.
  9. Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study. Such examples include infection requiring hospitalization and psychiatric health which would make compliance understanding difficult.
  10. Clinically relevant active infection or serious co-morbid medical conditions such as recent (</6 months) MI, unstable angina, difficult to control CHF, uncontrolled HTN, difficult to control cardiac arrhythmias, COPD or chronic restrictive pulmonary disease, and cirrhosis. Examples of uncontrolled HTN and difficult to control cardiac arrhythmias include situations in which patients still have the problem while on medication or patients who have required > two medication changes in the last 6 months in order to control the problem, or cardiac patients with a NYHA classification of > Class II.
  11. If WCBP, pregnant, lactating, or not using adequate contraception.
  12. As atiprimod is a potent inhibitor of CYP2D6 (a chemical that is produced naturally by the body that processes and eliminates certain types of chemicals), patients taking drugs that are substrates of CYP2D6 (e.g., beta blockers, antidepressants, and antipsychotics; see Appendix G) will be excluded from the study.
  13. Received any form of radiotherapy, chemotherapy, or other investigational agents/therapies within 30 days prior to the first dose of study drug.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430014

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Callisto Pharmaceuticals
Investigators
Principal Investigator: Razelle Kurzrock, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00430014     History of Changes
Other Study ID Numbers: 2004-0913
Study First Received: January 31, 2007
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Relapsed
Atiprimod
Guanylyl cyclase receptor antagonist

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014