Study of Atiprimod Treatment for Patients With Advanced Cancer

NCT00430014 | Terminated Phase 1

• 1 other identifier: 2004-0913
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Cancer

Keywords

Advanced Cancer; Relapsed; Atiprimod; Guanylyl cyclase receptor antagonist

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Atiprimod

  With each 28 day (4 week) cycle

Study Arms (1)

Atiprimod

EXPERIMENTAL

Drug: Atiprimod

Interventions

Atiprimod DRUG

Starting Dose of 60 mg/day orally for 14 days of 28 day cycle.

Atiprimod

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available.
• Patient must have an estimated life expectancy of at least 12 weeks.
• Patient must have measurable or evaluable disease.
• Patient has an ECOG (Zubrod) performance status of 0 to 2.
• Age \>/= 13 years at the time of signing informed consent.
• 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.
• Patient must be able to adhere to the study visit schedule and other protocol requirements.
• Patient must understand and voluntarily sign an informed consent document.
• 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).

You may not qualify if:

• Renal insufficiency (serum creatinine levels \>/= 2 times the upper limit of normal).
• Concomitant radiotherapy, chemotherapy, or other investigational agents/therapies.
• 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).
• 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.)
• Patients with a platelet count \< 50,000 cells/mm\^3.
• Patients with an absolute neutrophil count (ANC) of \< 1000 cells/mm\^3.
• ALT/SGPT or AST/SGOT levels \>/= 2 times the upper limit of normal (ULN) except in patients with documented hepatic metastases.
• Total bilirubin \> 2 times the ULN.
• 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.
• 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.
• If WCBP, pregnant, lactating, or not using adequate contraception.
• 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.
• Received any form of radiotherapy, chemotherapy, or other investigational agents/therapies within 30 days prior to the first dose of study drug.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Callisto Pharmaceuticals: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Recurrence

Interventions

azaspirane

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Razelle Kurzrock, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 1, 2007
• Study Start: March 1, 2005
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 15, 2012

Record last verified: 2012-02

Locations

US (1)