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Status:

COMPLETED

A Phase I, Open-label, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Endothelin B Agonist, SPI-1620, in Patients With Recurrent or Progressive Carcinoma

Lead Sponsor:

Spectrum Pharmaceuticals, Inc

Conditions:

Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Once the MTD fo...

Detailed Description

This is a 2-part, open-label, single-arm, dose escalation study. Part I will define the Maximum Tolerated Dose (MTD) and optimal dose of SPI-1620 and evaluate its PK and PD properties. Eligible patien...

Eligibility Criteria

Inclusion

  • All of the following inclusion criteria must be met prior to participation in this study
  • The patient must sign an informed consent. A signed consent form is required prior to the performance of any protocol-related procedures or assessments.
  • The patient must be \>= 18 years of age.
  • The patient must have progressive or recurrent carcinoma and has failed all standard therapies for his/her tumor.
  • The patient must have a negative CT scan with contrast of the brain or MRI of the brain within 45 days of enrollment.
  • The patient must be using an acceptable/effective method of contraception if she is a female patient of childbearing potential.
  • The patient must have a negative serum pregnancy test within 14 days of entering the protocol if she is a female of childbearing potential.
  • The patient must have an ECOG score \<= 2.
  • The patient must be willing and able to abide by the protocol.

Exclusion

  • None of the exclusion criteria may be met prior to patient participation in this study
  • The patient has a history of CHF, migraines, coagulopathy, stroke or inadequately controlled hypertension.
  • The patient has asthma or symptomatic COPD.
  • The patient has autonomic nerve dysregulation syndrome.
  • The patient has angina or is taking nitrates or has had a MI within the past six months.
  • The patient has a significant ventricular arrhythmia, class III or IV CHF or has a known coronary stenoses \>80% and has not undergone either angioplasty or CABG
  • The patient is taking phosphodiesterase inhibitors
  • The patient has malignant or poorly controlled hypertension (\>160/100)
  • The patient has symptomatic orthostatic hypotension
  • The patient is taking arterial vasodilators such as nifedipine or amlodipine or alpha blockers such as terazosin, tamsulosin and prazosin.
  • The patient has a screening absolute neutrophil count less than 1.5 K/uL
  • The patient has a screening platelet count less than 100 K/uL.
  • The patient has a screening creatinine greater than 2.0 mg/dL
  • The patient has a screening amino alanine transferase (ALT), or aspartate aminotransferase (AST) \> 2.5 times the upper limit of the laboratory reference range or a total bilirubin \> 1.0 mg/dL.
  • The patient has a known immunodeficiency disorder.
  • The patient is enrolled, or the patient plans to enroll, in any concurrent study of another investigational product.
  • The patient is taking, or the patient is planning to take other cancer treatments during the study except for patients with prostate cancer using LHRH agonist therapy.
  • The patient has a known hypersensitivity to any of the components of SPI 1620 or to docetaxel.
  • The patient has previously failed treatment with docetaxel for his/her tumor and a dose of SPI-1620 that has been shown to enhance tumor blood flow has not been identified.
  • The patient does not have a tumor that is at least 1cm. -

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2012

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT00613691

Start Date

January 1 2008

End Date

December 1 2012

Last Update

October 21 2013

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San Antonio, Texas, United States, 78229