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

NCT00613691 | Completed Phase 1

• 1 other identifier: SPI-1620
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 for SPI-1620 is identified, a second phase of the study will focus on dose escalation of docetaxel studied in groups of 3-6 patients. This part of the study will assess the safety and tolerability of increasing doses of docetaxel administered with the optimal dose of SPI 1620 defined in Part I.

Conditions

Carcinoma

Keywords

Refractory; Progressive

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy.

  every three weeks

Secondary Outcomes (3)

• To assess the pharmacokinetic and pharmacodynamic profiles of SPI-1620 administered to patients with recurrent or progressive carcinoma who have failed all standard therapy.

  one week

• To identify the optimum dose of SPI-1620 to be used in future Phase II studies.

  every three weeks

• To assess the safety and tolerability of doses of docetaxel from 60 mg/m2 to 100 mg/m2 when given following infusion of SPI 1620.

  every three weeks

Study Arms (1)

SPI-1620

EXPERIMENTAL

SPI-1620 an endothelin B agonist

Drug: SPI-1620

Interventions

SPI-1620 DRUG

SPI-1620 in escalating doses from 0.5 μg/m2 intravenous over sixty seconds

SPI-1620

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (1)

START

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Carcinoma

Interventions

sovateltide

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Anthony Tolcher, MD

  START

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 21, 2013

Record last verified: 2013-10

Locations

US (1)