Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors

NCT02209701 | Terminated Phase 1

• 1 other identifier: 1164.3
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin and major metabolites in head and neck cancer and other cancer patients with solid tumors who receive radiation therapy.

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (2)

• Assessment of serum concentrations of the analyte

  up to 6 hours after drug infusion

• Amount of analyte excreted in urine

  0-3 and 3-6 hours after infustion

Study Arms (1)

Porfiromycin

EXPERIMENTAL

Drug: Porfiromycin

Interventions

Porfiromycin DRUG

Porfiromycin

Eligibility Criteria

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

You may qualify if:

• Patients with histologically proven advanced head and neck cancer or other solid tumors undergoing radiation therapy
• Patients with prior chemotherapy will be considered if chemotherapy occurred more than 30 days prior to this study
• Patients must be receiving concomitant radiotherapy (RT)
• Performance status of ≥ 70% on the Karnofsky performance scale (KPS)
• Must be ≥ 18 years of age
• Expected survival of at least three months
• Written informed consent

You may not qualify if:

• Patients who meet any of the following clinical laboratory criteria:
• Granulocyte count of \< 2000/mm\*\*3
• Platelets \< 75,000/mm\*\*3
• Serum creatinine \> 1.5 times the upper limit of normal
• Bilirubin \> 1.5 times the upper limit of normal
• Prothrombin time and partial thromboplastin time \> 1.5 times the upper limit of normal
• Women who are pregnant
• Men and women of child-bearing potential who are unwilling to utilize a medically acceptable method of contraception
• Patients who have any known bleeding disorder at the discretion of the investigator
• Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependent chronic obstructive pulmonary disease, or unstable liver or renal disease
• Treatment with granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor or Interleukin-1l within 30 days prior to the start of RT
• Patients who have had prior exposure to mitomycin C or porfiromycin

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Porfiromycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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: August 5, 2014
• First Posted: August 6, 2014
• Study Start: December 1, 1999
• Primary Completion: July 1, 2000
• Last Updated: August 6, 2014

Record last verified: 2014-08