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

Boehringer Ingelheim

Status and phase: Terminated; Phase 1

Conditions: Head and Neck Neoplasms

Treatments: Drug: Porfiromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02209701

1164.3

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Porfiromycin

Experimental group

Treatment:

Drug: Porfiromycin