Clinical trial · Interventional
Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors
A Phase I Intensive Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors Who Receive Radiation Therapy
NCT02209701CI-TRIAL-00015333terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Porfiromycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Porfiromycin
- interventionNames
- Drug: Porfiromycin
Primary outcomes (2)
- measure
- Assessment of serum concentrations of the analyte
- timeFrame
- up to 6 hours after drug infusion
- measure
- Amount of analyte excreted in urine
- timeFrame
- 0-3 and 3-6 hours after infustion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.