Head and Neck NeoplasmsPhase 1NCT02209701
Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors
A Phase 1 study testing Porfiromycin in people with Head and Neck Neoplasms, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Porfiromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Dec 1999to Jul 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: A Phase I Intensive Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors Who Receive Radiation Therapy
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
- Being tested
- Porfiromycin
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PorfiromycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Porfiromycin | Experimental | Not described Receives: Drug: Porfiromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of serum concentrations of the analyte
Measured: up to 6 hours after drug infusion
Amount of analyte excreted in urine
Measured: 0-3 and 3-6 hours after infustion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startDec 1999
- Primary completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209701
- Sponsor's protocol ID
- 1164.3
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Intensive Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors Who Receive Radiation Therapy
- ClinicalTrials.gov ID
- NCT02209701
- Acronym / sponsor ID
- 1164.3
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 1999
- Primary completion
- Jul 2000 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Porfiromycin | Experimental | Drug: Porfiromycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Patients who meet any of the following clinical laboratory criteria:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Porfiromycin | Drug | Porfiromycin |
Primary outcome
Assessment of serum concentrations of the analyte
Time frame: up to 6 hours after drug infusion
Amount of analyte excreted in urine
Time frame: 0-3 and 3-6 hours after infustion
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Porfiromycin in people with Head and Neck Neoplasms, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of serum concentrations of the analyte (time frame: up to 6 hours after drug infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.