Head and Neck CancerPhase 1/2NCT00540332
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
A Phase 1/2 study testing palifermin in people with Head and Neck Cancer, run by Swedish Orphan Biovitrum.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- palifermin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Sep 2008
- Phase
- Phase 1/2
- 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
- History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1)
- Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg
Who cannot join
- Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins
- Metastatic disease (M1)
- Presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years
- History of pancreatitis
- Prior radiotherapy to the site of disease
- Prior chemotherapy or requiring chemotherapy during treatment phase of study
- Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors
About this study
Official title: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy
The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.
- Conditions
- Head and Neck Cancer
- Being tested
- Placebo, palifermin
- Keywords
- Oncology, KGF, HNC, head and neck, oral mucositis, OM, proteinurea, palifermin, clinical trial
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.
paliferminDrug
120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows:
* PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects
* Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects. Receives: Drug: Placebo |
| Palifermin | Experimental | Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows:
* PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects
* Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects. Receives: Drug: palifermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent proteinuria
Measured: 11 weeks
Duration of treatment-emergent proteinuria
Measured: 11 weeks
Incidence of chronic proteinuria
Measured: 11 weeks
Time (days) to onset of treatment-emergent proteinuria
Measured: 11 weeks
Maximum protein-to-creatinine ratio values during the treatment period
Measured: 11 weeks
Pharmacokinetic profile to include Systemic clearance, volume of distribution at steady state, estimated initial concentration, area under the conc-time curve, terminal half-life and mean residual time
Measured: in Week 1
Secondary outcomes (9)
Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4
Measured: 11 weeks
Disease status at End of Treatment visit
Measured: 11 weeks
Incidence of serum anti-palifermin antibody formation
Measured: 11 weeks
Incidence of second primary tumors
Measured: up to 10 years (Long-Term Follow-Up phase)
Incidence of other malignancies
Measured: up to 10 years (Long-Term Follow-Up phase)
Progression-free survival
Measured: up to 10 years (Long-Term Follow-Up phase)
Overall survival
Measured: up to 10 years (Long-Term Follow-Up phase)
Incidence of adverse events and laboratory abnormalities
Measured: 11 weeks
Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionSep 2008 (estimated)
Why it stopped: The 20070201 study was terminated based on evaluation of Palifermin solid tumor data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amgen
- Investigators
- MD, Study director, Biovitrum AB (publ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540332
- Sponsor's protocol ID
- 20070201
- Status last verified
- Jan 2009
- First submitted
- 4 Oct 2007
- Last updated
- 2 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy
- ClinicalTrials.gov ID
- NCT00540332
- Acronym / sponsor ID
- 20070201
- Conditions
- Head and Neck Cancer
- Keywords
- Oncology, KGF, HNC, head and neck, oral mucositis, OM, proteinurea, palifermin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The 20070201 study was terminated based on evaluation of Palifermin solid tumor data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- Amgen
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (estimated)
- First posted
- 8 Oct 2007 (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.
The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboApproximately 17 subjects to receive palifermin. Subjects will be enrolled as follows: * PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects * Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects. |
| Palifermin | Experimental | Drug: paliferminApproximately 23 subjects to receive palifermin. Subjects will be enrolled as follows: * PK cohort will be randomized in a 3:1 ratio [palifermin: placebo] in at least 12 subjects * Non-PK cohort will be randomized in a 1:1 ratio [palifermin: placebo] in up to 28 subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1)
- Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg
Key exclusion criteria (7 listed)
- Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins
- Metastatic disease (M1)
- Presence or history of any other primary malignancy, other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years
- History of pancreatitis
- Prior radiotherapy to the site of 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 |
|---|---|---|
| PlaceboSingle IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course. | Drug | Placebo |
| palifermin120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course | Drug | Palifermin |
Primary outcome
Incidence of treatment-emergent proteinuria
Time frame: 11 weeks
Duration of treatment-emergent proteinuria
Time frame: 11 weeks
Incidence of chronic proteinuria
Time frame: 11 weeks
Time (days) to onset of treatment-emergent proteinuria
Time frame: 11 weeks
Maximum protein-to-creatinine ratio values during the treatment period
Time frame: 11 weeks
Pharmacokinetic profile to include Systemic clearance, volume of distribution at steady state, estimated initial concentration, area under the conc-time curve, terminal half-life and mean residual time
Time frame: in Week 1
9 secondary outcomes
Time (days) to onset of severe Oral Mucositis WHO grade 3 or 4
Time frame: 11 weeks
Disease status at End of Treatment visit
Time frame: 11 weeks
Incidence of serum anti-palifermin antibody formation
Time frame: 11 weeks
Incidence of second primary tumors
Time frame: up to 10 years (Long-Term Follow-Up phase)
Incidence of other malignancies
Time frame: up to 10 years (Long-Term Follow-Up phase)
Progression-free survival
Time frame: up to 10 years (Long-Term Follow-Up phase)
Overall survival
Time frame: up to 10 years (Long-Term Follow-Up phase)
Incidence of adverse events and laboratory abnormalities
Time frame: 11 weeks
Incidence (%) and duration (days) of severe Oral Mucositis WHO grade 3 or 4
Time frame: 11 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2009.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Biovitrum AB (publ)
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing palifermin in people with Head and Neck Cancer, run by Swedish Orphan Biovitrum.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 2 Mar 2009. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Incidence of treatment-emergent proteinuria (time frame: 11 weeks). The study lists 6 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 2 Mar 2009.