StomatitisPhase 2NCT00104065
Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant
A Phase 2 study testing CG53135-05, velafermin in people with Stomatitis, run by CuraGen Corporation at 9 sites in United States.
Trial summary
CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomatitis
- What is being tested?
- CG53135-05, velafermin
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Jan 2005to Dec 2005
- Phase
- Phase 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
- Male or female patients ages > 18 yrs
- Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens include at least one of the following: high dose melphalan (Mel 200), busulfan, or etoposide, with or without total body irradiation.
- Patients with Karnofsky performance scores > or = 70%
- Informed consent for participation in study
Who cannot join
- Patients who weigh < 33 kg
- Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
- Patients with active medical conditions that preclude autologous hematopoietic stem cell transplantation
- Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C
- Patients with known hypersensitivity to recombinant protein therapeutics
- Patients who have taken CG53135-05, palifermin or other investigational drugs in the past 30 days
Show all 9Show fewer
- Patients who have untreated symptomatic dental infection
- Patients with a history of sensitivity or allergy to E. coli-derived products
- Patients with WHO Grade 3 or 4 oral mucositis (OM)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Research Facility
Chicago, Illinois, 60611
Research Facility
Cleveland, Ohio, 44195
Research Facility
Denver, Colorado, 80218
Research Facility
La Jolla, California, 92037
Research Facility
Miami, Florida, 33136
Research Facility
New York, New York, 10021
Research Facility
Portland, Oregon, 97239
Research Facility
Winston-Salem, North Carolina, 27157
Research Facility
Worcester, Massachusetts, 01655
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of CG53135-05 Administered Intravenously as a Single Dose for the Prevention of Oral Mucositis in Patients Receiving Autologous Hematopoietic Stem Cell Transplant
CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy of CG53135-05 when administered as a single dose to patients at risk for developing oral mucositis.
- Conditions
- Stomatitis
- Being tested
- CG53135-05, velafermin
- Keywords
- oral mucositis, oncology - supportive care, mouth diseases
- Medical subject headings
- Stomatitis, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG53135-05, velaferminDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatitisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- CuraGen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104065
- Sponsor's protocol ID
- C-421
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2005
- Last updated
- 15 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of CG53135-05 Administered Intravenously as a Single Dose for the Prevention of Oral Mucositis in Patients Receiving Autologous Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00104065
- Acronym / sponsor ID
- C-421
- Conditions
- Stomatitis
- Keywords
- oral mucositis, oncology - supportive care, mouth diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- CuraGen CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 23 Feb 2005 (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.
CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy of CG53135-05 when administered as a single dose to patients at risk for developing oral mucositis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients ages > 18 yrs
- Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens include at least one of the following: high dose melphalan (Mel 200), busulfan, or etoposide, with or without total body irradiation.
- Patients with Karnofsky performance scores > or = 70%
- Informed consent for participation in study
Key exclusion criteria (9 listed)
- Patients who weigh < 33 kg
- Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
- Patients with active medical conditions that preclude autologous hematopoietic stem cell transplantation
- Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C
- Patients with known hypersensitivity to recombinant protein therapeutics
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 |
|---|---|---|
| CG53135-05, velafermin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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Stomatitis
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CG53135-05, velafermin in people with Stomatitis, run by CuraGen Corporation at 9 sites in United States.
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 9 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: finished, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 15 Mar 2016.