Eye Diseases

All Conditions

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Mouth and Tooth Diseases

Digestive System Diseases

Rare Diseases

Cataract

Multiple Myeloma

Neoplasms, Plasma Cell

Stomatitis

Mucositis

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Melphalan

Subjects received palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)

Subjects received matched placebo before- and after-high dose chemotherapy

Subjects received palifermin before- and after-high dose chemotherapy (total of 6 doses)

One bolus IV injection at 60 μg/kg/day, on Days 6, 5 \& 4 days before-high dose chemotherapy and one bolus IV injection at 60 μg/kg/day of matched placebo on days 0, 1 \& 2 days after-high dose chemotherapy. Minimum of 4 days between before-chemotherapy and after-transplantation dosing.

Palifermin before only

One bolus IV injection at 60 μg/kg/day of matched placebo on Days 6, 5 \& 4 (before-high dose chemotherapy) and on Days 0, 1 \& 2 (after-high dose chemotherapy).

Minimum of 4 days between pre-chemotherapy and post-transplantation dosing.

Placebo

One bolus IV injection at 60 μg/kg/day, on Days 6, 5 \& 4 (before-high dose chemotherapy) and on Days 0, 1 \& 2 (after-high dose chemotherapy).

Minimum of 4 days between before-chemotherapy and after-transplantation dosing.

Palifermin before and after

Kristina Timdahl, MD

Dietger Niederwieser, Professor

The purpose of this study was to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologous peripheral blood stem cell transplantation. Amendment 01 (April 07) introduced three cataract assessments to be carried out at Screening, Month 6 and Month 12 in response to FDA and EMEA follow up measures.

This was a double-blind, placebo-controlled, randomized, multicenter Phase IIIb study of palifermin given before and after dose chemotherapy (total 6 doses) or before dose chemotherapy only (total 3 doses), in subjects with Multiple Myeloma (MM)receiving high dose melphalan (chemotherapy), in a 1-day schedule, followed by autologous Peripheral Blood Stem Cell Transplantation (PBSCT).

All subjects were to be followed for disease progression, second primary tumors, additional malignancies and survival for up to 10 years.

Planned: 275 subjects, in fact, 281 subjects were randomized. Randomized: 115 subjects to palifermin pre/post-CT, 109 subjects to palifermin pre-CT and 57 subjects to placebo Analyzed: 281 subjects in the full analysis set, 277 subjects in the safety subset.

Efficacy Oral cavity assessment, patient reported outcome (PRO) questionnaires (Oral Mucositis Daily Questionnaire \[OMDQ\], Functional Assessment of Cancer Therapy Esophageal \[FACT-E\], European Quality of Life Utility Scale \[EQ 5D\], Mucositis Chronic Symptoms Questionnaire \[MCSQ\]).

Safety Physical examination (including body temperature), concomitant medications, transfusions, vital signs, laboratory assessments (hematology, chemistry), cataract assessments, adverse events (AEs).

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma

A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin for Reduction in Severity of Oral Mucositis in Subjects With Multiple Myeloma Receiving Melphalan Followed by Autologous Blood Stem Cell Transplantation

For the primary efficacy endpoint maximum severity of Oral Mucositis (OM) was assessed, the number of participants who had the different severity. To assess severity of OM, a 5-grade WHO scale (0, 1, 2, 3, or 4) was used.

0 = no findings or erythema only, 1= soreness present with or without erythema, 2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally.

Number of participants from the primary cataract subset showing an increase from baseline of \>= 0.3 in the Lens Opacities Classification System III (LOCS III score). The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist trained in LOCS III uses a slit lamp for examining the lens of the eye. The classification evaluates four features: posterior subcapsular cataract(P),cortical cataract(C),nuclear opalescence(NO) and nuclear color(NC). NO and NC are graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each. In the current study, cataract development or progression was defined as an increase from baseline of ≥ 0.3 on any of the three features P, C or NO (NC is of less importance and has not been analysed further in this study).

The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:

2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally.

The duration of ulcerative mucositis measured the number of days the participants had different WHO grades 2, 3, and 4:

2=ulcers present but able to take solid food, 3 =ulcers present and only able to take liquids, 4 =ulcers present/not able to take anything orally. Patients that did not have any ulcerative mucositis were given a value of 0 days.

The mean daily scores were calculated using the subject daily assessment of Patient-reported mouth and throat soreness (MTS) on the 5 point scale with higher values in MTS indicating a worse self assessed MTS. A 5-grade WHO scale (0, 1, 2, 3, or 4). 0=no findings or erythema only, 1=soreness present with or without erythema, 2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The incidence of ulcerative mucositis WHO grades 2, 3, and 4. Measured the number of participants who had WHO grades 2, 3, and 4:

2=ulcers present but able to take solid food, 3=ulcers present and only able to take liquids, 4=ulcers present/not able to take anything orally. The area under the curve were calculated at the time points; Day(D)-2, up to Day 32.

To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior (P), Cortical Cataract (C) and Nuclear Opalescence (NO).

For Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO): at month 6 and 12 adjusted difference of rate of cataract, Palifermin - Placebo were used and the confidence interval were calculated on the adjusted difference.

To study the change in cataract from baseline visit to months 6, three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale.

To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in theLOCS III score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).

The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each.

To study the change in cataract from baseline visit to months 12, regarding the three cataract main types: nuclear, cortical and posterior subcapsular measured on the Lens Opacities Classification System III (LOCS III) Scale. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).

The LOCS III is a standard system used for grading and comparison of cataract severity and type. The ophthalmologist uses a slit lamp for examining the lens of the eye. The classification evaluates: P,C and NO. NO is graded on a decimal scale of 0.1 to 6.9, based on a set of 6 standardized photographs. C and P are graded on a decimal scale of 0.1 to 5.9, based on a set of 5 standardized photographs each.

To study if the treatment has effected on the visual acuity from baseline to months 6, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).

To study if the treatment has effected on the visual acuity from baseline to months 12, by using Best Corrected Visual Acuity (BCVA) as measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters. To assess the effect of palifermin on the incidence of cataract development or progression at Month 6 and Month 12 based on an increase of ≥ 0.3 in the Lens Opacities Classification System (LOCS III) score for Posterior Subcapsular cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO).

Incidence of Adverse Events CTCAE grade 3 or higher reported

Overall survival (OS) is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse.

Progression-free survival (PFS) is the length of time during and after the treatment during which the disease being treated does not get worse. In this study the event for Progression-free survival was death from all causes or disease progression. Time to each event was defined as the time elapsed between the date of the first dose of investigational product, and the date of the given event.

For the analysis of time to disease progression, competing risks time-to-event analysis was used, since a subject destined to develop disease progression could die from unrelated causes before the disease progression event takes place. Kaplan-Meier survival estimates, with death due to other causes than progression considered as a competing risk, were provided: event rate at 3 month intervals, with 95% confidence interval, the number of subjects at risk at the beginning of the time period, and the number of events of interest.

All comparisons for the long-term safety endpoints were based on the combined palifermin group versus placebo (placebo over palifermin). Incidence of new or secondary malignancies by treatment group was provided (incidence of new or secondary malignancies at the follow-up visit - yes, no, no assessment -, and number of subjects with new or secondary malignancies, per type of malignancies). The long-term safety evaluations were summarized for the subgroups defined by the factors used for randomization using descriptive statistics.

Swedish Orphan Biovitrum

Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). A total of 109 subjects were randomized to treatment and 107 received at least one dose of study treatment. Due to protocol deviations 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 111 subjects were included in this safety analysis set.

Palifermin Before Only

Subjects to receive matched placebo before- and after-high dose chemotherapy

Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). A total of 115 subjects were randomized to treatment and 113 received at least one dose of study treatment. Due to protocol deviations additional 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 109 subjects were included in this safety analysis set.

Palifermin Before and After

Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)

Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Germany

Hungary

France

Austria

Belgium

Czech Republic

Italy

Switzerland

United Kingdom

Finland

Netherlands

Ireland

Sweden

Denmark

Region of Enrollment

Medical Director

The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.

WHO grade 0/1 or 2

WHO grade 3 or 4

Unknown

Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy

Subjects to receive palifermin before- and after-high dose chemotherapy

Full analysis set that includes all randomized subjects, and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.

Maximum Severity of Oral Mucositis (World Health Organization (WHO) Grades 0/1, 2, 3, or 4)

Incidence (n): yes

Incidence (n): No

Incidence (n): unknown

Full analysis set that includes all randomized subjects (total 281 subjects), and was used to compare treatment effects for all efficacy endpoints. This set of subjects was analyzed according to their randomized treatment assignment.

Incidence Ulcerative Mucositis (WHO Grades 2, 3, and 4)

A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.

Duration of Ulcerative Mucositis (WHO Grades 2, 3, and 4)

For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.

The Area Under the Curve (AUC) Was Calculated From the Patient-reported Outcome Mouth and Throat Soreness (MTS) Score.

Missing

Subjects to receive Before- and After chemotherapy, and Before chemotherapy only

Palifermin

Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group. Number of patients with non-missing values at Months 6; were 17 in the placebo group and 53 in the palifermin group.

Incidence of Cataract Development or Progression (Change of ≥0.3 in Lens Opacities Classification System III (LOCS III Score)) at Month 6.

P month 6 - Yes

P, month 6 - No

P, month 12 - Yes

P, month 12 - No

C month 6 - Yes

C, month 6 - No

C, month 12 - Yes

C, month 12 - No

NO month 6 - Yes

NO month 6 - No

NO month 12 - Yes

NO month 12 - No

P, C and NO, month 6 - Subjects who discontinued

P, C and NO, month 12 - Subjects who discontinued

281 subjects participated in the acute phase study of those 101 subjects were eligible for the cataract assessment study, 22 placebo and 79 palifermin. Month 6: 69 completed (17/22 \[77.3%\] in the placebo, 52/79 \[65.8%\] in the palifermin. Month 12: 66 completed (14/22 \[63.6%\] in the placebo, 52/79 \[65.8%\] in the palifermin group.

Incidence of an Increase Posterior Subcapsular Cataract (P), Cortical Cataract (C) and Nuclear Opalescence (NO) at Month 6 and 12

Summary of difference from baseline in P

Summary of difference from baseline in C

Summary of difference from baseline in NO

Subjects to receive matched placebo before- and after-high dose chemotherapy.

Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.

All subjects in the acute phase study were also assessed for their eligibility for cataract assessment procedures according to predefined criteria. If a subject was not eligible for cataract assessment procedures, the subject could still have been eligible for inclusion in the study but was exempt from the cataract assessments.

Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 6.

Change From Baseline in Posterior Subcapsular (P), Cortical (C) Cataract and Nuclear Opalescence (NO) on the Lens Opacities Classification System III (LOCS III) Scale at Months 12.

Incidence of decrease in letters read - Yes

Incidence of decrease in letters read - No

Subjects who discontinued at Month 6

Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 6

Subjects who discontinued at month 12

Incidence of a Decreased From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by a Change of 10 Letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 Meters at Months 12.

Incidence of Adverse Events and Laboratory Abnormalities

All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.

Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)

Palifermin (Palifermin Before Only and, Before and After)

A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47

Overall Survival

Of the 281 subjects who participated in the acute phase of the study a total of 101 subjects study were eligible for participation in the cataract assessment procedures, 22 in the placebo group and 79 in the palifermin group.

Incidence of Cataract Development or Progression at Month 12.

A total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.

Progression Free Survival

Time Death or Disease Progression

total of 277 subjects were included in the Safety subset of the original study report (220 Palifermin and 57 placebo). Follow-up time for all subjects, defined as the date of randomization to the last known alive date. For subjects who were alive at the last contact the number of subjects for the palifermin group was 162 and for the placebo 47.

Incidence of Second Primary Malignancies or Other Malignancies

Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and placebo on Days 0, 1 and 2 after high dose chemotherapy.

Subjects to receive matched placebo before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of placebo as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy.

Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy

Overall Study

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Micronutrients

Herbal and Botanical

Leucovorin

Fluorouracil

Mitogens

Cola

50 subjects to receive palifermin 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.

50 subjects to receive matched placebo 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.

dose of 120 μg/kg, intravenous (IV) on day -3 for each cycle, for up to 6 chemotherapy cycles

palifermin

one bolus IV injection at 120 μg/kg/day of matched placebo

placebo

The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral mucositis in subjects with stage 2B and 3 locally advanced, colon cancer receiving chemotherapy as an adjuvant treatment for their disease.

This study is being conducted to determine whether administration of a single IV dose of palifermin 3 days before initiation of chemotherapy and 3 days before each subsequent treatment cycle would reduce the incidence of oral mucositis and to evaluate the safety profile in the subject population. This study will evaluate the efficacy of palifermin in reducing the incidence of grade ≥ 2 OM in subjects with stage 2B or stage 3 locally advanced, colon cancer undergoing adjuvant chemotherapy with 5-FU and leucovorin in cycle 1. This study will also assess the safety and tolerability of palifermin administered as a single IV dose before each cycle of 5-FU and leucovorin, evaluate the effect of palifermin on patient-reported mouth and throat soreness, the incidence of grade ≥ 2 oral mucositis in cycle 2, the duration of grade ≥ 2 oral mucositis, 5-FU dose reductions/delays and the long-term effects of palifermin on disease outcome and survival.

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) for Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer Receiving 5-FU and Leucovorin as Adjuvant Therapy

Amgen

Head and Neck Neoplasms

Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course

Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.

The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent chemotherapy as adjuvant treatment for their disease.

This study is being conducted to evaluate the efficacy of palifermin administered intravenously (IV) in weekly doses (minimum of 7 weekly doses, until RT was complete) in reducing the incidence of severe (World Health Organization \[WHO\] grade 3 or 4) oral mucositis in subjects with locally advanced HNC receiving RT concurrent with CT (RT/CT) as adjuvant treatment for their disease (postoperative setting). This study will assess the safety and tolerability of palifermin at the dose of 120 μg/kg IV administered weekly (minimum 7 weekly doses, until RT was complete) in this subject population. This study will also evaluate the effect of palifermin on the clinical sequelae of severe OM (eg, average subject-reported mouth and throat soreness \[MTS\] score), and on RT-induced xerostomia in this population, as well as the long-term effects of palifermin on disease outcome and survival in this population.

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer

Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy(RT/CT)

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.

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.

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.

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

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.

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 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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma	NCT00434161	Multiple Myelom...	Palifermin befo... Placebo Palifermin befo...	18 Years - 70 Years	Swedish Orphan Biovitrum
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer	NCT00393822	Colon Cancer	palifermin placebo	18 Years -	Amgen
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer	NCT00393822	Colon Cancer	palifermin placebo	18 Years -	Amgen
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer	NCT00131638	Head and Neck C...	Placebo Palifermin	18 Years -	Amgen
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer	NCT00131638	Head and Neck C...	Placebo Palifermin	18 Years -	Amgen
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer	NCT00393822	Colon Cancer	palifermin placebo	18 Years -	Amgen
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy	NCT00540332	Head and Neck C...	Placebo palifermin	18 Years -	Swedish Orphan Biovitrum
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer	NCT00131638	Head and Neck C...	Placebo Palifermin	18 Years -	Amgen
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer	NCT00101582	Mucositis Solid Tumors Stomatitis Head and Neck C... Squamous Cell C...	Placebo palifermin cisplatin chemo... Radiotherapy	18 Years -	Swedish Orphan Biovitrum

Spots Global Cancer Trial Database for kgf

Every month we try and update this database with for kgf cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for kgf

Every month we try and update this database with for kgf cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for kgf cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.