Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Immunoglobulins

Mitogens

Zalutumumab

Antineoplastic Agents, Immunological

Zalutumumab in combination with radiotherapy for 8 weeks. The treatment period of 8 weeks is followed by a 3 week follow-up period where all adverse events are collected and then additionally a 2 year follow-up period where only serious adverse events are collected.

Philippe MAIGON

The purpose of this study is to investigate the safety of zalutumumab in combination with radiotherapy as the treatment of patients with head and neck cancer who are not eligible for platinum based chemotherapy.

This is an open label, multi-center, phase I/II dose-escalation clinical trial investigating the safety of zalutumumab in combination with radiotherapy. The safety of zalutumumab doses in combination with radiotherapy (RT) will be investigated using 3 patient cohorts in a dose-escalation / de-escalation design based on Dose Limiting Toxicity (DLT). The dose-escalation starts at 8 mg/kg zalutumumab in combination with RT. Initially, three patients will be treated at a dose level and observed for DLTs. If none of the three patients experience a DLT, then the next cohort of three patients is treated at the next higher dose of zalutumumab. If one of three patients treated at a dose level experience a DLT, then three more patients are treated at the same dose level. If two or more of the three patients experience DLTs, then the next cohort of three patients should be treated at the next lower dose of zalutumumab, unless at least six patients on that dose have already been dosed. Furthermore, if 1 or fewer DLTs are observed among six patients at a given dose level, then the next cohort of three patients is treated at the next higher dose of zalutumumab. The maximum tolerated dose will be decided by Genmab based on the recommendations made by the IDMC on the basis of their review of the aggregated safety data.

Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy

An Open-label, International, Multi-Center, Phase I/II, Dose-escalation Trial Investigating the Safety of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Combination With Radiotherapy, in Patients With Stage III, IVa or IVb Locally Advanced Squamous Cell Carcinoma of the Head and Neck Ineligible for Platinum Based Chemotherapy

Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.

The Best Overall Tumour Response defined as the best response recorded from the start of treatment until disease progression or recurrence per RECIST criteria. Complete response (CR) defined as the disappearance of all target lesions. Partial response (PR) defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD) defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions since the prior scan. Stable disease (SD) defined as responses not fulfilling CR, PR or PD.

Objective response is defined as CR or PR according to RECIST criteria. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.

Genmab

Zalutumumab 4 mg/kg

Zalutumumab 8 mg/kg

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

France

United Kingdom

Region of Enrollment

All adverse events were collected during the 8 week treatment period and for 4 additional weeks. Serious adverse events were collected for the extended follow-up period of 2 years.

Eva Järlid Westerberg, VP Clinical Operations

Analysis set included all 8 participants who were enrolled in the study.

Number of Participants With Adverse Events (AEs)

Complete response

Partial response

Stable disease

Progressive disease

Analysis set included all 8 participants who were enrolled in the study. Overall number of participants analyzed are the participants who are available for the assessment.

Number of Participants With Best Overall Tumour Response

Number of Participants With Objective Response

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Docetaxel

Cisplatin

Combination of cisplatin and docetaxel administered as two cycles given every three weeks

Induction chemotherapy

Radiotherapy

Steen Lisby, MD, PHD

The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer

A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients

Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16

Number of participants reporting at least one adverse event

Age Continuous

United States

Belgium

Netherlands

The trial was prematurely closed. The original protocol contained Part 1A, followed by Part 1B and Part 2. The trial was terminated when 13 patients were enrolled in Part 1A. Scans for efficacy were planned for Part 1B and Part 2.

Eva Järlid Westerberg PhD

Zalatumumab 8 mg/kg

Number of patients reporting at least one adverse event

Adverse Events

Data was not collected. Imaging scans were not taken during part 1A. The trial was prematurely closed when 13 patients were enrolled in part 1A. Scans were planned for part 1B and 2. No patients continued to part 1B and part 2.

Progression Free Survival Verified by Imaging Techniques.

zalutumumab

cisplatin

Vincent Gregoire, MD professor

The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with head and neck cancer

Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer

An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled

Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.

Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR

Zalutumumab 12 mg/kg

Zalutumumab 16 mg/kg

Sweden

All adverse events were collected during the 8 week treatment period and for additional 4 weeks. Serious adverse events were collected for the extended follow-up period of up to 3 years.

The planned parallell group of the study was cancelled.

Overall Response

Number of months between date of first infusion and date of best response

Time to Response

Nonevaluable

Best Overall Tumor Response

Antibodies, Monoclonal

zalutumumab 4 mg/kg iv single infusion week 1,3, 4 and 5

zalutumumab 8 mg/kg iv single infusion week 1, 3, 4 and 5

zalutumumab 16 mg/kg iv single infusion week 1, 3, 4 and 5

Zalutumumab is a clear to opalescent liquid. It is intended for intravenous infusion following dilution in sterile, pyrogen free, 0.9% NaCl. Patients will be treated at a specified dose of Zalutumumab over a period of 7 weeks. The dose will be 4mg/kg, 8mg/kg or 16mg/kg depending on when they enter the study. The study will begin with 6 patients on 4mg/kg, then 10 patients on 8mg/kg and lastly 10 patients on 16mg/kg.

Jean-Pascal Machiels, MD, PhD

This study is to support current and future Zalutumumab studies by increasing the Pharmacokinetic (PK) knowledge of the drug. PK is the study of how a drug is absorbed (taken up), distributed (moved around), metabolised (broken down) and excreted (removed) by the body, in relation to time. The first PK trial only went up to 8 mg/kg, and, as there has been some indication that the PK profile for the higher and lower doses is different, this needs to be further evaluated. Furthermore, there is a need for more PK data on dosing with 16mg/kg.

The aim with this study is therefore to evaluate the PK profiles at different doses of Zalutumumab and the amount of drug in the blood at different time points after single and multiple doses. The results of this study, combined with data from completed and ongoing Zalutumumab studies, will enable us to provide patients with an effective treatment option which may significantly prolong their survival and/or improve their quality of life.

This study is to look at the Pharmacokinetics (PK) of Zalutumumab in patients with Head and Neck Cancer. 26 participants will be treated with the study drug Zalutumumab at 4 different doses. Zalutumumab will be given at day 0, day 14, day 21 and day 28. Blood samples (for PK and to check the participant's safety) will be taken before drug is given. Blood samples for PK only will be taken directly after drug is given at all treatment visits and also at +3hr and +12hrs on day 0 and day 28 which may require an overnight stay.

Blood samples for PK only are also taken on days between treatments. After treatment on day 28, eight more blood samples will be taken over 3 weeks. On day 49 participants may enter an optional extended treatment period receiving the drug weekly until it is no longer appropriate for the participant (doctor/participant decision or cancer has advanced).

Dosing in the extended treatment period will start at 16mg/kg. The correct dose for the participant will be checked at each visit by looking for the presence and severity of skin rash. This is a common side effect of medicines like Zalutumumab which block the Epidermal Growth Factor Receptor. The severity of the skin rash is used as a guide for dosing. A mild rash could mean more medication is needed, a severe rash will mean the participant needs a break from the medication. End of study is 8 weeks after the last dose of Zalutumumab and blood samples will be taken +4weeks and +8weeks after the last dose of drug.

Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic Profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Non-curable Patients With SCCHN

Hungary

Slovakia

Thirty of the 31 enrolled participants were included in the full analysis set (FAS) population. One participant was excluded from the FAS because he died before the first infusion of trial drug.

PK parameter calculation for the fourth infusion was not performed for 3 participants: one participant \[8 mg/kg\] was withdrawn from treatment before infusion 4 and for two participants \[4 mg/kg, 8 mg/kg\] no infusion 4 was documented and only concentrations before dosing were reported. Overall number of participants analyzed are the number of participants with data available for analysis.

Maximum Plasma Concentration of Zalutumumab After Fourth Infusion

Area Under the Curve 0-7 Days

Area Under the Curve 0-21 Days

Elimination Half-life

Clearance

Apparent Volume of Distribution During the Terminal Phase

Apparent Volume of Distribution at Steady State

Symptoms and General Pathology

Disease Progression

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

IV infusion, 16mg/kg on weekly basis until DP

Not applicable, Study cancelled

A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients with Non-Small Cell Lung Cancer who have Progressive Disease after Treatment with Tyrosine Kinase Inhibitors.

Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors

A Single-arm Phase II Trial Investigating the Efficacy and Safety of Zalutumumab in Patients With Non-Small Cell Lung Cancer Who Have Progressive Disease After Treatment With Tyrosine Kinase Inhibitors

Immunologic Factors

Zalutumumab in combination with Best Supportive Care

Individual dose titration weekly i.v doses

Control

The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer

This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.

Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.

Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.

Zalutumumab in Patients With Non-curable Head and Neck Cancer

An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy

A patient's overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.

Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR

Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented.

PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient.

The safety analysis population included all 283 patients who had attended Visit 2.

Serbia

Estonia

Spain

Lithuania

Russian Federation

Canada

Brazil

Poland

The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.

Overall Survival

Not evaluable

Objective Tumor Response

Duration of Response

Progression Free Survival (PFS)

Zalutumumab in combination with Best Supportive Care. Patients received weekly infusions of zalutumumab. After a loading dose of 8 mg/kg the dose was reduced to 4 mg/kg and individual dose titration based on skin rash evaluation was performed.

Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.

Individual dose titration weekly i.v. doses

Steen Lisby, MD

Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Zalutumumab in Non-curable Patients With SCCHN

An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.

OS was defined as time from start of treatment until date of death of any cause.

Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.

DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.

PFS is defined as the time from start of treatment until disease progression or death.

Zalutumumab 4-16 mg/kg

Portugal

Czech Republic

Peru

Austria

Israel

Chile

Germany

Colombia

Italy

All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.

This was an uncontrolled single-arm open-label trial with no formal statistical tests planned.

Overall Survival (OS)

Stable response

All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. Overall number of participants analyzed are number of participants with data available for analysis of best response.

Objective Tumour Response

All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. Overall number of participants analyzed are the number of participants with a response.

Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4) + Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Radiotherapy 66-68 Gy, 2Gy/fx, 6 fx/week (+ weekly cisplatin 40 mg/m2 during radiotherapy to stage 3+4)

Zalutumumab 8 mg/kg every week during radiotherapy + the week before start of radiotherapy (as loading dose)

Jens Overgaard, Prof. MD

The purpose of this study is to determine whether the addition of the fully human EGFr antibody zalutumumab to primary curative radiotherapy increases locoregional control in Squamous Cell Carcinomas of the Head and Neck.

Radiotherapy to Squamous Cell Carcinomas of the Head and Neck have been modified during the last decades by altered fractionation, the addition of concomitant chemotherapy or modification of hypoxia. By these modifications the locoregional control, disease-specific survival or overall survival have been increased but the price have been increased morbidity.

The addition of antibodies against the Epidermal Growth Factor receptor (EGFR-I) may further increase the control and survival of patients with Squamous Cell Carcinomas of the Head and Neck when combined with radiotherapy and/or chemotherapy.

The aim of the present study is to determine whether

1. The addition af the EGFr-I zalutumumab increases locoregional control in Squamous Cell Carcinomas of the Head and Neck
2. Whether disease-specific survival or overall survival is improved by addition of zalutumumab
3. Whether the addition of zalutumumab to primary curative radiotherapy or chemoradiotherapy is feasible and tolerable
4. Acute and late toxicity to the treatment.

DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC

DAHANCA 19: A Randomized Study of the Importance of the EGFr-Inhibitor Zalutumumab for the Outcome After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy	NCT00707655	Head and Neck C... Squamous Cell C...	Zalutumumab	18 Years -	Genmab
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer	NCT00460551	Non Small Cell ...	Zalutumumab Induction chemo... Radiotherapy	18 Years -	Genmab
Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy	NCT00707655	Head and Neck C... Squamous Cell C...	Zalutumumab	18 Years -	Genmab
Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer	NCT00401401	Head and Neck C... Squamous Cell C...	zalutumumab cisplatin Radiotherapy	18 Years -	Genmab
Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)	NCT01054625	Head and Neck C...	zalutumumab	18 Years -	Genmab
Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer	NCT00401401	Head and Neck C... Squamous Cell C...	zalutumumab cisplatin Radiotherapy	18 Years -	Genmab
Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors	NCT01449357	Non-small Cell ...	zalutumumab	18 Years -	Genmab
Zalutumumab in Patients With Non-curable Head and Neck Cancer	NCT00382031	Head and Neck C... Squamous Cell C...	Zalutumumab Control	18 Years -	Genmab
Zalutumumab in Non-Small Cell Lung Cancer (NSCLC) Patients Refractory to Tyrosine Kinase Inhibitors	NCT01449357	Non-small Cell ...	zalutumumab	18 Years -	Genmab
Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)	NCT01054625	Head and Neck C...	zalutumumab	18 Years -	Genmab
Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer	NCT00401401	Head and Neck C... Squamous Cell C...	zalutumumab cisplatin Radiotherapy	18 Years -	Genmab
Zalutumumab in Non-curable Patients With SCCHN	NCT00542308	Head and Neck C... Squamous Cell C...	Zalutumumab	18 Years -	Genmab
DAHANCA 19: The Importance of the EGFr-inhibitor Zalutumumab for the Outcome After Curative Radiotherapy for HNSCC	NCT00496652	Cancer of the H...	Radiotherapy Zalutumumab	18 Years -	Danish Head and Neck Cancer Group

Spots Global Cancer Trial Database for zalutumumab

Every month we try and update this database with for zalutumumab 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 zalutumumab

Every month we try and update this database with for zalutumumab 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 zalutumumab 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.