Trial Outcomes & Findings for Zalutumumab in Patients With Non-curable Head and Neck Cancer (NCT NCT00382031)

NCT ID: NCT00382031

Last Updated: 2013-10-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

286 participants

Primary outcome timeframe

From randomization until death

Results posted on

2013-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Zalutumumab 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.	Control Best Supportive Care
Overall Study STARTED	191	95
Overall Study COMPLETED	191	95
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Zalutumumab in Patients With Non-curable Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zalutumumab n=191 Participants Zalutumumab in combination with Best Supportive Care	Control n=95 Participants Best Supportive Care	Total n=286 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	161 Participants n=93 Participants	77 Participants n=4 Participants	238 Participants n=27 Participants
Age, Categorical >=65 years	30 Participants n=93 Participants	18 Participants n=4 Participants	48 Participants n=27 Participants
Age Continuous	57 years STANDARD_DEVIATION 9 • n=93 Participants	57 years STANDARD_DEVIATION 9 • n=4 Participants	57 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	12 Participants n=4 Participants	34 Participants n=27 Participants
Sex: Female, Male Male	169 Participants n=93 Participants	83 Participants n=4 Participants	252 Participants n=27 Participants
Region of Enrollment Serbia	5 participants n=93 Participants	1 participants n=4 Participants	6 participants n=27 Participants
Region of Enrollment Estonia	3 participants n=93 Participants	1 participants n=4 Participants	4 participants n=27 Participants
Region of Enrollment Spain	1 participants n=93 Participants	4 participants n=4 Participants	5 participants n=27 Participants
Region of Enrollment Lithuania	2 participants n=93 Participants	0 participants n=4 Participants	2 participants n=27 Participants
Region of Enrollment Russian Federation	42 participants n=93 Participants	22 participants n=4 Participants	64 participants n=27 Participants
Region of Enrollment United Kingdom	22 participants n=93 Participants	10 participants n=4 Participants	32 participants n=27 Participants
Region of Enrollment France	13 participants n=93 Participants	3 participants n=4 Participants	16 participants n=27 Participants
Region of Enrollment Hungary	37 participants n=93 Participants	20 participants n=4 Participants	57 participants n=27 Participants
Region of Enrollment Canada	10 participants n=93 Participants	8 participants n=4 Participants	18 participants n=27 Participants
Region of Enrollment Brazil	7 participants n=93 Participants	4 participants n=4 Participants	11 participants n=27 Participants
Region of Enrollment Belgium	31 participants n=93 Participants	20 participants n=4 Participants	51 participants n=27 Participants
Region of Enrollment Poland	14 participants n=93 Participants	2 participants n=4 Participants	16 participants n=27 Participants
Region of Enrollment Sweden	4 participants n=93 Participants	0 participants n=4 Participants	4 participants n=27 Participants

PRIMARY outcome

Timeframe: From randomization until death

Population: 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.

Outcome measures

Outcome measures
Measure	Zalutumumab n=191 Participants Zalutumumab in combination with Best Supportive Care	Control n=95 Participants Best Supportive Care
Overall Survival	6.7 months Interval 5.8 to 7.1	5.2 months Interval 4.1 to 6.4

SECONDARY outcome

Timeframe: From date of randomization until the date of death from any cause, assessed up to 41 months.

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

Outcome measures

Outcome measures
Measure	Zalutumumab n=191 Participants Zalutumumab in combination with Best Supportive Care	Control n=95 Participants Best Supportive Care
Objective Tumor Response Complete response	2 participants	0 participants
Objective Tumor Response Partial response	10 participants	1 participants
Objective Tumor Response Stable disease	79 participants	25 participants
Objective Tumor Response Progressive disease	70 participants	38 participants
Objective Tumor Response Not evaluable	30 participants	31 participants

SECONDARY outcome

Timeframe: Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.

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.

Outcome measures

Outcome measures
Measure	Zalutumumab n=12 Participants Zalutumumab in combination with Best Supportive Care	Control n=1 Participants Best Supportive Care
Duration of Response	5.5 month Interval 3.6 to 23.0	7.4 month CI not available as it was only one patient

SECONDARY outcome

Timeframe: From randomization until disease progression or death, assessed up to 41 months.

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.

Outcome measures

Outcome measures
Measure	Zalutumumab n=191 Participants Zalutumumab in combination with Best Supportive Care	Control n=95 Participants Best Supportive Care
Progression Free Survival (PFS)	9.9 weeks Interval 8.7 to 15.0	8.4 weeks Interval 8.1 to 9.6

Adverse Events

Zalutumumab

Serious events: 180 serious events

Other events: 188 other events

Deaths: 0 deaths

Control

Serious events: 87 serious events

Other events: 92 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zalutumumab n=189 participants at risk Zalutumumab in combination with Best Supportive Care	Control n=94 participants at risk Best Supportive Care
General disorders General disorders and administration site conditions	67.2% 127/189 • Number of events 138 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	67.0% 63/94 • Number of events 64 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
General disorders Disease progression	62.4% 118/189 • Number of events 118 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	63.8% 60/94 • Number of events 60 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	20.1% 38/189 • Number of events 48 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	23.4% 22/94 • Number of events 27 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour hemorrhage	16.9% 32/189 • Number of events 41 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	14.9% 14/94 • Number of events 17 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Infections and infestations Infections and Infestations	18.5% 35/189 • Number of events 46 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	11.7% 11/94 • Number of events 11 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Infections and infestations Pneumonia	7.4% 14/189 • Number of events 15 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	3.2% 3/94 • Number of events 3 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Gastrointestinal disorders Gastrointestinal disorders	10.1% 19/189 • Number of events 20 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	3.2% 3/94 • Number of events 3 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Gastrointestinal disorders Dysphagia	5.3% 10/189 • Number of events 10 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	2.1% 2/94 • Number of events 2 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.

Other adverse events

Other adverse events
Measure	Zalutumumab n=189 participants at risk Zalutumumab in combination with Best Supportive Care	Control n=94 participants at risk Best Supportive Care
General disorders General disorders and administration site conditions	84.1% 159/189 • Number of events 359 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	83.0% 78/94 • Number of events 161 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	92.1% 174/189 • Number of events 355 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	10.6% 10/94 • Number of events 13 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Gastrointestinal disorders Gastrointestinal disorders	54.0% 102/189 • Number of events 298 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	45.7% 43/94 • Number of events 119 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	42.3% 80/189 • Number of events 177 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	35.1% 33/94 • Number of events 51 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Infections and infestations Infections and Infestations	41.8% 79/189 • Number of events 171 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	30.9% 29/94 • Number of events 35 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Metabolism and nutrition disorders Metabolism and nutrition disorders	40.7% 77/189 • Number of events 150 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	21.3% 20/94 • Number of events 27 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Blood and lymphatic system disorders Blood and lymphatic system disorders	34.9% 66/189 • Number of events 121 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	27.7% 26/94 • Number of events 44 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Nervous system disorders Nervous system disorders	37.0% 70/189 • Number of events 114 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	23.4% 22/94 • Number of events 38 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	26.5% 50/189 • Number of events 75 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	31.9% 30/94 • Number of events 39 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	24.3% 46/189 • Number of events 78 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	28.7% 27/94 • Number of events 41 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Investigations Investigations	29.6% 56/189 • Number of events 77 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	12.8% 12/94 • Number of events 14 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Vascular disorders Vascular disorders	14.8% 28/189 • Number of events 38 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	7.4% 7/94 • Number of events 9 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.
Eye disorders Eye disorders	12.7% 24/189 • Number of events 37 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.	5.3% 5/94 • Number of events 5 • Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group. The safety analysis population included all 283 patients who had attended Visit 2.

Additional Information

Eva Järlid Westerberg, VP Clinical Operations

Genmab A/S

Phone: +45 7020 2728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The site and the PI may be required to withhold the publication for up to 90 days. Subject to a reasoned request from the sponsor, the publication may be further delayed for a period up to 6 months from the date of first submission to the sponsor. The sponsor has the right to require deletion of any trade secret, proprietary, or confidential information supplied by the sponsor to the site or the PI. The sponsor shall not otherwise have the right to censor publications.
Publication restrictions are in place

Restriction type: OTHER