Trial Outcomes & Findings for Identification of Gene Expression Signature for Panitumumab Sensitivity in Untreated Locally Advanced SCCHN (NCT NCT01305772)
NCT ID: NCT01305772
Last Updated: 2014-08-29
Results Overview
The aim of this outcome measure was to identify a gene expression signature that predicts response to panitumumab in untreated locally advanced squamous cell cancer of the head / neck (SCCHN). Response and progression were evaluated using the largest percentage change among the cases: 1) Pre-panitumumab PET scan activity, and/or; 2) Pre-panitumumab radiologic measurement compared to post-panitumumab measurement and/or; 3) Pre-panitumumab direct measurement of tumor / lymph node compared to post-panitumumab direct measurement of tumor / lymph node. Response and progression were evaluated in this single study using the criteria "changes in only the largest diameter (unidimensional measurement) of the tumor lesions were defined" in the same manner as in RECIST 1.1. No results are reported as only 2 of the 6 subjects had fresh tissue collected after the first dose of panitumumab. The study was amended to remove the biopsy procedure due to the potential risk for the participants.
TERMINATED
PHASE2
6 participants
Baseline to 2 years
2014-08-29
Participant Flow
All patients had successful genomic screening and RNA extraction/quality control.
Participant milestones
| Measure |
Radiation Therapy
Patients who underwent radiation therapy only, in conjunction with panitumumab therapy.
Radiation Therapy : Radiation therapy was initiated within 8 weeks after surgery, or as soon as possible.
Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 \& 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 \& 4 during RT.
|
Surgery
Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration
Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 \& 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 \& 4 during RT.
Surgery : Second biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site).
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
1
|
|
Overall Study
Genomic Screening + Biopsy #1
|
5
|
1
|
|
Overall Study
Research PET/CT #1
|
5
|
1
|
|
Overall Study
Panitumumab Dose #1
|
5
|
1
|
|
Overall Study
Research PET/CT #2
|
5
|
1
|
|
Overall Study
Surgery/Biopsy #2
|
1
|
1
|
|
Overall Study
RT + Panitumumab Dose #2 / #3
|
5
|
1
|
|
Overall Study
COMPLETED
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Identification of Gene Expression Signature for Panitumumab Sensitivity in Untreated Locally Advanced SCCHN
Baseline characteristics by cohort
| Measure |
Radiation Therapy
n=5 Participants
Patients who underwent radiation therapy only, in conjunction with panitumumab therapy
|
Surgery
n=1 Participants
Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.60 years
STANDARD_DEVIATION 6.66 • n=5 Participants
|
69 years
STANDARD_DEVIATION NA • n=7 Participants
|
65.33 years
STANDARD_DEVIATION 6.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 yearsPopulation: No results will be reported for the primary outcome measure as only 2 of the 6 subjects had tissue collected after the first dose of panitumumab due to safety risk to the subject.
The aim of this outcome measure was to identify a gene expression signature that predicts response to panitumumab in untreated locally advanced squamous cell cancer of the head / neck (SCCHN). Response and progression were evaluated using the largest percentage change among the cases: 1) Pre-panitumumab PET scan activity, and/or; 2) Pre-panitumumab radiologic measurement compared to post-panitumumab measurement and/or; 3) Pre-panitumumab direct measurement of tumor / lymph node compared to post-panitumumab direct measurement of tumor / lymph node. Response and progression were evaluated in this single study using the criteria "changes in only the largest diameter (unidimensional measurement) of the tumor lesions were defined" in the same manner as in RECIST 1.1. No results are reported as only 2 of the 6 subjects had fresh tissue collected after the first dose of panitumumab. The study was amended to remove the biopsy procedure due to the potential risk for the participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 monthsNine month progression-free survival (PFS) was defined from the time from enrollment to the first date of disease progression or death as a result of any cause. Progression was defined in the same manner as in RECIST 1.1: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5mm (the appearance of one or more new lesions is also considered progression). Time was censored at the date of the last follow-up visit for subjects who were still alive and have not progressed. The 9 month PFS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are disease free or alive.
Outcome measures
| Measure |
Overall Study
n=6 Participants
Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
|
|---|---|
|
Nine (9) Month Progression Free Survival (PFS)
|
60 percentage of treated patients
Interval 12.57 to 88.18
|
SECONDARY outcome
Timeframe: 9 monthsOverall survival (OS) was defined as from the time of enrollment to the date of death resulting from any cause. Time as censored at the date of the last follow-up visit for subjects who were still alive. The 9-month OS rate is a percentage, representing the fraction of treated subjects who, after 9 months, are alive.
Outcome measures
| Measure |
Overall Study
n=6 Participants
Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
|
|---|---|
|
Nine (9) Month Overall Survival (OS)
|
80 percentage of treated patients surviving
Interval 20.38 to 96.92
|
Adverse Events
Radiation Therapy
Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Radiation Therapy
n=5 participants at risk
Radiation therapy with panitumumab therapy.
|
Surgery
n=1 participants at risk
Surgery after research PET/CT scans and subsequent radiation therapy with panitumumab therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
4/5
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: Granulocytes
|
20.0%
1/5
|
0.00%
0/1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5
|
100.0%
1/1
|
|
Blood and lymphatic system disorders
Lymph node pain
|
20.0%
1/5
|
0.00%
0/1
|
|
Ear and labyrinth disorders
Ear pain
|
20.0%
1/5
|
0.00%
0/1
|
|
Ear and labyrinth disorders
Hearing impaired
|
20.0%
1/5
|
0.00%
0/1
|
|
Eye disorders
Eye disorders - Other, specify: Eye Itching
|
60.0%
3/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Constipation
|
80.0%
4/5
|
100.0%
1/1
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
5/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dyspepsia
|
60.0%
3/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dysphagia
|
60.0%
3/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Esophageal pain
|
40.0%
2/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Esophagitis
|
20.0%
1/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Odonyphagia
|
100.0%
5/5
|
100.0%
1/1
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
1/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
20.0%
1/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Stomach pain
|
20.0%
1/5
|
0.00%
0/1
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5
|
100.0%
1/1
|
|
General disorders
Chills
|
20.0%
1/5
|
100.0%
1/1
|
|
General disorders
Edema face
|
20.0%
1/5
|
100.0%
1/1
|
|
General disorders
Edema limbs
|
20.0%
1/5
|
0.00%
0/1
|
|
General disorders
Fatigue
|
100.0%
5/5
|
100.0%
1/1
|
|
General disorders
Fever
|
40.0%
2/5
|
0.00%
0/1
|
|
General disorders
Pain
|
0.00%
0/5
|
100.0%
1/1
|
|
Infections and infestations
Gum infection
|
60.0%
3/5
|
0.00%
0/1
|
|
Infections and infestations
Infections and infestations - Other, specify: Face
|
20.0%
1/5
|
0.00%
0/1
|
|
Infections and infestations
Skin infection
|
60.0%
3/5
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
100.0%
5/5
|
0.00%
0/1
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
0.00%
0/5
|
100.0%
1/1
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5
|
0.00%
0/1
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5
|
100.0%
1/1
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5
|
0.00%
0/1
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5
|
100.0%
1/1
|
|
Investigations
Platelet count decreased
|
40.0%
2/5
|
100.0%
1/1
|
|
Investigations
Weight loss
|
100.0%
5/5
|
100.0%
1/1
|
|
Investigations
White blood cell decreased
|
60.0%
3/5
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
5/5
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Dehydration
|
80.0%
4/5
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
80.0%
4/5
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
60.0%
3/5
|
0.00%
0/1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
80.0%
4/5
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
60.0%
3/5
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
5/5
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5
|
100.0%
1/1
|
|
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
|
20.0%
1/5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Muscle weakness - Area N/A
|
60.0%
3/5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5
|
0.00%
0/1
|
|
Nervous system disorders
Ataxia
|
20.0%
1/5
|
0.00%
0/1
|
|
Nervous system disorders
Depressed level of consciousness
|
20.0%
1/5
|
0.00%
0/1
|
|
Nervous system disorders
Dizziness
|
80.0%
4/5
|
0.00%
0/1
|
|
Nervous system disorders
Dysgeusia
|
100.0%
5/5
|
100.0%
1/1
|
|
Nervous system disorders
Headache
|
20.0%
1/5
|
0.00%
0/1
|
|
Nervous system disorders
Memory impairment
|
20.0%
1/5
|
0.00%
0/1
|
|
Nervous system disorders
Nervous system disorders - Other, specify: Mood alteration - Type N/A
|
20.0%
1/5
|
0.00%
0/1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5
|
100.0%
1/1
|
|
Nervous system disorders
Syncope
|
0.00%
0/5
|
100.0%
1/1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5
|
100.0%
1/1
|
|
Psychiatric disorders
Confusion
|
40.0%
2/5
|
100.0%
1/1
|
|
Psychiatric disorders
Insomnia
|
40.0%
2/5
|
0.00%
0/1
|
|
Renal and urinary disorders
Urinary incontinence
|
20.0%
1/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
20.0%
1/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
3/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5
|
100.0%
1/1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
20.0%
1/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
20.0%
1/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
20.0%
1/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
20.0%
1/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
40.0%
2/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5
|
100.0%
1/1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
20.0%
1/5
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
20.0%
1/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
1/5
|
100.0%
1/1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
40.0%
2/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
20.0%
1/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
20.0%
1/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5
|
100.0%
1/1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
80.0%
4/5
|
100.0%
1/1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
2/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Erythema
|
0.00%
0/5
|
100.0%
1/1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
20.0%
1/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
20.0%
1/5
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
20.0%
1/5
|
0.00%
0/1
|
|
Vascular disorders
Hypotension
|
60.0%
3/5
|
100.0%
1/1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place