Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imprime PGG | Experimental | Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin |
|
| Control | Active Comparator | Cetuximab + Paclitaxel/Carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imprime PGG Injection | Biological | 4 mg/kg i.v. over 2 hrs, weekly, in three week cycles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review | Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. | From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in Each Study Arm Based on the Safety Population | Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates. |
Not provided
Inclusion Criteria:
Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
Is between the ages of 18 and 75 years old, inclusive
Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
Has an ECOG performance status of 0 or 1
Has a life expectancy of > 3 months
Has adequate hematologic function as evidenced by:
Has adequate renal function as evidenced by:
Has adequate hepatic function as evidenced by:
If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.
Exclusion Criteria:
Has received prior systemic chemotherapy at any time for lung cancer;
Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
Has a known hypersensitivity to baker's yeast, or has an active yeast infection
Has had previous exposure to Betafectin® or Imprime PGG
Has an active infection
Presents with any of the following medical diagnoses/conditions at the time of screening:
Has a history of any of the following medical diagnoses/conditions:
Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab
Has a know sensitivity to Cremophor EL
Has previously received treatment with cetuximab
If female, is pregnant or breast-feeding
Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication)
Has previously received an organ or progenitor/stem cell transplant.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Folker Schneller, MD | Technical University, Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Georgia | Augusta | Georgia | 30912 | United States | ||
| Providence Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28303530 | Derived | Thomas M, Sadjadian P, Kollmeier J, Lowe J, Mattson P, Trout JR, Gargano M, Patchen ML, Walsh R, Beliveau M, Marier JF, Bose N, Gorden K, Schneller F 3rd. A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3-1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer. Invest New Drugs. 2017 Jun;35(3):345-358. doi: 10.1007/s10637-017-0450-3. Epub 2017 Mar 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 90 participants enrolled, 88 participants received at least one dose of study treatment, and 2 participants did not receive any study treatment.
A randomized, Simon 2-stage flexible design with 22 patients enrolled in stage 1 and 68 additional patients in stage 2, for a total of 90 subjects (60 in the Imprime PGG arm and 30 in the Control arm) enrolled competitively across US and German clinical sites.
First subject enrolled: 17 Aug 2009 Last subject last visit: 15 Nov 2012
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Imprime PGG Arm | Imprime PGG® infusion: 4 mg/kg i.v. over 2 to 4 hrs on Days 1, 8 and 15 of each 3-week treatment cycle; Cetuximab infusion: initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle; Paclitaxel infusion: 200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles Carboplatin infusion: dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles. Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of Imprime PGG and cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cetuximab |
| Biological |
initial loading dose of 400 mg/m^2 over 120 min and subsequent doses at 250 mg/m^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle |
|
|
| Paclitaxel | Drug | 200 mg/m^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles |
|
|
| Carboplatin | Drug | dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles |
|
|
| From the time of randomization to death, subject being lost to follow-up or study completion |
| Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review | The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. | From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months |
| Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review | The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. | From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months |
| Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review | The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. | From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months |
| Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review | Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator. If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date. | From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months |
| Terre Haute |
| Indiana |
| 47802 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mary Crowley Medical Research Center | Dallas | Texas | 75201 | United States |
| Allison Cancer Center | Midland | Texas | 79701 | United States |
| Helios Clinic Emil von Behring | Berlin | Germany |
| Municipal Clinic Frankfurt Hoescht | Frankfurt | Germany |
| Georg-August University Gottingen | Göttingen | 37075 | Germany |
| University Clinical Heidelberg | Heidelberg | Germany |
| Clinic Minden | Minden | Germany |
| Techincal University of Munich | Munich | Germany |
| Clinic Nurnberg Nord | Nuremberg | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| HELIOS Klinikum Wuppertal, Medizinische Klinik 1 | Wuppertal | 42283 | Germany |
| FG001 | Control Arm | Cetuximab infusion: initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle; Paclitaxel infusion: 200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles Carboplatin infusion: dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles. Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor. |
| Discontinued |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population comprised all randomized participants who received any amount of Imprime PGG, cetuximab, paclitaxel or carboplatin.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Imprime PGG Arm | Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin |
| BG001 | Control Arm | Cetuximab + Paclitaxel/Carboplatin |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| ECOG | ECOG Score: runs from 0 to 5, with 0 denoting perfect health and 5 death. 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction) 1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work) | Number | participants |
| |||||||||||||||
| Baseline Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Baseline Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Baseline Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Time from Initial Tumor Diagnosis | Mean | Standard Deviation | months |
| |||||||||||||||
| Prior Cancer Treatment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review | Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. | The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0. | Posted | Number | participants | From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) in Each Study Arm Based on the Safety Population | Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated. Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates. | The safety population comprised all randomized subjects who received any amount of Imprime PGG, cetuximab, paclitaxel or carboplatin. | Posted | Median | 95% Confidence Interval | months | From the time of randomization to death, subject being lost to follow-up or study completion |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review | The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. | The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0. | Posted | Number | participants | From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review | The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. | The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0. | Posted | Number | participants | From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review | The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. | The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0. | Posted | Median | 95% Confidence Interval | months | From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review | Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator. If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date. | The primary efficacy population comprised all randomized subjects who had no major violations of inclusion/exclusion or significant protocol violations & received any amount of cetuximab, paclitaxel or carboplatin therapy or Imprime PGG, & had an evaluable baseline scan & at least one evaluable post-baseline response based on modified RECIST v1.0. | Posted | Median | 95% Confidence Interval | months | From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of investigational product to the discontinuation of study plus 30 days after the last dose of study drug or until the subject began alternative therapy.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imprime PGG Arm | Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin | 37 | 59 | 59 | 59 | ||
| EG001 | Control Arm | Cetuximab + Paclitaxel/Carboplatin | 12 | 29 | 29 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vascular occulsion | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Lowe, Vice President, Clinical Development | Biothera | 651-256-4653 | jlowe@biothera.com |
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D056831 | Coordination Complexes |
Not provided
Not provided
| Male |
|
| Black |
|
| Other |
|
| Germany |
|
| Score = 1 |
|
| Missing |
|
| Surgery |
|
| Chemotherapy |
|
|
Cetuximab + Paclitaxel/Carboplatin
|
|
| OG001 |
| Control Arm |
Cetuximab + Paclitaxel/Carboplatin |
|
|
| Control Arm |
Cetuximab + Paclitaxel/Carboplatin |
|
|
| Control Arm |
Cetuximab + Paclitaxel/Carboplatin |
|
|