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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004605-29 | EudraCT Number |
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This open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib + Gemcitabine | Experimental | Participants will receive erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported. | Up to approximately 40 months (assessed continuously during treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores | The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 ("no/not at all") to 4 ("very much") where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 ("very poor") to 7 ("excellent") where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bari | Apulia | 70124 | Italy | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib + Gemcitabine | Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population: All participants who received at least one dose of erlotinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib + Gemcitabine | Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported. | Safety Population | Posted | Number | percentage of participants | Up to approximately 40 months (assessed continuously during treatment) |
|
Up to approximately 40 months (assessed continuously during treatment)
Analysis Population Description: Safety Population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib + Gemcitabine | Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Gemcitabine | Drug | Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle. |
|
| Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study) |
| Percentage of Participants Who Died | The percentage of participants who died from any cause was reported to the nearest integer. | Up to approximately 40 months (assessed continuously through end of study) |
| Overall Survival (OS) | OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months. | Up to approximately 40 months (assessed continuously through end of study) |
| Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) | Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer. | Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) |
| Progression-Free Survival (PFS) According to RECIST | Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months. | Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) |
| Naples |
| Campania |
| 80131 |
| Italy |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Pordenone | Friuli Venezia Giulia | 33170 | Italy |
| Rome | Lazio | 00144 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Catania | Sicily | 95126 | Italy |
| Pisa | Tuscany | 56100 | Italy |
| Perugia | Umbria | 06156 | Italy |
| Cona (Ferrara) | Veneto | 44124 | Italy |
| Verona | Veneto | 37126 | Italy |
| Withdrawal by Subject |
|
| Death |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores | The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 ("no/not at all") to 4 ("very much") where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 ("very poor") to 7 ("excellent") where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available. | Safety Population. The "Number of Participants Analyzed" reflects the total number of participants who contributed to the endpoint. The number of responses for each questionnaire item combined across all assessments (n) is shown in the table. | Posted | Mean | Standard Deviation | units on a scale | Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study) |
|
|
|
| Secondary | Percentage of Participants Who Died | The percentage of participants who died from any cause was reported to the nearest integer. | Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint. | Posted | Number | percentage of participants | Up to approximately 40 months (assessed continuously through end of study) |
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months. | Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint. | Posted | Median | 95% Confidence Interval | months | Up to approximately 40 months (assessed continuously through end of study) |
|
|
|
| Secondary | Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) | Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer. | Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint. | Posted | Number | percentage of participants | Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) |
|
|
|
| Secondary | Progression-Free Survival (PFS) According to RECIST | Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months. | Safety Population. The "Number of Participants Analyzed" reflects the number of participants who contributed to the endpoint. | Posted | Median | 95% Confidence Interval | months | Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study) |
|
|
|
| 35 |
| 80 |
| 44 |
| 80 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Intestinal perforation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Pancreatic carcinoma | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Disease progression | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Ill-defined disorder | General disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.0) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA (9.0) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Melaena | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
|
| Q4: Need to say in bed or chair (n=255) |
|
| Q5: Need help in daily activities (n=259) |
|
| Q6: Limited in doing work/daily activities (n=257) |
|
| Q7: Limited in pursuing hobbies (n=255) |
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| Q8: Short of breath (n=258) |
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| Q9: Pain (n=257) |
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| Q10: Need to rest (n=255) |
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| Q11: Trouble sleeping (n=257) |
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| Q12: Felt weak (n=255) |
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| Q13: Lacked appetite (n=257) |
|
| Q14: Felt nauseated (n=257) |
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| Q15: Vomited (n=259) |
|
| Q16: Constipated (n=259) |
|
| Q17: Diarrhea (n=259) |
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| Q18: Tired (n=255) |
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| Q19: Pain interference with daily activity (n=256) |
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| Q20: Difficulty concentrating (n=257) |
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| Q21: Felt tense (n=256) |
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| Q22: Worried (n=253) |
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| Q23: Felt irritable (n=258) |
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| Q24: Felt depressed (n=258) |
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| Q25: Difficulty remembering things (n=257) |
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| Q26: Interference with family life (n=257) |
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| Q27: Interference with social activities (n=257) |
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| Q28: Financial difficulties (n=258) |
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| Q29: Overall health (n=255) |
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| Q30: Overall quality of life (n=255) |
|