Locally Advanced Pancreatic Cancer, Metastatic Pancreas Cancer, Pancreatic Adenocarcinoma
Conditions
Keywords
FOLFIRINOX, 5-Fluorouracil, folinic acid, irinotecan, oxaliplatin, Gemcitabine
Brief summary
The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.
Detailed description
The objective of the study was to assess the safety and efficacy of a combination therapy of EndoTAG-1 plus gemcitabine vs. gemcitabine monotherapy in patients with locally advanced and/or metastatic adenocarcinoma of the pancreas eligible for second-line therapy after failing first line therapy with FOLFIRINOX
Interventions
DRUGEndoTAG-1
twice weekly
DRUGGemcitabine
once weekly
Sponsors
SynCore Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Written informed consent 3. Histologically or cytologically confirmed adenocarcinoma of the pancreas 4. Metastatic or locally advanced disease that is considered unresectable 5. Measurable / assessable disease according to RECIST v.1.1 6. Documented disease progression on first line FOLFIRINOX 7. Negative pregnancy test 8. Both male and female patients and their partners of childbearing potential must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives \[male condom, female condom, or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\], or one of the following methods of birth control (intrauterine devices, tubal sterilization or vasectomy) or must practice complete abstinence from intercourse of reproductive potential during the course of the study and for 90 days after last treatment (excluding women who are not of childbearing potential and men who have been sterilized). 9. ECOG performance status 0 or 1
Exclusion criteria
1. Cardiovascular disease, New York Heart Association (NYHA) III or IV 2. History of severe supraventricular or ventricular arrhythmia 3. History of coagulation or bleeding disorder 4. History of acute myocardial infarction within 6 months before randomization 5. History of congestive heart failure 6. Acute or chronic inflammation (autoimmune or infectious) 7. Significant active/unstable non-malignant disease likely to interfere with study assessments 8. Laboratory tests (hematology, chemistry) outside specified limits: 1. WBC ≤ 3 x 10³/mm³ 2. ANC ≤ 1.5 x 10³/mm³ 3. Platelets ≤ 100.000/mm³ 4. Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l) 5. aPTT \> 1.5 x ULN 6. Serum creatinine \> 2.0 mg/dl (\> 176.8 μmol/l) 7. AST and/or ALT \> 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT \> 5 x ULN 8. Alkaline phosphatase \> 2.5 x ULN 9. Total bilirubin \> 2 x ULN 10. Albumin \< 2.5 g/dL 9. Clinically significant ascites 10. Any anti-tumor treatment (except FOLFIRINOX as the first-line therapy) for pancreatic adenocarcinoma before enrollment. Note: Patients who have undergone surgical interventions for pancreatic adenocarcinoma will be eligible. 11. Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field 12. Major surgery \< 4 weeks prior to enrollment 13. Pregnant or nursing 14. Investigational medicinal product \< 4 weeks of enrollment 15. Documented HIV history 16. Active hepatitis B infection requiring acute therapy Note: Subjects infected by the hepatitis B virus will be eligible for the study if they have no signs of hepatic decompensation and meet the liver function tests eligibility criteria. 17. Known hypersensitivity to any component of the EndoTAG-1 and/or gemcitabine formulations 18. History of malignancy other than pancreatic cancer \< 3 years prior to enrollment, except nonmelanoma skin cancer or carcinoma in situ of the cervix treated locally 19. Vulnerable populations (e.g. subjects unable to understand and give voluntary informed consent)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment) | The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment) | The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning first observation of progressive disease, compared to number of subjects censored at the time of analysis. |
| Percentage of Subjects With Objective Response | Up to approximately 33.5 months (assessed continuously during treatment) | Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1. |
| Duration of Response | From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause. | Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30. |
| Percentage of Subjects With Disease Control According to RECIST v.1.1 | Up to approximately 33.5 months (assessed continuously during treatment) | Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1 |
| Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate | Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course) | Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowled habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues. |
| Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30): included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/ vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score = better level of functioning or greater degree of symptoms. Change from baseline = Cycle/day score minus baseline score. |
Countries
France, Hungary, Israel, Russia, South Korea, Taiwan, United States
Participant flow
Recruitment details
218 subjects were enrolled between October 2018 and July 2020.
Participants by arm
| Arm | Count |
|---|---|
| EndoTAG-1 and Gemcitabine EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
EndoTAG-1: twice weekly
Gemcitabine: once weekly | 108 |
| Gemcitabine Monotherapy Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.
Gemcitabine: once weekly | 110 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 90 | 84 |
| Overall Study | e.g. Sponsor Decision, General Deterioration... | 6 | 4 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 12 |
Baseline characteristics
| Characteristic | Gemcitabine Monotherapy | EndoTAG-1 and Gemcitabine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 39 Participants | 77 Participants |
| Age, Categorical Between 18 and 65 years | 72 Participants | 69 Participants | 141 Participants |
| Age, Continuous | 61.7 years STANDARD_DEVIATION 9.68 | 60.7 years STANDARD_DEVIATION 9.98 | 61.2 years STANDARD_DEVIATION 9.82 |
| ECOG Performance at Randomization 0 | 48 Participants | 49 Participants | 97 Participants |
| ECOG Performance at Randomization 1 | 62 Participants | 59 Participants | 121 Participants |
| Extent of Disease at Randomization Locally Advanced | 15 Participants | 14 Participants | 29 Participants |
| Extent of Disease at Randomization Metastatic | 95 Participants | 94 Participants | 189 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 31 Participants | 35 Participants | 66 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 15 Participants | 33 Participants |
| Race (NIH/OMB) White | 59 Participants | 56 Participants | 115 Participants |
| Region of Enrollment France | 21 participants | 20 participants | 41 participants |
| Region of Enrollment Hungary | 17 participants | 15 participants | 32 participants |
| Region of Enrollment Israel | 6 participants | 7 participants | 13 participants |
| Region of Enrollment Russia | 27 participants | 26 participants | 53 participants |
| Region of Enrollment South Korea | 18 participants | 13 participants | 31 participants |
| Region of Enrollment Taiwan | 13 participants | 21 participants | 34 participants |
| Region of Enrollment United States | 8 participants | 6 participants | 14 participants |
| Sex: Female, Male Female | 50 Participants | 38 Participants | 88 Participants |
| Sex: Female, Male Male | 60 Participants | 70 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 91 / 108 | 85 / 110 |
| other Total, other adverse events | 101 / 102 | 100 / 102 |
| serious Total, serious adverse events | 52 / 102 | 48 / 102 |
Outcome results
Primary
Overall Survival
The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis.
Time frame: From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EndoTAG-1 and Gemcitabine | Overall Survival | 226 days |
| Gemcitabine Monotherapy | Overall Survival | 209 days |
p-value: 0.6647Log Rank
Secondary
Duration of Response
Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30.
Time frame: From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoTAG-1 and Gemcitabine | Duration of Response | 5.8 Months | Standard Deviation 2.62 |
| Gemcitabine Monotherapy | Duration of Response | 9.1 Months | Standard Deviation 6.97 |
Secondary
Percentage of Subjects With Disease Control According to RECIST v.1.1
Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1
Time frame: Up to approximately 33.5 months (assessed continuously during treatment)
Population: There were 12 subjects in the EndoTAG-1 treated group and 22 subjects in the Gemcitabine Monotherapy group that were not included in analysis due to missing records.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoTAG-1 and Gemcitabine | Percentage of Subjects With Disease Control According to RECIST v.1.1 | 57 Participants |
| Gemcitabine Monotherapy | Percentage of Subjects With Disease Control According to RECIST v.1.1 | 43 Participants |
p-value: 0.1002Regression, Logistic
Secondary
Percentage of Subjects With Objective Response
Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1.
Time frame: Up to approximately 33.5 months (assessed continuously during treatment)
Population: Of the 108 subjects that received EndoTAG-1 and Gemcitabine, 11 subjects (11.46%, 11/96) presented with a complete or partial response. There were 6 subjects (6.82%, 6/88) that received Gemcitabine Monotherapy considered to have an objective response. For 12 subjects in the EndoTAG-1 group and 22 subjects in the Gemcitabine Monotherapy group, objective response assessments were missing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoTAG-1 and Gemcitabine | Percentage of Subjects With Objective Response | 11 Participants |
| Gemcitabine Monotherapy | Percentage of Subjects With Objective Response | 6 Participants |
p-value: 0.2632Regression, Logistic
Secondary
Progression Free Survival (PFS)
The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning first observation of progressive disease, compared to number of subjects censored at the time of analysis.
Time frame: From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EndoTAG-1 and Gemcitabine | Progression Free Survival (PFS) | 113 days |
| Gemcitabine Monotherapy | Progression Free Survival (PFS) | 110 days |
p-value: 0.4345Log Rank
Secondary
Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate
Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments.
Time frame: Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoTAG-1 and Gemcitabine | Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate | 2 Participants |
| Gemcitabine Monotherapy | Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate | 2 Participants |
p-value: 0.9882Regression, Logistic
Other Pre-specified
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30): included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/ vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score = better level of functioning or greater degree of symptoms. Change from baseline = Cycle/day score minus baseline score.
Time frame: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))
Population: Some missing data (Change from baseline is based on subjects with paired values.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social | 0.6 score on a scale | Standard Deviation 1.7 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Cognitive | 0.5 score on a scale | Standard Deviation 1.2 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Symptom scales | 2.6 score on a scale | Standard Deviation 4.4 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Emotional | 1.2 score on a scale | Standard Deviation 2.6 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue | 1.5 score on a scale | Standard Deviation 2.2 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Global health QoL | -1.6 score on a scale | Standard Deviation 2.7 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain | 0.7 score on a scale | Standard Deviation 1.8 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Side effect scales | 1.3 score on a scale | Standard Deviation 2.6 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea/vomiting | 0.4 score on a scale | Standard Deviation 1.5 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Appetite loss | 0.5 score on a scale | Standard Deviation 1.1 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea | 0.5 score on a scale | Standard Deviation 0.9 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical | 2.0 score on a scale | Standard Deviation 3.1 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Functional scales | 5.4 score on a scale | Standard Deviation 8.2 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia | 0.0 score on a scale | Standard Deviation 0.9 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation/diarrhea | 0.4 score on a scale | Standard Deviation 1.2 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role | 1.1 score on a scale | Standard Deviation 1.7 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation/diarrhea | 0.4 score on a scale | Standard Deviation 1.2 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social | 0.9 score on a scale | Standard Deviation 1.6 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia | 0.2 score on a scale | Standard Deviation 1.2 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Global health QoL | -2.0 score on a scale | Standard Deviation 2.7 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Functional scales | 6.9 score on a scale | Standard Deviation 9 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Symptom scales | 2.6 score on a scale | Standard Deviation 4.5 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Side effect scales | 1.4 score on a scale | Standard Deviation 3 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical | 2.4 score on a scale | Standard Deviation 3.4 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role | 1.4 score on a scale | Standard Deviation 1.9 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Cognitive | 0.6 score on a scale | Standard Deviation 1.5 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue | 1.4 score on a scale | Standard Deviation 2.1 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain | 0.9 score on a scale | Standard Deviation 2 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea/vomiting | 0.2 score on a scale | Standard Deviation 1.5 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea | 0.6 score on a scale | Standard Deviation 0.9 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Appetite loss | 0.3 score on a scale | Standard Deviation 0.9 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Emotional | 1.6 score on a scale | Standard Deviation 3 |
Other Pre-specified
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowled habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.
Time frame: Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT))
Population: Some missing data (Change from baseline is based on subjects with paired values.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body image | 0.6 score on a scale | Standard Deviation 1.8 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic pain | 1.0 score on a scale | Standard Deviation 3 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive | 0.6 score on a scale | Standard Deviation 2.1 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered bowel habit | 0.5 score on a scale | Standard Deviation 1.8 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic | 0.0 score on a scale | Standard Deviation 0.9 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Health care satisfaction | 0.8 score on a scale | Standard Deviation 1.6 |
| EndoTAG-1 and Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality | -0.1 score on a scale | Standard Deviation 2.4 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Health care satisfaction | 0.4 score on a scale | Standard Deviation 1.6 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic | 0.0 score on a scale | Standard Deviation 1.1 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic pain | 1.7 score on a scale | Standard Deviation 3.2 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body image | 0.7 score on a scale | Standard Deviation 1.9 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive | 0.9 score on a scale | Standard Deviation 1.6 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality | 0.8 score on a scale | Standard Deviation 2.5 |
| Gemcitabine Monotherapy | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered bowel habit | -0.1 score on a scale | Standard Deviation 1.5 |