A Phase 1/2 interventional study of Galunisertib and Gemcitabine in Neoplasms, Neoplasm Metastasis and Pancreatic Cancer, sponsored by Eli Lilly and Company. Completed at 24 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-16.
Sponsored by Eli Lilly and Company · Phase 1/2, Interventional, and Treatment
Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy
Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 170 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: For both Phase 1b and Phase 2 (unless specified in the following), patients are eligible to be included in the study only if they meet all of the following criteria:
For Phase 1b:
For Phase 1b and Phase 2:
For Phase 2:
Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria:
Cohort 1: 40 mg Galunisertib was administered orally twice daily (BID) for 14 days followed by 14 days of rest (28 day cycle). Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
Drug: Galunisertib · Drug: Gemcitabine
Cohort 2: 80 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle). Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
Drug: Galunisertib · Drug: Gemcitabine
Cohort 3: 150 mg Galunisertib was administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle). Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
Drug: Galunisertib · Drug: Gemcitabine
Galunisertib recommended dose (300 mg) determined from phase 1, administered orally twice daily for 14 days followed by 14 days of rest (28 day cycle). Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
Drug: Galunisertib · Drug: Gemcitabine
Placebo administered orally twice daily for 14 days followed 14 days of rest (28 day cycle). Gemcitabine at a dose of 1000 mg/m\^2 was administered intravenously once per week for 7 weeks followed by 1 week of rest and then once per week for 3 weeks of every 4 weeks.
Drug: Gemcitabine · Drug: Placebo
Administered orally
Also known as: LY2157299
Administered intravenously
Also known as: Gemzar, LY188011
Administered orally
Phase 1b: Recommended Phase 2 Dose
The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from Phase 1b.
Time frame: Time of first phase 1b dose until time of last phase 1b dose (up to 1 year)
Phase 2: Overall Survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
Time frame: Baseline to date of death from any cause (up to 2 years)
Phase 1b: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 24 Hours (AUC[0-24], ss) and Time Zero to Infinity (AUC[0-∞], ss)
AUC\[0-24h\] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute. AUC0-infinity will take 48h and extrapolation beyond this in addition to earlier time points to be calculated. All mentioned time points are used to calculate the two AUCs.
Time frame: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)
Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss)
Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.
Time frame: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)
Phase 1b: Number of Participants With Tumor Response
Response was defined using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.
Time frame: Baseline to end of Phase 1b (up to 1 year)
Phase 2: Progression Free Survival (PFS)
PFS is defined as the date of randomization to the first date of progression of disease or of death from any cause. For each participant who is not known to have died or to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, PFS will be censored at the date of last prior contact. PFS will be calculated and analyzed twice: (1) including clinical progressions of disease not based on lesion measurements, and (2) excluding clinical progressions. Progression Disease (PD) was defined as having at least a 25% increase in the sum of the longest diameter of target lesions.
Time frame: Baseline to first date of progressive disease or death due to any cause (up to 2 years)
Phase 2: Percentage Change From Baseline in Tumor Size (CTS)
Change in tumor size is defined as the maximum percent change from baseline in the sum of target lesions. Change was assessed in each participant using radiographic imaging.
Time frame: Baseline, end of Cycle 2 (up to 56 days)
Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Time frame: Baseline to measured progressive disease (up to 2 years)
Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])
AUC\[0-24\] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute.
Time frame: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)
Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib
Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.
Time frame: Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)
Phase 2: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) at Study Completion
The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions that included assessing average pain in the past 24 hours.
Time frame: Baseline, study treatment completion (up to 1 year)
Phase 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA19-9) Level at First Study Completion Follow-up
Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen, and has been used as a tumor marker. The outcome measure is the median, minimum and maximum values from participants who had samples collected at baseline and at follow-up
Time frame: Baseline, study treatment completion after first follow up visit (up to 1 year)
| Milestone | Phase 1b: 80 mg (Milligrams) Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine |
|---|---|---|---|---|---|
| Started | 5 | 4 | 5 | 104 | 52 |
| Received at least one dose | 5 | 4 | 5 | 103 | 52 |
| Completed | 5 | 3 | 4 | 92 | 50 |
| Not completed | 0 | 1 | 1 | 12 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 10 | 2 |
The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from Phase 1b.
| milligrams (mg) | Phase 1b Participants |
|---|---|
| Phase 1b: Recommended Phase 2 Dose | 300 |
Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.
| Months | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine |
|---|---|---|
| Phase 2: Overall Survival (OS) | 8.9 (7.3 to 11.1) | 7.1 (5.8 to 9.0) |
AUC\[0-24h\] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute. AUC0-infinity will take 48h and extrapolation beyond this in addition to earlier time points to be calculated. All mentioned time points are used to calculate the two AUCs.
| nanogram*hour per milliliter (ng*h/mL) | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine |
|---|---|---|---|
| AUC(0-24) | 2530 ± 116 | NA ± NA | 9090 ± 27 |
| AUC(0-∞) | 2740 ± 117 | NA ± NA | 10600 ± 10 |
Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.
| nanogram per milliliter (ng/mL) | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine |
|---|---|---|---|
| Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss) | 385 ± 101 | NA ± NA | 1050 ± 39 |
Response was defined using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.
| Participants | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine |
|---|---|---|---|
| Progressive Disease (PD) | 3 | 1 | 2 |
| Stable Disease (SD) | 1 | 2 | 2 |
| Partial Response (PR) | 0 | 1 | 0 |
| Non-Complete Response/Non-Progressive Disease (NC) | 0 | 0 | 1 |
| Not Assessed (NA) | 1 | 0 | 0 |
PFS is defined as the date of randomization to the first date of progression of disease or of death from any cause. For each participant who is not known to have died or to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, PFS will be censored at the date of last prior contact. PFS will be calculated and analyzed twice: (1) including clinical progressions of disease not based on lesion measurements, and (2) excluding clinical progressions. Progression Disease (PD) was defined as having at least a 25% increase in the sum of the longest diameter of target lesions.
| Months | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine |
|---|---|---|
| Phase 2: Progression Free Survival (PFS) | 4.11 (2.66 to 5.42) | 2.86 (1.94 to 3.75) |
Change in tumor size is defined as the maximum percent change from baseline in the sum of target lesions. Change was assessed in each participant using radiographic imaging.
| Percent change in tumor size | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine |
|---|---|---|
| Independent Assessor 1 | 0.95 (0.90 to 1.01) | 0.92 (0.87 to 0.98) |
| Independent Assessor 2 | 1.03 (0.95 to 1.11) | 0.98 (0.92 to 1.05) |
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
| Percentage of Participants | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine |
|---|---|---|
| Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR]) | 10.6 (5.4 to 18.1) | 3.8 (0.5 to 13.2) |
AUC\[0-24\] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute.
| mg*h/L | Phase 2: 300 mg Galunisertib + Gemcitabine |
|---|---|
| Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) | 5.56 (3.82 to 7.91) |
Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.
| ng/mL | Phase 2: 300 mg Galunisertib + Gemcitabine |
|---|---|
| Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib | 904 (668 to 1194) |
The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions that included assessing average pain in the past 24 hours.
| Units on a scale | Phase 2: 300 mg Galunisertib + Gemcitabine | Placebo+Gemcitabine |
|---|---|---|
| Phase 2: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) at Study Completion | 2.54 ± 2.53 | 1.50 ± 2.12 |
Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen, and has been used as a tumor marker. The outcome measure is the median, minimum and maximum values from participants who had samples collected at baseline and at follow-up
| Units/Milliliter (U/mL) | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine |
|---|---|---|
| Phase 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA19-9) Level at First Study Completion Follow-up | 32.7 (-93.8 to 3636.3) | -33.3 (-98.1 to 2460.9) |
Collected over Up to 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1b: 80 mg Galunisertib + Gemcitabine | — | 1/5 (20%) | 5/5 (100%) |
| Phase 1b: 160 mg Galunisertib + Gemcitabine | — | 1/4 (25%) | 4/4 (100%) |
| Phase 1b: 300 mg Galunisertib + Gemcitabine | — | 2/5 (40%) | 5/5 (100%) |
| Phase 2: 300 mg Galunisertib + Gemcitabine | — | 56/103 (54.4%) | 100/103 (97.1%) |
| Phase 2: Placebo + Gemcitabine | — | 26/52 (50%) | 49/52 (94.2%) |
| Event | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine |
|---|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 0/5 | 1/4 | 0/5 | 5/103 | 1/52 |
| Large intestinal obstructionGastrointestinal disorders | 1/5 | 0/4 | 0/5 | 0/103 | 0/52 |
| PyrexiaGeneral disorders | 0/5 | 0/4 | 1/5 | 4/103 | 3/52 |
| RhabdomyolysisMusculoskeletal and connective tissue disorders | 0/5 | 0/4 | 1/5 | 0/103 | 0/52 |
| Malignant ascitesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/5 | 0/4 | 0/5 | 0/103 | 0/52 |
| Intestinal obstructionGastrointestinal disorders | 0/5 | 0/4 | 0/5 | 1/103 | 3/52 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/5 | 0/4 | 0/5 | 5/103 | 1/52 |
| VomitingGastrointestinal disorders | 0/5 | 0/4 | 0/5 | 4/103 | 2/52 |
| CholangitisHepatobiliary disorders | 0/5 | 0/4 | 0/5 | 4/103 | 2/52 |
| NauseaGastrointestinal disorders | 0/5 | 0/4 | 0/5 | 2/103 | 2/52 |
| Event | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 2/5 | 4/4 | 4/5 | 39/103 | 17/52 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/5 | 1/4 | 1/5 | 29/103 | 13/52 |
| AnaemiaBlood and lymphatic system disorders | 3/5 | 3/4 | 3/5 | 44/103 | 28/52 |
| VomitingGastrointestinal disorders | 3/5 | 3/4 | 3/5 | 27/103 | 19/52 |
| PyrexiaGeneral disorders | 1/5 | 3/4 | 2/5 | 38/103 | 11/52 |
| NeutropeniaBlood and lymphatic system disorders | 3/5 | 2/4 | 3/5 | 34/103 | 17/52 |
| AstheniaGeneral disorders | 0/5 | 1/4 | 3/5 | 36/103 | 17/52 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 3/5 | 1/4 | 1/5 | 4/103 | 1/52 |
| HeadacheNervous system disorders | 3/5 | 1/4 | 1/5 | 6/103 | 6/52 |
| ConstipationGastrointestinal disorders | 2/5 | 2/4 | 1/5 | 30/103 | 15/52 |
All participants who received at least one dose of study drug.
| Age, Continuous(Years) | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| Mean | 63.2 ± 12.9 | 63.8 ± 9.0 | 56.6 ± 9.2 | 67.3 ± 8.2 | 66.3 ± 8.9 | 63.5 ± 9.7 |
| Sex: Female, Male(Participants) | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 3 | 3 | 46 | 24 | 76 |
| Male | 5 | 1 | 2 | 57 | 28 | 93 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 5 | 4 | 4 | 37 | 18 | 68 |
| Unknown or Not Reported | 0 | 0 | 0 | 66 | 34 | 100 |
| Race (NIH/OMB)(Participants) | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 0 | 0 | 0 | 2 |
| White | 3 | 4 | 5 | 95 | 50 | 157 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 8 | 2 | 10 |
| Region of Enrollment(Participants) | Phase 1b: 80 mg Galunisertib + Gemcitabine | Phase 1b: 160 mg Galunisertib + Gemcitabine | Phase 1b: 300 mg Galunisertib + Gemcitabine | Phase 2: 300 mg Galunisertib + Gemcitabine | Phase 2: Placebo + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| Belgium | 0 | 0 | 0 | 4 | 2 | 6 |
| United States | 5 | 2 | 1 | 7 | 4 | 19 |
| Italy | 0 | 0 | 0 | 23 | 10 | 33 |
| France | 0 | 0 | 0 | 21 | 9 | 30 |
| Germany | 0 | 0 | 0 | 22 | 14 | 36 |
| Spain | 0 | 2 | 4 | 26 | 13 | 45 |
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