Trial · NCT01373164
A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer
NCT01373164, Phase 1, Phase 2, Completed, Eli Lilly and Company; results first posted 2018-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer. Trials, record NCT01373164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01373164
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Metastatic Cancer and Advanced or Metastatic Unresectable Pancreatic Cancer
- NCT number
- NCT01373164
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 170 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Neoplasms, Neoplasm Metastasis, Pancreatic Cancer
- Interventions
- Galunisertib, Gemcitabine, Placebo
- First posted
- 2011-06-14
- Last updated
- 2018-05-16
- Results first posted
- 2018-05-16
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Recommended Phase 2 Dose | Time of first phase 1b dose until time of last phase 1b dose (up to 1 year) | 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. |
| Primary | Phase 2: Overall Survival (OS) | Baseline to date of death from any cause (up to 2 years) | 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. |
| Secondary | 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) | Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) | 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. |
| Secondary | Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss) | Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) | 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. |
| Secondary | Phase 1b: Number of Participants With Tumor Response | Baseline to end of Phase 1b (up to 1 year) | 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. |
| Secondary | Phase 2: Progression Free Survival (PFS) | Baseline to first date of progressive disease or death due to any cause (up to 2 years) | 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. |
| Secondary | Phase 2: Percentage Change From Baseline in Tumor Size (CTS) | Baseline, end of Cycle 2 (up to 56 days) | 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. |
| Secondary | Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR]) | Baseline to measured progressive disease (up to 2 years) | 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. |
| Secondary | Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) | Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) | 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. |
| Secondary | Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib | Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Recommended Phase 2 Dose | Time of first phase 1b dose until time of last phase 1b dose (up to 1 year) | Phase 1b: All participants who received at least one dose of study drug. | milligrams (mg) | NUMBER |
| PRIMARY | Phase 2: Overall Survival (OS) | Baseline to date of death from any cause (up to 2 years) | All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 20 and Placebo + Gemcitabine = 4. | Months | MEDIAN |
| SECONDARY | 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) | Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) | Phase 1b: All participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data. | nanogram*hour per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss) | Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) | Phase 1b: All participants who received at least one dose of study drug and had evaluable PK data. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Phase 1b: Number of Participants With Tumor Response | Baseline to end of Phase 1b (up to 1 year) | Phase 1b: All participants who received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Phase 2: Progression Free Survival (PFS) | Baseline to first date of progressive disease or death due to any cause (up to 2 years) | All randomized participants who received at least one dose of study drug and had baseline \& at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 21 and Placebo + Gemcitabine = 11. | Months | MEDIAN |
| SECONDARY | Phase 2: Percentage Change From Baseline in Tumor Size (CTS) | Baseline, end of Cycle 2 (up to 56 days) | All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for change in tumor size. | Percent change in tumor size | GEOMETRIC_MEAN |
| SECONDARY | Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR]) | Baseline to measured progressive disease (up to 2 years) | All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for ORR. | Percentage of Participants | NUMBER |
| SECONDARY | Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) | Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) | All randomized participants who received at least 1 dose of study drug with evaluable PK data. | mg*h/L | MEAN |
| SECONDARY | Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib | Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16) | All randomized participants who received at least 1 dose of study drug with evaluable PK data. | ng/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Recommended Phase 2 Dose | Phase 1b Participants | 300 | milligrams (mg) | ||
| Phase 2: Overall Survival (OS) | Phase 2: 300 mg Galunisertib + Gemcitabine | 8.9 | 95% Confidence Interval 7.3 to 11.1 | Months | |
| Phase 2: Overall Survival (OS) | Phase 2: Placebo + Gemcitabine | 7.1 | 95% Confidence Interval 5.8 to 9.0 | Months | |
| 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) | Phase 1b: 80 mg Galunisertib + Gemcitabine | AUC(0-24) | 2530 | Geometric Coefficient of Variation 116 | nanogram*hour per milliliter (ng*h/mL) |
| 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) | Phase 1b: 160 mg Galunisertib + Gemcitabine | AUC(0-24) | NA | Geometric Coefficient of Variation NA | nanogram*hour per milliliter (ng*h/mL) |
| 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) | Phase 1b: 300 mg Galunisertib + Gemcitabine | AUC(0-24) | 9090 | Geometric Coefficient of Variation 27 | nanogram*hour per milliliter (ng*h/mL) |
| 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) | Phase 1b: 80 mg Galunisertib + Gemcitabine | AUC(0-∞) | 2740 | Geometric Coefficient of Variation 117 | nanogram*hour per milliliter (ng*h/mL) |
| 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) | Phase 1b: 160 mg Galunisertib + Gemcitabine | AUC(0-∞) | NA | Geometric Coefficient of Variation NA | nanogram*hour per milliliter (ng*h/mL) |
| 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) | Phase 1b: 300 mg Galunisertib + Gemcitabine | AUC(0-∞) | 10600 | Geometric Coefficient of Variation 10 | nanogram*hour per milliliter (ng*h/mL) |
| Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss) | Phase 1b: 80 mg Galunisertib + Gemcitabine | 385 | Geometric Coefficient of Variation 101 | nanogram per milliliter (ng/mL) |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b: 80 mg (Milligrams) Galunisertib + Gemcitabine | 5 | |
| Overall Study | STARTED | Phase 1b: 160 mg Galunisertib + Gemcitabine | 4 | |
| Overall Study | STARTED | Phase 1b: 300 mg Galunisertib + Gemcitabine | 5 | |
| Overall Study | STARTED | Phase 2: 300 mg Galunisertib + Gemcitabine | 104 | |
| Overall Study | STARTED | Phase 2: Placebo + Gemcitabine | 52 | |
| Overall Study | Received at Least One Dose | Phase 1b: 80 mg (Milligrams) Galunisertib + Gemcitabine | 5 | |
| Overall Study | Received at Least One Dose | Phase 1b: 160 mg Galunisertib + Gemcitabine | 4 | |
| Overall Study | Received at Least One Dose | Phase 1b: 300 mg Galunisertib + Gemcitabine | 5 | |
| Overall Study | Received at Least One Dose | Phase 2: 300 mg Galunisertib + Gemcitabine | 103 | |
| Overall Study | Received at Least One Dose | Phase 2: Placebo + Gemcitabine | 52 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events955
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: 80 mg Galunisertib + Gemcitabine | 3 | 5 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: 160 mg Galunisertib + Gemcitabine | 3 | 4 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: 300 mg Galunisertib + Gemcitabine | 3 | 5 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: 300 mg Galunisertib + Gemcitabine | 44 | 103 | 95 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Placebo + Gemcitabine | 28 | 52 | 35 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 1b: 80 mg Galunisertib + Gemcitabine | 0 | 5 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 1b: 160 mg Galunisertib + Gemcitabine | 1 | 4 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 1b: 300 mg Galunisertib + Gemcitabine | 0 | 5 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 2: 300 mg Galunisertib + Gemcitabine | 0 | 103 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 2: Placebo + Gemcitabine | 0 | 52 | 0 |
1 to 10 of 955Source ClinicalTrials.gov
See all 955 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b: 80 mg Galunisertib + Gemcitabine | ||
| Total, all-cause mortality | Phase 1b: 160 mg Galunisertib + Gemcitabine | ||
| Total, all-cause mortality | Phase 1b: 300 mg Galunisertib + Gemcitabine | ||
| Total, all-cause mortality | Phase 2: 300 mg Galunisertib + Gemcitabine | ||
| Total, all-cause mortality | Phase 2: Placebo + Gemcitabine | ||
| Total, other adverse events | Phase 1b: 80 mg Galunisertib + Gemcitabine | 5 | 5 |
| Total, other adverse events | Phase 1b: 160 mg Galunisertib + Gemcitabine | 4 | 4 |
| Total, other adverse events | Phase 1b: 300 mg Galunisertib + Gemcitabine | 5 | 5 |
| Total, other adverse events | Phase 2: 300 mg Galunisertib + Gemcitabine | 100 | 103 |
| Total, other adverse events | Phase 2: Placebo + Gemcitabine | 49 | 52 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01373164
GET https://conductscience.org/api/trials/v1/NCT01373164/results?page=2