A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02734160 |
Recruitment Status :
Completed
First Posted : April 12, 2016
Last Update Posted : August 5, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Pancreatic Cancer | Drug: Galunisertib Drug: Durvalumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b Dose-Escalation and Cohort-Expansion Study of the Safety, Tolerability, and Efficacy of a Novel Transforming Growth Factor-β Receptor I Kinase Inhibitor (Galunisertib) Administered in Combination With the Anti-PD-L1 Antibody Durvalumab (MEDI4736) in Recurrent or Refractory Metastatic Pancreatic Cancer |
Actual Study Start Date : | June 15, 2016 |
Actual Primary Completion Date : | August 2, 2018 |
Actual Study Completion Date : | April 17, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Galunisertib + Durvalumab
(Dose Escalation and Cohort Expansion) Galunisertib administered orally in combination with durvalumab administered intravenously (IV).
|
Drug: Galunisertib
Administered orally
Other Name: LY2157299 Drug: Durvalumab Administered IV
Other Name: MEDI4736 |
- Number of Participants with Galunisertib in Combination with Durvalumab Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 Days) ]
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galunisertib [ Time Frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles) ]
- PK: Area Under the Curve (AUC) at Steady State of Galunisertib [ Time Frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles) ]
- PK: Minimum Concentration (Cmin) of Durvalumab [ Time Frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles) ]
- Number of Participants with Anti-Durvalumab Antibodies [ Time Frame: Predose Day 1 Cycle 2 through Predose Day 1 Cycle 4 (28 Day Cycles) ]
- Progression-free Survival (PFS) [ Time Frame: Baseline to Objective Progressive Disease or Death (Estimated up to 18 Months) ]
- Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Objective Progressive Disease (Estimated up to 18 Months) ]
- Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Progressive Disease or Death Due to Any Cause (Estimated up to 18 Months) ]
- Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD) [ Time Frame: Baseline to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Estimated up to 18 Months) ]
- Time to Response [ Time Frame: Baseline to Date of CR or PR (Estimated up to 4 Months) ]
- Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated up to 30 Months) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must have histologic or cytologic confirmation of recurrent metastatic pancreatic adenocarcinoma based on standard diagnostic criteria. Recurrence must be documented by diagnostic biopsy.
- Have measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
- Have had disease progression, been refractory or intolerant to no more than 2 prior systemic regimens for locally advanced or metastatic pancreatic cancer. Participants who have received prior neoadjuvant therapy and who now have metastatic disease must have received 1 of the following for their metastatic disease: FOLFIRINOX, nanoparticle albumin-bound paclitaxel/gemcitabine, TS-1 (tegafur gimeracil oteracil potassium), irinotecan liposome injection/5-fluorouracil (5FU)/Leucovorin or single-agent gemcitabine prior to enrolment in this study.
- Dose Escalation: Able and willing to give valid written consent to undergo a new tumour biopsy (prior to study treatment) or to provide an available archival tumour sample if taken <3 years prior to enrolment if a new tumour biopsy is not feasible with an acceptable clinical risk.
- Cohort Expansion: Able and willing to give valid written consent to undergo a new tumour biopsy (prior to study treatment). Able and willing to undergo a second tumour biopsy on treatment. Where possible, tumour lesions used for new biopsies should not be the same lesions used as RECIST target lesions, unless there are no other lesions suitable for biopsy. Archival samples may be required if there is inadequate tissue in the biopsy specimen.
- Have adequate organ function.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Use approved contraceptive methods.
Exclusion Criteria:
-
Have moderate or severe cardiovascular disease:
- Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension.
- Have documented major electrocardiogram (ECG) abnormalities (not responding to medical treatments; for example, atrial fibrillation, bundle branch blocks, or as approved by the sponsors).
- Have major abnormalities documented by ECHO with Doppler (for example, moderate or severe heart valve function defect including moderate or severe valve stenosis or regurgitation, left ventricular ejection fraction <50%, evaluation based on the institutional lower limit of normal, septal aneurysm or other heart aneurysm, any aneurysm of the major vessels or any condition that results in increased risk of aneurysm (eg, Marfan syndrome, patent foramen ovale [PFO]).
- Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan syndrome, PFO, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computerized tomography [CT] scan with contrast or magnetic resonance imaging [MRI]).
- Have evidence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active, noninfectious pneumonitis.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734160
United States, Arizona | |
Honor Health Research Institute | |
Scottsdale, Arizona, United States, 85258 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Tennessee | |
Sarah Cannon Research Institute SCRI | |
Nashville, Tennessee, United States, 37203 | |
Tennessee Oncology PLLC | |
Nashville, Tennessee, United States, 37203 | |
France | |
Gustave Roussy | |
Villejuif Cedex, France, 94805 | |
Italy | |
Ospedale Policlinico Giambattista Rossi, Borgo Roma | |
Verona, Italy, 37134 | |
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Korea, Republic of, 06351 | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 03080 | |
Spain | |
Hospital Universitari Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Universitario 12 de Octubre | |
Madrid, Spain, 28041 | |
Hospital Madrid Norte Sanchinarro | |
Madrid, Spain, 28050 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT02734160 |
Other Study ID Numbers: |
15784 H9H-MC-JBEG ( Other Identifier: Eli Lilly and Company ) 2015-005295-26 ( EudraCT Number ) |
First Posted: | April 12, 2016 Key Record Dates |
Last Update Posted: | August 5, 2019 |
Last Verified: | August 1, 2019 |
immunotherapy check point inhibitors transforming growth factor (TGF)-beta R1 kinase inhibitor |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases |
Pancreatic Diseases Endocrine System Diseases Durvalumab Antineoplastic Agents, Immunological Antineoplastic Agents |