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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
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as galunisertib administered in combination with the anti-programmed cell death-ligand 1 (PD-L1) antibody durvalumab in participants with refractory metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Galunisertib Drug: Durvalumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

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




Primary Outcome Measures :
  1. Number of Participants with Galunisertib in Combination with Durvalumab Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 Days) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galunisertib [ Time Frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles) ]
  2. 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) ]
  3. PK: Minimum Concentration (Cmin) of Durvalumab [ Time Frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles) ]
  4. Number of Participants with Anti-Durvalumab Antibodies [ Time Frame: Predose Day 1 Cycle 2 through Predose Day 1 Cycle 4 (28 Day Cycles) ]
  5. Progression-free Survival (PFS) [ Time Frame: Baseline to Objective Progressive Disease or Death (Estimated up to 18 Months) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. Time to Response [ Time Frame: Baseline to Date of CR or PR (Estimated up to 4 Months) ]
  10. Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated up to 30 Months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Eli Lilly and Company
AstraZeneca
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02734160     History of Changes
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
Keywords provided by Eli Lilly and Company:
immunotherapy
check point inhibitors
transforming growth factor (TGF)-beta R1 kinase inhibitor
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs