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History of Changes for Study: NCT02734160
A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer
Latest version (submitted August 2, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 6, 2016 None (earliest Version on record)
2 May 9, 2016 Study Status and Contacts/Locations
3 June 6, 2016 Study Status
4 June 15, 2016 Contacts/Locations and Study Status
5 July 15, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
6 July 19, 2016 Contacts/Locations and Study Status
7 July 27, 2016 Contacts/Locations and Study Status
8 July 28, 2016 Contacts/Locations and Study Status
9 September 8, 2016 Study Status and Contacts/Locations
10 September 9, 2016 Contacts/Locations and Study Status
11 September 22, 2016 Contacts/Locations and Study Status
12 November 16, 2016 Contacts/Locations, Study Status and References
13 December 6, 2016 Study Status and Contacts/Locations
14 January 11, 2018 Study Status
15 February 1, 2018 Contacts/Locations and Study Status
16 March 28, 2018 Study Status and Contacts/Locations
17 May 11, 2018 Contacts/Locations and Study Status
18 July 5, 2018 Recruitment Status, Study Status and Contacts/Locations
19 July 23, 2018 Study Status
20 October 26, 2018 Study Status, Contacts/Locations and Study Design
21 November 2, 2018 Study Status
22 November 19, 2018 Study Status
23 December 3, 2018 Study Status
24 August 2, 2019 Recruitment Status and Study Status
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Study NCT02734160
Submitted Date:  April 6, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 15784
Brief Title: A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer
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
Secondary IDs: H9H-MC-JBEG [Eli Lilly and Company]
2015-005295-26 [EudraCT Number]
Open or close this module Study Status
Record Verification: April 2016
Overall Status: Not yet recruiting
Study Start: June 2016
Primary Completion: April 2018 [Anticipated]
Study Completion: April 2019 [Anticipated]
First Submitted: April 6, 2016
First Submitted that
Met QC Criteria:
April 6, 2016
First Posted: April 12, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 6, 2016
Last Update Posted: April 12, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Eli Lilly and Company
Responsible Party: Sponsor
Collaborators: AstraZeneca
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Metastatic Pancreatic Cancer
Keywords: immunotherapy
check point inhibitors
transforming growth factor (TGF)-beta R1 kinase inhibitor
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 37 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Galunisertib + Durvalumab
(Dose Escalation and Cohort Expansion) Galunisertib administered orally in combination with durvalumab administered intravenously (IV).
Drug: Galunisertib
Administered orally
Other Names:
  • LY2157299
Drug: Durvalumab
Administered IV
Other Names:
  • MEDI4736
Open or close this module Outcome Measures
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) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Telephone: 1-317-615-4559
Study Officials: 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)
Study Director
Eli Lilly and Company
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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