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Metastatic Pancreatic CancerPhase 1NCT02734160

A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer

A Phase 1 study testing Galunisertib and Durvalumab in people with Metastatic Pancreatic Cancer, run by Eli Lilly and Company at 11 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Galunisertib and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
11 sitesin 5 countries
Study dates
15 Jun 2016to 17 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 5 countries.

11 sites in 5 countries

United States4 sites

  • Sarah Cannon Research Institute SCRI

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050

Other trials in Spain

South Korea2 sites

  • Samsung Medical Center

    Seoul, Korea, 06351

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

France1 site

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy1 site

  • Ospedale Policlinico Giambattista Rossi, Borgo Roma

    Verona, 37134

Other trials in Italy

About this study

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

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.

Being tested
Galunisertib, Durvalumab
Keywords
immunotherapy, check point inhibitors, transforming growth factor (TGF)-beta R1 kinase inhibitor
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalunisertibDrug

    Also called LY2157299

    Administered orally

  • DurvalumabDrug

    Also called MEDI4736

    Administered IV

Study groups in NCT02734160
Study groupRoleWhat they receive
Galunisertib + DurvalumabExperimental(Dose Escalation and Cohort Expansion) Galunisertib administered orally in combination with durvalumab administered intravenously (IV).
Receives: Drug: Galunisertib; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Galunisertib in Combination with Durvalumab Dose-Limiting Toxicities (DLTs)

    Measured: Cycle 1 (28 Days)

Secondary outcomes (10)

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galunisertib

    Measured: 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

    Measured: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles)

  3. PK: Minimum Concentration (Cmin) of Durvalumab

    Measured: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles)

  4. Number of Participants with Anti-Durvalumab Antibodies

    Measured: Predose Day 1 Cycle 2 through Predose Day 1 Cycle 4 (28 Day Cycles)

  5. Progression-free Survival (PFS)

    Measured: 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)

    Measured: Baseline to Objective Progressive Disease (Estimated up to 18 Months)

  7. Duration of Response (DoR)

    Measured: 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)

    Measured: Baseline to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Estimated up to 18 Months)

  9. Time to Response

    Measured: Baseline to Date of CR or PR (Estimated up to 4 Months)

  10. Overall Survival (OS)

    Measured: Baseline to Date of Death from Any Cause (Estimated up to 30 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2016 (estimated)
  2. Study start15 Jun 2016
  3. Primary completion2 Aug 2018
  4. Study completion17 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02734160
Sponsor's protocol ID
15784
Other IDs
H9H-MC-JBEG, 2015-005295-26, 2015
Status last verified
1 Aug 2019
First submitted
6 Apr 2016
Last updated
5 Aug 2019
Results posted
No
Data monitoring committee
No

Publications

  • Melisi D, Oh DY, Hollebecque A, Calvo E, Varghese A, Borazanci E, Macarulla T, Merz V, Zecchetto C, Zhao Y, Gueorguieva I, Man M, Gandhi L, Estrem ST, Benhadji KA, Lanasa MC, Avsar E, Guba SC, Garcia-Carbonero R. Safety and activity of the TGFbeta receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer. J Immunother Cancer. 2021 Mar;9(3):e002068. doi: 10.1136/jitc-2020-002068.

    PubMed 33688022

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Galunisertib and Durvalumab in people with Metastatic Pancreatic Cancer, run by Eli Lilly and Company at 11 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Spain, South Korea, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Galunisertib in Combination with Durvalumab Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (28 Days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02734160, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.

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