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



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:June 15, 2016
End Date:June 17, 2019

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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.


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.
We found this trial at
5
sites
Nashville, Tennessee 37203
Principal Investigator: SMO Sarah Cannon Research Inst.
Phone: 615-329-7615
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Johanna Bendell
Phone: 615-329-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Anna Varghese
Phone: 646-888-4545
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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10510 North 92nd Street
Scottsdale, Arizona 85251
Principal Investigator: Erkut Borazanci
Phone: 480-323-1339
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Villejuif Cedex, 94805
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