Evaluation of Safety and Activity of an Anti-PDL1 Antibody (DURVALUMAB) Combined With CSF-1R TKI (PEXIDARTINIB) in Patients With Metastatic/Advanced Pancreatic or Colorectal Cancers

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

November 30, 2019

Study Completion Date

December 31, 2019

Conditions
Colorectal CancerPancreatic CancerMetastatic CancerAdvanced Cancer
Interventions
DRUG

Pexidartinib

Treatment will be administered as long as patient experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. If a DLT or a toxicity meeting the DLT definition but occurring outside of the DLT period, resolves to Grade ≤2 or the patient's baseline level within 14 days after toxicity onset, dosing may be resumed if agreed by the Sponsor at the same DL.

DRUG

Durvalumab

Treatment will be administered as long as patient experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. If a DLT or a toxicity meeting the DLT definition but occurring outside of the DLT period, resolves to Grade ≤2 or the patient's baseline level within 14 days after toxicity onset, dosing may be resumed if agreed by the Sponsor at the same DL.

Trial Locations (2)

31059

IUCT-oncopole, Toulouse

69008

Centre Léon Bérard, Lyon

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Plexxikon

INDUSTRY

lead

Centre Leon Berard

OTHER