This study will compare two different regimens for patients with BRCA1/2 or PALB2 mutated metastatic pancreatic cancer after progression on first-line FOLFIRINOX.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Paclitaxel Powder For Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel is an albumin-stabilized nanoparticle formulation of the natural taxane paclitaxel with antineoplastic activity.
Gemcitabine is a hydrochloride salt of an analogue of the antimetabolite nucleoside deoxycytidine with antineoplastic activity.
Cisplatin is an alkylating-like inorganic platinum agent (cis-diamminedichloroplatinum) with antineoplastic activity.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGOverall Response Rate (ORR)
The proportion of patients who achieve complete response (CR) or partial response (PR)
Time frame: 12 months
Overall Survival (OS) Time
The time form the date of randomization to the date of death
Time frame: 6 years
Progression-free Survival (PFS)
Time from the date of randomization to the date of first documented disease progression or death
Time frame: 6 years
Duration of Response (DoR)
The time that criteria are met for complete response (CR) or partial response (PR) until the first date that recurrence or disease progression is objectively documented.
Time frame: 6 years
CA19-9 Response
Percentage decrease in CA19-9
Time frame: 6 years
Number of Adverse Events
Time frame: 6 years
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