Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Participants With Metastatic Pancreatic Ductal Adenocarcinoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Cardiff Oncology
Study ID
NCT04752696
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The main objective of this trial is to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).

Key Dates

Start date
May 25, 2021
Status verified
Dec 2025
Primary completion
Dec 24, 2024
Completion
Dec 24, 2024

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-in: Onvansertib + nal-IRI + leucovorin + 5-FU
    The first 3 participants will be administered onvansertib orally once a day at a dosing schedule of 12 mg/m\^2 on Day 1 to Day 10 for two cycles, where each cycle is 2 weeks. Depending on the number of dose limiting toxicities (DLTs) experienced in the first 3 participants, additional participants may receive different dosing schedules, determining the dosing schedule to be used in the treatment period. Onvansertib will be administered in combination with 70 mg/m\^2 nanoliposomal irinotecan (nal-IRI), 400 mg/m\^2 leucovorin and 2400 mg/m\^2 fluorouracil (5-FU).
  • Experimental: Treatment Period: Onvansertib + nal-IRI + leucovorin + 5-FU
    Participants will be administered onvansertib at the dosing schedule selected based on the results of the safety lead-in, in cycles of 2 weeks. Onvansertib will be administered in combination with 70 mg/m\^2 nanoliposomal irinotecan (nal-IRI), 400 mg/m\^2 leucovorin and 2400 mg/m\^2 fluorouracil (5-FU).

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo Clinic PhoenixPhoenixArizona85054-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
University of Kansas Medical CenterWestwoodKansas66205-
Mayo Clinic RochesterRochesterMinnesota55905-
University of Nebraska Medical CenterOmahaNebraska68198-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in Phoenix, AZ

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Mayo Clinic Phoenix· Phoenix, AZMayo Clinic Jacksonville· Jacksonville, FLUniversity of Kansas Medical Center· Westwood, KSMayo Clinic Rochester· Rochester, MNUniversity of Nebraska Medical Center· Omaha, NEInova Schar Cancer Institute· Fairfax, VA

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