Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Devalingam Mahalingam
Study ID
NCT05251038
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • KRAS P.G12C
  • Metastatic Pancreatic Cancer
  • Pancreatic Cancer
  • Unresectable Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • Sotorasib — DRUG
    Intervention instruction outlined in protocol
  • Liposomal Irinotecan (nal-IRI) — DRUG
    Intervention instruction outlined in protocol
  • 5 Fluorouracil (5FU) — DRUG
    Per standard of care
  • Leucovorin (LV) — DRUG
    Per standard of care
  • Gemcitabine (GEM) — DRUG
    Per standard of care
  • Nab paclitaxel — DRUG
    Per standard of care

Study Details

This is a multicenter, non-randomized, open-label, phase Ib/II study to evaluate the safety, tolerability and efficacy of sotorasib in combination with chemotherapy for patients with advanced KRAS p.G12C mutant pancreatic cancer with progression of disease after first line treatment. There will be a safety lead in to determine the safety and tolerability of the sotorasib in combination with standard chemotherapy. A Simon two-stage design will be employed to evaluate the efficacy of sotorasib in combination with standard of care second line chemotherapy.

Key Dates

Start date
Sep 13, 2022
Status verified
Feb 2023
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    Patients will either receive a combination of: Sotorasib + Liposomal Irinotecan (nal-IRI) + 5 Fluorouracil (5FU) + Leucovorin (LV) OR Sotorasib + Gemcitabine (GEM) + Nab-paclitaxel \*The combination of therapy received is based on the participants prior therapy and of the discretion of their treating physician

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-

Find similar trials in Chicago, IL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Northwestern University· Chicago, IL

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