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

NCT05251038 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sotorasib

Intervention instruction outlined in protocol

DRUG

Liposomal Irinotecan (nal-IRI)

Intervention instruction outlined in protocol

DRUG

5 Fluorouracil (5FU)

Per standard of care

DRUG

Leucovorin (LV)

Per standard of care

DRUG

Gemcitabine (GEM)

Per standard of care

DRUG

Nab paclitaxel

Per standard of care

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Devalingam Mahalingam

    lead OTHER

Principal Investigators

  • Devalingam Mahalingam, MD · Northwestern University Feinberg School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05251038 on ClinicalTrials.gov