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WITHDRAWNPHASE1/PHASE2

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

A Phase Ib/II Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of KRAS p. G12C Mutated Advanced Pancreatic Cancer

NCT05251038•Devalingam Mahalingam

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
•Age ≥ 18 years at the time of consent.
•ECOG Performance Status of 0-1 within 14 days prior to registration.
•Histological or cytological confirmation of pancreatic cancer per AJCC, 8th edition.
•Unresectable or metastatic pancreatic cancer.
•Measurable disease according to RECIST 1.1 within 28 days prior to registration.
•KRAS p. G12C mutation by CLIA certified molecular testing of tumor biopsy or blood based circulating tumor DNA. NOTE: patients must have KRAS p.G12C molecularly confirmed previously or have archived tissue sent for testing and/or undergo biopsy confirming KRAS p.G12C mutation prior to enrollment.
•Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 28 days prior to registration:
•* Hematological
•* Absolute Neutrophil Count (ANC): ≥ 1.5 x 109/L
+27 more criteria

Exclusion Criteria

•Subjects meeting any of the criteria below may not participate in the study:
•Receipt of two or more lines of chemotherapy. NOTE: Adjuvant or neoadjuvant therapy would be counted as one line of therapy if recurrence or development of metastatic disease occurred within 6 months of last dose of adjuvant/neoadjuvant therapy.
•Previous treatment with a KRASG12C inhibitor.
•Patient unable to receive nal-IRI/5FU/LV or GEM/nab-paclitaxel as second line chemotherapy for pancreatic cancer.
•Grade 2 or higher neuropathy preventing treatment with abraxane containing regimen.
•History of pneumonitis and/or interstitial lung disease (ILD).
•History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥ 2 years.
•Surgery within 28 days of enrollment.
•Known dihydropyrimidine dehydrogenase deficiency.
•Use of known CYP3A4 and P-gp sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to study Day 1 that was not reviewed and approved by the principal investigator.
+4 more criteria

Locations (1)

Northwestern University

Chicago, Illinois, United States

Key Dates

Start Date

September 13, 2022

Primary Completion Date

January 31, 2023

Completion Date

January 31, 2023

Last Updated

May 11, 2023

Conditions

Pancreatic CancerUnresectable Pancreatic CancerMetastatic Pancreatic CancerKRAS P.G12C

Interventions

Sotorasib

DRUG

Liposomal Irinotecan (nal-IRI)

DRUG

5 Fluorouracil (5FU)

DRUG

Leucovorin (LV)

DRUG

Gemcitabine (GEM)

DRUG

Nab paclitaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 11, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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