Clinical trialPhase 2Completed

Selumetinib Sulfate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12R Mutations

A Phase II Study of Selumetinib (AZD6244) for the Treatment of Advanced Pancreas Cancer Harboring KRAS G12R Mutations

NCT03040986 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Outcome unknown
Phase: Phase 2
Status: Completed
Study type: Interventional
Start: 21 July 2017
Expected end: 15 October 2020
Enrollment: 8 participants
Sites: 9
Primary outcomes: Proportion of Participants With an Objective Response (Partial Response + Complete Response)
Sponsor: Nih
Results posted: 2021-01-11
Last update: 9 February 2021

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Brief summary public domain (ClinicalTrials.gov)

This phase II trial studies how well selumetinib sulfate works in treating patients with pancreatic cancer with Kirsten rat sarcoma (KRAS) G12R mutations that has spread from where it started to nearby tissue or lymph nodes or other places in the body. Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. Determine the objective response rate to selumetinib sulfate (selumetinib) administered as 75 mg orally twice daily on a continuous schedule in patients with advanced pancreas cancer harboring Kirsten rat sarcoma (KRAS) G12R mutations. SECONDARY OBJECTIVES: I. To determine the progression free survival of patients with locally advanced, unresectable and stage IV pancreas cancer treated with selumetinib monotherapy. II. To evaluate the safety of selumetinib in patients with advanced pancreas cancer. III. To determine the impact of additional genetic alterations on the response to selumetinib in pancreas cancer harboring KRAS G12R mutations. IV. To develop a clinically applicable biomarker predicting response to selumetinib in pancreas cancer harboring KRAS G12R mutations. OUTLINE: Patients receive selumetinib sulfate orally (PO) twice daily (BID). Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 52 weeks.

Intervention public domain (ClinicalTrials.gov)

Other: Laboratory Biomarker Analysis. Correlative studies

Intervention public domain (ClinicalTrials.gov)

Drug: Selumetinib Sulfate. Given by mouth (PO)

Arm public domain (ClinicalTrials.gov)

Treatment (selumetinib sulfate) (experimental): Patients receive selumetinib sulfate by mouth (PO) twice daily (BID). Treatment repeats every 28 days for up to 27 courses in the absence of disease progression or unacceptable toxicity

Primary outcome public domain (ClinicalTrials.gov)

Proportion of Participants With an Objective Response (Partial Response + Complete Response). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm (\<1 cm). Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Time frame: Approximately 1-8.2 months.

Secondary outcome public domain (ClinicalTrials.gov)

Median Progression-free Survival (PFS). Time frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 52 weeks.

Secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).. Time frame: Date treatment consent signed to date off study, approximately 25 months and 6 days..

Secondary outcome public domain (ClinicalTrials.gov)

Semi-quantitative Measurements of Connector Enhancer of the Kinase Suppressor of Ras-1 (CNKSR1). Time frame: Up to 52 weeks.

Secondary outcome public domain (ClinicalTrials.gov)

Predictive Biomarkers for Response to Selumetinib. Time frame: Up to 52 weeks.

Secondary outcome public domain (ClinicalTrials.gov)

Longitudinal Biomarker Measuring Response to Treatment. Time frame: start of treatment every (q)2 weeks, up to 52 weeks.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * Patients must have histologically confirmed locally advanced or metastatic pancreas cancer * Patients must have received at least 6 months fluorouracil (5-FU)- or gemcitabine-based treatments for pancreas cancer (fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin \[FOLFIRINOX\], fluorouracil, leucovorin calcium and oxaliplatin \[FOLFOX\], 5-FU+ nal-IRI \[MM-398; nanoliposomal irinotecan\], or 5-FU \[including capecitabine\], gemcitabine-based gemcitabine plus abraxane, gemcitabine monotherapy among others) * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) with conventional techniques or as \>= 10 mm (\>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam * Patients must have Clinical Laboratory Improvement Act (CLIA) confirmed somatic Kirsten rat sarcoma (KRAS) G12R mutation as determined by sequence analysis of matched normal deoxyribonucleic acid (DNA) from any specimen obtained from the individual; patients must provide tumor sample for KRAS analysis or be willing to undergo mandatory screening biopsy * Patients must not have had chemotherapy, molecular therapy with erlotinib, radiation therapy, or experimental biological or molecular therapy for at least 4 weeks prior to starting study medication; patients who received FOLFIRINOX must be 6 weeks from the last administration of therapy; patients must have recovered from any acute toxicity related to prior therapy or surgery, to a grade 1 or less unless specified * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 or Karnofsky \>= 70% * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 75,000/mcL * Hemoglobin (Hgb) \>= 9.0 g/dL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) \< 3 x institutional upper limit of normal * Creatinine =\< institutional upper limit of normal OR * Creatinine clearance \> 60 mL/min/1.73 m\^2 by either Cockcroft-Gault formula or 24-hour urine collection analysis * Patients must be willing to return to the clinic for follow-up visits * Women of child-bearing potential …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 8 participants (actual).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Proportion of Participants With an Objective Response (Partial Response + Complete Response) [Approximately 1-8.2 months]. Number, Proportion of participants. Partial Response: Dose Level 0: 75mg Selumetinib Sulfate Twice Daily (n=6): 0; 75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily (n=2): 0. Complete Response: Dose Level 0: 75mg Selumetinib Sulfate Twice Daily (n=6): 0; 75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily (n=2): 0.