A Study of GSK2256098 and Trametinib in Advanced Pancreatic Cancer

NCT02428270 | Completed Phase 2 DMC

• 1 other identifier: MOBILITY-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief Summary

This is a phase 2 study (the second phase in testing a new drug or combination to see how effect the drug or combination is) of investigational drugs GSK2256098 and Trametinib. The purpose of the study is to evaluate the antitumor activity of GSK2256098 and Trametinib in patients with advanced pancreatic cancer.

Conditions

Pancreatic Cancer; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who experience complete response, partial response, or stable disease

  24 weeks

Secondary Outcomes (4)

• Adverse events based on frequency and proportion of total patients, by system organ class and preferred term.

  2 years

• Percentage of patients achieving either a complete or partial tumor response.

  2 years

• Interval between the date of randomization and the earliest date of disease progression or death due to any cause

  2 years

• Interval between the first date of CR or PR and the earliest date of disease progression or death due to any cause.

  2 years

Study Arms (1)

GSK2256098 and Trametinib

EXPERIMENTAL

GSK2256098, orally, at 0.375 or 0.5 mg, once daily, continuously every 28 day cycles. Trametinib, orally at 250 mg or 500 mg, twice daily, continuously every 28 day cycles.

Drug: GSK2256098; Drug: Trametinib

Interventions

GSK2256098 DRUG

Small molecule inhibitor of focal adhesion kinase (FAK)

GSK2256098 and Trametinib

Trametinib DRUG

Allosteric inhibitor of mitogen-activated extracellular signal-regulated kinase (MEK)1 and MEK2 activation and kinase activity.

Also known as: Mekinist

GSK2256098 and Trametinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years or older, able to give written consent
• Pancreatic adenocarcinoma that is not responsive to standard therapies or for which there is no approved or curative therapy or for patients who refuse standard therapy
• Have clinical, radiographic, or serologic progression after one prior line of chemotherapy for advanced disease. Patients who have received two or more prior lines of chemotherapy for advanced disease are not eligible.
• Performance Status score of 0 or 1
• Measureable disease by RECIST version 1.1
• Able to swallow and retain oral medication
• Have malignant disease that is amenable to biopsy and agree to collection of mandatory tumor biopsy samples.
• Agrees to use contraception
• Not pregnant
• Adequate organ system function

You may not qualify if:

• Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapy including investigational drugs within 28 days or 5 half lives. No prior MEK inhibitor, RAF inhibitors or a FAK inhibitors
• Current use of a prohibited medication
• Unresolved toxicity greater than Grade 1 from previous anticancer therapy unless the ongoing toxicity will not introduce additional risk factors and will not interfere with the study procedures.
• Presence of active GI disease or other condition that could affect gastrointestinal absorption or predisposed to GI ulceration
• Evidence of mucosal or internal bleeding
• Anticoagulation with warfarin
• Major surgery within the last four weeks
• Malignancies related to HIV or HBV/HCV
• Known active infection requiring parenteral or oral anti-infective treatment
• Leptomeningeal disease.
• Brain metastases
• QTcF interval ≥ 480 msecs
• History or evidence of current clinically significant uncontrolled arrhythmias
• History of acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting within six months of screening.
• Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• GlaxoSmithKline: collaborator

Study Sites (4)

Juravinski Cancer Center

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Centre

London, Ontario, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

GSK2256098; trametinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Philippe Bedard, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: April 28, 2015
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: October 27, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

CA (4)