A Study of MEK162 With Gemcitabine and Oxaliplatin in Biliary Cancer

NCT02105350 | Withdrawn Phase 1 DMC

• 1 other identifier: Biliary GEMOX / MEK
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I study (an early study to check the safety of a new drug or drug combination) to find the safest and most tolerated dose of the combination of oxaliplatin with gemcitabine and MEK 162 in patients with biliary cancer (including gallbladder cancers and cancers associated with the bile ducts leading from the gallbladder and to and from the liver) that is not curable by surgery and/or has spread beyond the biliary tree (place where cancer started). Everyone will receive the same standard doses of oxaliplatin and gemcitabine but may receive different doses of MEK 162. MEK 162 is a new drug which plays an important role in the regulation of cell growth and has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. This type of drug has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary cancer.

Conditions

Biliary Tract Carcinoma; Gallbladder Carcinoma

Keywords

MEK162; Gemcitabine; Oxaliplatin; Non-resectable; Recurrent or metastatic

Outcome Measures

Primary Outcomes (3)

• Total incidence of grade 3 and 4 adverse events

  2 years

• Total rate of grade 3 and 4 adverse events

  2 years

• Maximum dose level at which 0/3 patients or 1/6 patients experience dose-limiting toxicity

  2 years

Secondary Outcomes (1)

• Number of patients with objective response rate

  2 years

Study Arms (1)

MEK 162, gemcitabine, and oxaliplatin

EXPERIMENTAL

MEK 162 (30 mg or 45 mg by mouth), twice a day, every day. Gemcitabine (1000 mg/m2 by vein), followed by oxaliplatin (85 mg/m2 by vein) every 2 weeks.

Drug: MEK 162; Drug: Gemcitabine; Drug: Oxaliplatin

Interventions

MEK 162 DRUG

MEK 162, gemcitabine, and oxaliplatin

Gemcitabine DRUG

Also known as: Gemzar

MEK 162, gemcitabine, and oxaliplatin

Oxaliplatin DRUG

Also known as: Eloxatin

MEK 162, gemcitabine, and oxaliplatin

Eligibility Criteria

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

You may qualify if:

• Histopathological or cytological diagnosis of non-resectable, recurrent or metastatic biliary tract (intra- or extra-hepatic) or gallbladder carcinoma.
• Have measurable disease.
• Not received prior systemic therapy for advanced biliary cancer.
• Age 18 years of age or older.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
• Estimated life expectancy is greater than 3 months.
• Have adequate hematological function.
• Have adequate cardiac function.
• All radiology studies performed within 4 weeks prior to the start of therapy.
• No evidence of active uncontrolled infection.
• Ability to understand and willing to sign a written informed consent document.
• Ongoing prior toxicities related to previous treatments received to grade 1 or less at time of registration.
• Able to take oral medications.

You may not qualify if:

• Progressing within 6 months of receiving adjuvant treatment for biliary tract cancer.
• Not have received prior chemotherapy for non-resectable or metastatic disease or MEK inhibitor.
• Histopathological or cytological diagnosis of ampullary carcinoma.
• Incomplete recovery from previous surgery.
• Undergoing current treatment with curative intent.
• History of prior malignancy that could interfere with the response evaluation.
• Any evidence of severe or uncontrolled systemic diseases or laboratory findings that may affect participation in the trial.
• Any psychiatric or other disorder likely to impact on informed consent.
• Pregnant or nursing (lactating) women.
• Agree to use highly effective methods of contraception throughout the study and for 6 months after study drug discontinuation.
• Significant cardiac disease.
• History of retinal degenerative disease.
• History of Gilbert's syndrome.
• Known positive serology for HIV, active hepatitis B, and/or active hepatitis C infection.
• Neuromuscular disorders that are associated with elevated creatine kinase.

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Gallbladder Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Jennifer Knox, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 19, 2018

Record last verified: 2018-02