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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02105350
Other study ID # Biliary GEMOX / MEK
Secondary ID
Status Withdrawn
Phase Phase 1
First received April 2, 2014
Last updated February 14, 2018
Start date June 2015
Est. completion date June 2015

Study information

Verified date February 2018
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- Planning on embarking on a new strenuous exercise regimen after first dose of study treatment.

- Impairment of gastrointestinal function or gastrointestinal disease.

- Any other condition that would contraindicate participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MEK 162

Gemcitabine

Oxaliplatin


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Outcome

Type Measure Description Time frame Safety issue
Primary Total incidence of grade 3 and 4 adverse events 2 years
Primary Total rate of grade 3 and 4 adverse events 2 years
Primary Maximum dose level at which 0/3 patients or 1/6 patients experience dose-limiting toxicity 2 years
Secondary Number of patients with objective response rate 2 years
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT04003636 - Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966) Phase 3
Not yet recruiting NCT05064852 - A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma
Recruiting NCT05668884 - GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma Phase 2
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Active, not recruiting NCT02151084 - A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer Phase 2
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Not yet recruiting NCT06430827 - Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma Phase 2
Recruiting NCT06047990 - Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction N/A
Active, not recruiting NCT04924062 - Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study Phase 3
Not yet recruiting NCT06463548 - Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma N/A
Terminated NCT04178460 - A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment Phase 1
Completed NCT03027284 - A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer Phase 1
Recruiting NCT06199882 - SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma Phase 2
Active, not recruiting NCT05023109 - GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC Phase 2
Not yet recruiting NCT06168292 - Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma N/A
Recruiting NCT04979663 - GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer Phase 1/Phase 2