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Alkylating agent

Selumetinib + Cisplatin/Gemcitabine for Biliary Cancer

Phase 2
Waitlist Available
Led By Jennifer Knox, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable, recurrent or metastatic, measurable biliary tract cancer or gall bladder cancer
Performance status 0, 1, or 2
Must not have
Prior chemotherapy for non-resectable or metastatic disease or a MEK inhibitor
Progressing within 6 months of adjuvant treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks post initiation of therapy
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial will compare two schedules of selumetinib given with cisplatin and gemcitabine to cisplatin and gemcitabine alone.

Who is the study for?
Adults with advanced biliary or gallbladder cancer who haven't had systemic therapy can join this trial. They should be in a condition to perform daily activities (performance status 0, 1, or 2), have an expected lifespan of over three months, and their blood counts and organ functions must meet certain standards. Pregnant women, those with recent other cancers, severe heart or eye conditions, uncontrolled diseases like hepatitis or HIV are excluded.
What is being tested?
This phase II study is testing the effectiveness of Selumetinib combined with Cisplatin/Gemcitabine versus just Cisplatin/Gemcitabine in patients. Selumetinib is taken orally and targets cell growth regulation while both Cisplatin and Gemcitabine are given intravenously to damage DNA in tumor cells.
What are the potential side effects?
Selumetinib may cause rash, fatigue, nausea, diarrhea; vision changes are also possible due to its effect on cell growth pathways. Cisplatin and Gemcitabine can lead to side effects such as kidney damage, hearing problems for the former; low blood counts causing infection risk for both.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer in the bile duct or gallbladder cannot be removed by surgery and has spread.
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I can take care of myself but might not be able to do heavy physical work.
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I have not had any drug treatments that work throughout my body.
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I do not have any ongoing infections that aren't under control.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had chemotherapy or a MEK inhibitor for cancer that couldn't be surgically removed.
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My condition worsened within 6 months after my last cancer treatment.
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I have never taken MEK, RAS, or RAF inhibitors and am not allergic to study drugs.
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I do not have any ongoing infections, bleeding disorders, or a history of kidney transplant.
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I have been diagnosed with ampullary carcinoma.
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I have had problems with my eyes in the past.
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I am currently receiving treatment aimed at curing my condition.
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I have another cancer that might affect how my treatment response is measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks post initiation of therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks post initiation of therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neoplasms

Side effects data

From 2012 Phase 2 trial • 37 Patients • NCT01085214
75%
Diarrhea
50%
Fatigue
47%
Anemia
47%
Rash acneiform
44%
Hypoalbuminemia
44%
Edema, limbs
39%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
White blood cell decreased
31%
Nausea
31%
Vomiting
28%
Platelet count decreased
25%
CPK increased
25%
Hypomagnesemia
22%
Hypertension
19%
Hypophosphatemia
19%
Hyponatremia
19%
Hypocalcemia
19%
Edema, face
17%
Dry skin
17%
Alanine aminotransferase increased
14%
Skin and subcutaneous tissue disorders - Other
14%
Hypokalemia
14%
Creatinine increased
14%
Back pain
14%
Dyspnea
14%
Lymphocyte count decreased
11%
Pain
11%
Fever
11%
Localized edema
11%
Peripheral sensory neuropathy
11%
Hyperkalemia
11%
Dizziness
11%
Abdominal pain
8%
Anorexia
8%
Hypoglycemia
8%
Acute kidney injury
8%
Death, NOS
8%
Periorbital edema
8%
Skin hypopigmentation
8%
Pain in extremity
8%
Cough
8%
Insomnia
8%
Alkaline phosphatase increased
8%
Dry mouth
8%
Sepsis
6%
Blood and lymphatic system disorders - Other
6%
Hypernatremia
6%
Metabolism and nutrition disorders - Other
6%
Renal and urinary disorders - Other
6%
Hypercalcemia
6%
Dehydration
6%
Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis
6%
Chills
6%
Hypotension
6%
Myalgia
6%
Arthralgia
6%
Upper respiratory infection
6%
Headache
6%
Sinusitis
6%
Generalized muscle weakness
6%
Gastrointestinal disorders - Other
6%
Gastroesophageal reflux disease
3%
Vaginal inflammation
3%
Confusion
3%
Pruritus
3%
Febrile neutropenia
3%
Flu like symptoms
3%
Hepatic failure
3%
Skin infection
3%
Fall
3%
Fracture
3%
Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral
3%
Adult respiratory distress syndrome
3%
Renal and urinary disorders - Other, Acute renal failure
3%
INR increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD6244 (Selumetinib) Treatment

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (Standard Care)Experimental Treatment2 Interventions
Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
Group II: Arm B (Sequential Dosing)Experimental Treatment3 Interventions
Run-In: Selumetinib, orally, BID for 5 days (Day -7 to Day -3) with 2 days washout On treatment: Selumetinib, orally, BID from Day 1-5 and 8-19 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
Group III: Arm A (Continuous Dosing)Experimental Treatment3 Interventions
Run-In: Selumetinib, orally, BID for 7 days (Day -7 to Day -1) On treatment: Selumetinib, orally, BID from Day 1-21 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
FDA approved
Cisplatin
FDA approved
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,187 Total Patients Enrolled
Jennifer Knox, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT02151084 — Phase 2
Gallbladder Cancer Research Study Groups: Arm B (Sequential Dosing), Arm C (Standard Care), Arm A (Continuous Dosing)
Gallbladder Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02151084 — Phase 2
Cisplatin (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02151084 — Phase 2
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