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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neoplasms

Secondary outcome measures

Disease

Overall survival in months

Percentage of patients without progressive disease

+3 more

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%

Hypocalcemia

19%

Hyponatremia

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

Hypoglycemia

Acute kidney injury

Anorexia

Death, NOS

Periorbital edema

Skin hypopigmentation

Pain in extremity

Cough

Insomnia

Alkaline phosphatase increased

Dry mouth

Sepsis

Renal and urinary disorders - Other

Dehydration

Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis

Hypernatremia

Blood and lymphatic system disorders - Other

Hypercalcemia

Metabolism and nutrition disorders - Other

Chills

Hypotension

Myalgia

Arthralgia

Upper respiratory infection

Headache

Sinusitis

Generalized muscle weakness

Gastrointestinal disorders - Other

Gastroesophageal reflux disease

Confusion

Vaginal inflammation

Pruritus

Febrile neutropenia

Flu like symptoms

Hepatic failure

Skin infection

Fall

Fracture

Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral

Adult respiratory distress syndrome

Renal and urinary disorders - Other, Acute renal failure

INR increased

100%

80%

60%

40%

20%

Study treatment Arm

AZD6244 (Selumetinib) 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

Gemcitabine

FDA approved

Selumetinib

FDA approved

Cisplatin

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,471 Previous Clinical Trials

484,913 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

Bile Duct Cancer Research Study Groups: Arm B (Sequential Dosing), Arm C (Standard Care), Arm A (Continuous Dosing)

Bile Duct 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the FDA's decision on Selumetinib?

"Selumetinib's safety is based on Phase 2 trial data, which only provides weak evidence for its safeness. There is no data supporting Selumetinib's efficacy."

Answered by AI

How many test subjects are needed for this clinical trial?

"This particular clinical trial is not currently enrolling patients. The original posting date was November 1st, 2014 with the most recent edit on April 14th, 2021. However, there are 2559 other trials actively recruiting participants with biliary tract carcinoma and 1043 studies involving Selumetinib that are still looking for patients."

Answered by AI

Does Selumetinib have a history of being effective in research trials?

"Selumetinib is being researched in a total of 1043 clinical trials, with 352 of those research projects currently in the third phase. Most of these medical studies are taking place Shanghai, but there are 53855 different locations where researchers are looking into Selumetinib's efficacy."

Answered by AI

Are researchers still enrolling new participants for this experiment?

"This study is not presently looking for participants, though it was last updated on April 14th, 2021. If you are searching for other trials, there are 2559 biliary tract carcinoma studies and 1043 Selumetinib studies that are currently enrolling patients."

Answered by AI