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Kinase Inhibitor

Combination Therapy for Sarcoma

Phase 2

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥ 18 years of age

Patients must have histologically confirmed soft tissue or bone sarcoma of specific subtypes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat patients with sarcomas that have not responded to other treatments. The first part of the trial is open to all patients with sarcomas, and the second part is for patients with a specific type of sarcoma.

Who is the study for?

Adults (18+ years) with specific sarcomas, including MPNST and no standard treatment options left. They must have measurable disease, be over 30 kg in weight, recovered from previous treatments' side effects, not used certain inhibitors or immunosuppressants recently, and have proper organ function. Women of childbearing potential must use effective birth control.Check my eligibility

What is being tested?

The trial is testing Selumetinib combined with a Bromodomain Inhibitor and Durvalumab on patients with refractory/unresectable sarcomas. It's an open-label phase 1/2 study where all participants receive the experimental drugs to see how well they work and what the side effects are.See study design

What are the potential side effects?

Potential side effects may include skin rash, eye problems like blurred vision or dry eyes due to Selumetinib; fatigue, nausea from Bromodomain Inhibitors; immune-related reactions such as inflammation of organs or infusion-related symptoms from Durvalumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is a specific type of sarcoma in the soft tissue or bone.

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I am using reliable birth control and my pregnancy tests are negative.

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I am using or willing to use birth control or have stored sperm before starting the treatment.

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My condition hasn't improved with standard treatments or there are no treatments available for it.

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I weigh more than 30 kilograms.

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My kidney function, heart's pumping ability, and heart rhythm are normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determine the Clinical Benefit of Selumetinib, BI and Durvalumab

Safety and Tolerability Selumetinib with BI

Safety and Tolerability of Durvalumab with Selumetinib and BI

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

Acute kidney injury

Hypoglycemia

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

1Treatment groups

Experimental Treatment

Group I: Phase 1 and 2 Study of Selumentinib, BI and DurvalumabExperimental Treatment1 Intervention

Part A will be a phase 1 dose escalation study of the combination with selumetinib and BI, and, Part B will be phase 1 study combining the determined dose of selumetinib and BI from Part A with durvalumab. Part C will be a phase 2 study combining selumetinib, BI with durvalumab in MPNST patients at the recommended doses from part B. A Simon's two-stage design will be used in the phase 2 trial to determine the clinical benefit in patients with unresectable or metastatic NF associated MPNST.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Selumetinib

2010

Completed Phase 2

~2050

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,583 Previous Clinical Trials

2,280,003 Total Patients Enrolled

United States Department of DefenseFED

861 Previous Clinical Trials

227,153 Total Patients Enrolled

3 Trials studying Sarcoma

66 Patients Enrolled for Sarcoma

Media Library

Selumetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05253131 — Phase 2

Sarcoma Research Study Groups: Phase 1 and 2 Study of Selumentinib, BI and Durvalumab

Sarcoma Clinical Trial 2023: Selumetinib Highlights & Side Effects. Trial Name: NCT05253131 — Phase 2

Selumetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05253131 — Phase 2

Frequently Asked Questions

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

Does this study include individuals aged seventy and above?

"The age requirements for this trial are 18 and 99, respectively. Any persons not within those parameters will unfortunately be unable to participate."

Answered by AI

Are there still openings for volunteers to participate in this clinical research?

"Clinicaltrials.gov indicates that this trial, initially posted on December 15th 2022 and last updated October 11th 2022, is not currently recruiting patients. Nevertheless, 449 other studies are actively searching for participants at the time of writing."

Answered by AI

Are there a number of sites in Canada where this research is being conducted?

"14 different clinical trial sites are enrolling patients, including Children's Hospital Los Angeles in LA, California; the Children's National Medical Center in Washington DC; and Indiana University in Indianapolis."

Answered by AI

What criteria must individuals meet in order to take part in this research?

"To qualify for this medical trial, potential participants must have sarcoma and be within the 18-99 age range. The total number of accepted applicants is capped at 41 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas

Bruce Korf, MD 2024. "Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05253131.

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