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Selumetinib for Myelofibrosis

The University of Chicago, Chicago, IL
Myelofibrosis+1 More ConditionsSelumetinib - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new cancer drug (selumetinib) to see if it is safe when combined with the standard dose of another cancer drug (azacitidine). The study will last about 24 months, and patients will be taken off the study if they experience disease progression, unacceptable toxicity, or other illnesses.

Eligible Conditions
  • Myelofibrosis
  • Leukemia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

1 Primary · 5 Secondary · Reporting Duration: From the start of treatment to the date of death, not to exceed 100 months, whichever comes first.

Month 100
Rate of overall survival.
Month 100
Rate of progression free survival.
Month 100
Rate of overall response.
Month 100
Rate of symptom response.
Month 100
Time to completion of next generation sequencing panel.
Up to 24 months.
Number of patients with adverse events

Trial Safety

Phase-Based Safety

1 of 3

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Side Effects for

AZD6244 (Selumetinib) Treatment
75%Diarrhea
50%Fatigue
47%Anemia
47%Rash acneiform
44%Edema, limbs
44%Hypoalbuminemia
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%Edema, face
19%Hypocalcemia
19%Hyponatremia
17%Alanine aminotransferase increased
17%Dry skin
14%Skin and subcutaneous tissue disorders - Other
14%Hypokalemia
14%Dyspnea
14%Back pain
14%Creatinine increased
14%Lymphocyte count decreased
11%Fever
11%Pain
11%Localized edema
11%Peripheral sensory neuropathy
11%Hyperkalemia
11%Dizziness
11%Abdominal pain
8%Acute kidney injury
8%Skin hypopigmentation
8%Cough
8%Death, NOS
8%Periorbital edema
8%Insomnia
8%Anorexia
8%Hypoglycemia
8%Pain in extremity
8%Alkaline phosphatase increased
8%Dry mouth
8%Sepsis
6%Metabolism and nutrition disorders - Other
6%Renal and urinary disorders - Other
6%Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis
6%Hypotension
6%Chills
6%Hypernatremia
6%Headache
6%Myalgia
6%Dehydration
6%Hypercalcemia
6%Blood and lymphatic system disorders - Other
6%Arthralgia
6%Sinusitis
6%Generalized muscle weakness
6%Upper respiratory infection
6%Gastrointestinal disorders - Other
6%Gastroesophageal reflux disease
3%Skin infection
3%Febrile neutropenia
3%Flu like symptoms
3%Fall
3%Vaginal inflammation
3%Pruritus
3%Fracture
3%Hepatic failure
3%Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral
3%Confusion
3%Adult respiratory distress syndrome
3%Renal and urinary disorders - Other, Acute renal failure
3%INR increased
This histogram enumerates side effects from a completed 2012 Phase 2 trial (NCT01085214) in the AZD6244 (Selumetinib) Treatment ARM group. Side effects include: Diarrhea with 75%, Fatigue with 50%, Anemia with 47%, Rash acneiform with 47%, Edema, limbs with 44%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1 Treatment Group

Azacitidine and selumetinib
1 of 1

Experimental Treatment

18 Total Participants · 1 Treatment Group

Primary Treatment: Selumetinib · No Placebo Group · Phase 1

Azacitidine and selumetinibExperimental Group · 2 Interventions: Azacitidine, Selumetinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Selumetinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the start of treatment to the date of death, not to exceed 100 months, whichever comes first.

Who is running the clinical trial?

University of ChicagoLead Sponsor
950 Previous Clinical Trials
759,532 Total Patients Enrolled
Olatoyosi Odenike, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
76 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

What indications are Selumetinib normally prescribed to treat?

"Selumetinib is commonly prescribed as an induction chemotherapy and also to address cases of refractory anemias, leukemia, myelocytic, acute, multilineage dysplasia." - Anonymous Online Contributor

Unverified Answer

Are there currently enrollees to this research experiment?

"Affirmative. The data hosted on clinicaltrials.gov affirms that this research endeavour is actively looking for participants, with the original posting having been made on September 4th 2018 and a recent update occurring on May 16th 2022. 18 individuals are desired from one medical centre." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment size for this trial?

"Affirmative. The information hosted on clinicaltrials.gov demonstrates that this research project, which was first announced on September 4th 2018, is currently accepting participants. 18 individuals need to be sourced from a single medical site in total." - Anonymous Online Contributor

Unverified Answer

Is there a corpus of literature analyzing the effects of Selumetinib?

"At present, 207 clinical studies are examining Selumetinib. Of these investigations, 37 have progressed to Phase 3. The majority of research is conducted in Saint Louis, Missouri; however other trial sites can be found across the country with a total of 6675 locations offering this treatment." - Anonymous Online Contributor

Unverified Answer

Has Selumetinib received clearance from the Food and Drug Administration?

"As this is a Phase 1 trial, the safety of Selumetinib has been preliminarily assessed and assigned a score of 1. This rating reflects the limited data available concerning efficacy and safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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