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Hormone Therapy

Galunisertib + Enzalutamide for Prostate Cancer

Phase 2
Recruiting
Led By Channing Paller, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
ECOG performance status 0 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing if adding LY2157299 to enzalutamide helps people with metastatic castration-resistant prostate cancer live longer without their disease getting worse.

Who is the study for?
Men over 18 with metastatic castration-resistant prostate cancer who've had abiraterone treatment and can take pills. They need to be well enough for daily activities, have a life expectancy over 3 months, and agree to birth control use. Excluded are those with recent surgery, certain heart diseases, seizures, brain metastases, prior specific treatments for this cancer stage or autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing if adding Galunisertib (LY2157299) to Enzalutamide improves the time patients live without their prostate cancer getting worse compared to just taking Enzalutamide alone. Patients will be randomly assigned to one of these two treatment arms.See study design
What are the potential side effects?
Possible side effects include fatigue, digestive issues like nausea or diarrhea from Enzalutamide; LY2157299 might cause similar problems plus potential liver changes and skin reactions. Each person's reaction can vary.

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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I can do all my daily activities without help.
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I agree to have a tumor biopsy before and during treatment if it's safe.
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My prostate cancer has spread and is not responding to hormone therapy.
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I have been treated with abiraterone before.
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I can take pills by mouth.
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My organ and bone marrow functions meet the required levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Progression free survival in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2) using RECIST 1.1 criteria.
Secondary outcome measures
Number of patients experiencing treatment-related toxicities
Overall survival (OS) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).
Tumor marker kinetics (PSA) in patients with metastatic castration-resistant prostate cancer treated with enzalutamide and LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).

Side effects data

From 2021 Phase 2 trial • 132 Patients • NCT02178358
57%
Palmar-plantar erythrodysaesthesia syndrome
45%
Hypophosphataemia
39%
Diarrhoea
36%
Decreased appetite
35%
Pyrexia
35%
Aspartate aminotransferase increased
31%
Alanine aminotransferase increased
31%
Fatigue
27%
Rash
26%
Platelet count decreased
23%
Anaemia
22%
Abdominal pain
20%
Hypertension
20%
Vomiting
20%
Alopecia
19%
Nausea
18%
Dermatitis acneiform
18%
Pruritus
15%
Blood bilirubin increased
14%
Constipation
14%
Blood alkaline phosphatase increased
14%
Hypokalaemia
12%
Neutrophil count decreased
12%
Gamma-glutamyltransferase increased
11%
Cough
11%
Abdominal distension
11%
Blood lactate dehydrogenase increased
9%
Hypoalbuminaemia
9%
Rash maculo-papular
9%
Dyspepsia
9%
Influenza like illness
9%
Stomatitis
9%
Proteinuria
9%
Headache
8%
Dyspnoea
8%
Genital disorder female
8%
Ascites
8%
Hypocalcaemia
8%
Insomnia
8%
Dysphonia
7%
Dizziness
7%
Weight decreased
7%
Blood creatine phosphokinase increased
7%
Hyponatraemia
5%
Oedema peripheral
5%
Rash pustular
5%
Malaise
5%
Upper gastrointestinal haemorrhage
5%
Mucosal inflammation
5%
Pain
5%
Lymphocyte count decreased
5%
White blood cell count decreased
5%
Oropharyngeal pain
5%
Erythema
4%
Back pain
4%
Oesophageal varices haemorrhage
4%
Epistaxis
3%
Upper respiratory tract infection
3%
Gastrointestinal haemorrhage
3%
Hyperglycaemia
3%
Arthralgia
3%
Myalgia
3%
Musculoskeletal pain
3%
Dry skin
1%
Cerebral haemorrhage
1%
Hypomagnesaemia
1%
Rectal haemorrhage
1%
Haemoptysis
1%
Haemorrhoids
1%
Endocarditis bacterial
1%
Oesophageal candidiasis
1%
Palpitations
1%
Chills
1%
Non-cardiac chest pain
1%
Leukopenia
1%
Vertigo
1%
Myocardial infarction
1%
Febrile neutropenia
1%
Lymphadenopathy
1%
Hepatic failure
1%
Haematochezia
1%
Duodenal ulcer haemorrhage
1%
Food poisoning
1%
Gastritis
1%
Gastritis haemorrhagic
1%
Hepatic haemorrhage
1%
Chest pain
1%
Cellulitis
1%
Pneumonia
1%
Hepatic rupture
1%
Influenza
1%
Hepatic encephalopathy
1%
Urticaria
1%
Abdominal pain upper
1%
Shock
1%
Toothache
1%
Thrombocytopenia
1%
Asthenia
1%
Lipase increased
1%
Pleural effusion
1%
Productive cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
150 mg Galunisertib + 400 mg Sorafenib Therapy
150 mg Galunisertib Monotherapy
400 mg Sorafenib + Placebo Therapy

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Enzalutamide aloneExperimental Treatment1 Intervention
Group II: Arm 1: Enzalutamide with LY2157299Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
LY2157299
2011
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,820 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,288 Patients Enrolled for Prostate Cancer
Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,199,372 Total Patients Enrolled
14 Trials studying Prostate Cancer
1,956 Patients Enrolled for Prostate Cancer
Channing Paller, MDPrincipal InvestigatorJohns Hopkins University
5 Previous Clinical Trials
614 Total Patients Enrolled
2 Trials studying Prostate Cancer
515 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02452008 — Phase 2
Prostate Cancer Research Study Groups: Arm 1: Enzalutamide with LY2157299, Arm 2: Enzalutamide alone
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02452008 — Phase 2
Enzalutamide (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02452008 — 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 official stance of the FDA on LY2157299?

"LY2157299's score of 2 on a scale from 1 to 3 comes from being in Phase 2 clinical trials. While there is evidence that the medication is safe, its efficacy has not yet been studied."

Answered by AI

Are people with the target condition able to enroll in this research project at this time?

"Yes, an updated check of the clinicaltrials.gov website shows that this study is still seeking participants. This trial was first publicized on May 3rd, 2016 and was most recently updated on June 1st, 2022. The research team hopes to enroll 60 patients total at three different locations."

Answered by AI

Are there any other ongoing studies that include LY2157299?

"There are currently one hundred and nine clinical trials underway for LY2157299 with thirty of them in the third phase. Out of the five thousand seven hundred and eighty-three locations conducting these studies, several are based in Germantown, Tennessee."

Answered by AI

Will this research be extending to patients that are beyond the age of 50?

"The age bracket for this study starts at 18 years old and ends at 100 years old."

Answered by AI

Which patients fit the screening criteria for this experiment?

"The prerequisites for this study are that the patient has prostate cancer and is between 18-100 years old. Currently, the researchers conducting this trial 60 individuals to test their hypothesis."

Answered by AI
~1 spots leftby Jun 2024