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Alkylating Agent
Lomustine + LY2157299 for Brain Cancer
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have histological or cytological evidence of relapsed malignant glioma (such as glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma) for which no treatment of higher priority exists
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy or other investigational therapy for at least 30 days prior to study enrollment and recovered from the acute effects of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of first dose to time of last dose (estimated up to 8 years)
Awards & highlights
Study Summary
This trial is testing a new drug for brain cancer, both alone and in combination with another cancer drug.
Who is the study for?
This trial is for adults with recurrent malignant glioma, such as glioblastoma or anaplastic astrocytoma. Participants must have measurable disease, be able to swallow pills, and use contraception if necessary. They should have good liver, kidney, and blood function and not be on other cancer treatments for at least 30 days.Check my eligibility
What is being tested?
The study tests LY2157299 alone and combined with lomustine in pill form for brain tumors that have come back after treatment. It's a dose-escalation study which means they'll increase the drug amount over time to find the right dose.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, liver issues due to Lomustine; LY2157299 might cause headaches or swelling caused by fluid retention. Side effects can vary based on individual reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain tumor has returned and there are no better treatment options for me.
Select...
I stopped all cancer treatments 30 days ago and have recovered from their immediate side effects.
Select...
I can do most of my daily activities by myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of first dose to time of last dose (estimated up to 8 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of first dose to time of last dose (estimated up to 8 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Dose for Phase 2 Studies
Secondary outcome measures
Biologically Effective Dose Range
Number of Participants with Tumor Response
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC)
+1 moreSide effects data
From 2021 Phase 2 trial • 132 Patients • NCT0217835857%
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: LY2157299 + Lomustine (Part B)Experimental Treatment2 Interventions
LY21547299 will be administered orally by tablet twice daily for two weeks followed by two weeks of no treatment for two 28-day cycles. Part B dose expansion will have starting dose of 80 mg twice daily and may increase up to 150 mg twice daily.
Lomustine will be administered orally by capsule once on Day 7 of Cycle 1 after receiving LY2157299, and once after receiving LY2157299 on Day 21 of Cycles 2, 5, 8, 11, and every 4th cycle thereafter.
Group II: LY2157299 (Part A)Experimental Treatment1 Intervention
Administered orally by tablet twice daily for two weeks followed by two weeks of no treatment for two 28-day cycles. Part A dose escalation will have starting dose of 40 mg/day and may increase up to 360 mg/day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lomustine
2008
Completed Phase 3
~1540
LY2157299
2011
Completed Phase 2
~460
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,992 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,186 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently been treated with a drug not yet approved by health authorities.I can do most of my daily activities by myself.My brain tumor has returned and there are no better treatment options for me.I have a serious heart condition.I have been treated with a nitrosourea drug before.I stopped all cancer treatments 30 days ago and have recovered from their immediate side effects.I am using or willing to use approved birth control methods if I can get pregnant.I have heart issues like recent heart attack, severe heart failure, or very high blood pressure.I have conditions or family history that increase my risk of heart vessel aneurysms.I am not pregnant or breastfeeding.I can provide a sample of my tumor tissue for the study.My cancer's progress can be measured with scans.My liver, kidneys, and blood are functioning well.I can swallow pills.I have leukemia.I am willing to use contraception during the study and for 3-6 months after.
Research Study Groups:
This trial has the following groups:- Group 1: LY2157299 + Lomustine (Part B)
- Group 2: LY2157299 (Part A)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted its seal of approval to LY2157299?
"This is a Phase 1 trial, so the safety of LY2157299 has been estimated at a score of 1 due to sparse evidence in support of its efficacy and security."
Answered by AI
How many individuals are taking part in this research project?
"This scientific trial is no longer recruiting participants and was last updated on October 18th 2022. Alternatives can be found by searching for studies related to glioma, of which there are currently 356 actively enrolling patients, or LY2157299 with 24 active trials seeking candidates."
Answered by AI
Are there currently any vacancies for individuals to partake in this research?
"Currently, this trial is not enrolling any further patients. It was initially posted in December of 2005 and revised on October 18th 2022. If you are seeking alternative trials for glioma there are presently 356 clinical studies accepting applicants; additionally, 24 research protocols are open to those interested in LY2157299."
Answered by AI
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