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Multiple Drug Therapy for Glioblastoma
Phase 2
Recruiting
Led By Patrick Y Wen, MD
Research Sponsored by Patrick Y. Wen, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be able to swallow pills.
Immunohistochemically negative for IDH1 R132H mutation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing several drugs to see if they can treat Glioblastoma, a type of brain tumor.
Who is the study for?
Adults (18+) with confirmed glioblastoma or gliosarcoma, who can swallow pills and have not had prior systemic or radiation therapy for it. They must have adequate organ function, no severe heart disease, uncontrolled diabetes, active infections, or other serious health issues that could affect study participation. Women of childbearing potential and men must use effective contraception.Check my eligibility
What is being tested?
The trial is testing several investigational drugs including Abemaciclib, Temozolomide (Temodar), Neratinib, CC115, and QBS10072S as possible treatments for Glioblastoma. Participants will be assigned to different treatment groups based on genetic markers related to their cancer.See study design
What are the potential side effects?
Potential side effects may include fatigue, digestive issues like nausea and diarrhea, blood disorders such as low platelet counts or anemia, liver enzyme changes indicating liver stress or damage; also the risk of infection might increase due to lowered immune defenses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
Select...
My cancer does not have the IDH1 R132H mutation.
Select...
My tumor's MGMT promoter is not methylated.
Select...
I have a confirmed diagnosis of glioblastoma or gliosarcoma in my brain after surgery.
Select...
I am 18 years old or older.
Select...
My blood tests show normal organ and marrow function.
Select...
I can care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival in Experimental Arms Compared with Standard Therapy
Secondary outcome measures
Association Between Progression Free Survival and Overall Survival Effects Of Experimental Agents
Incidence of Treatment-Emergent Adverse Events
Overall Survival Among Experimental Arms And Biomarker Groups
+1 moreSide effects data
From 2016 Phase 2 trial • 175 Patients • NCT0105531436%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Aspartate aminotransferase increased
9%
Anemia
9%
Mucositis oral
9%
Vomiting
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Anxiety
5%
Typhlitis
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Syncope
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Esophageal pain
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Bone marrow hypocellular
1%
Anaphylaxis
1%
Delirium
1%
Sore throat
1%
Vasovagal reaction
1%
Anal hemorrhage
1%
Soft tissue infection
1%
Tracheitis
1%
Anal mucositis
1%
Seizure
1%
Menorrhagia
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: QBS10072SExperimental Treatment1 Intervention
Daily Radiation for a maximum of 49 days.
QBS10072S will be administered on Day 1 of Radiation Treatment
QBS10072S will be administered post- radiation for up to 6 cycles
Group II: Neratinib with TemozolomideExperimental Treatment2 Interventions
Daily Radiation for a maximum of 49 days.
Temozolomide will be administered orally on a daily dosing schedule
Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy
Neratinib will be taken post radiation at a daily oral pre-determine dose
Group III: TemozolomideActive Control1 Intervention
Daily Radiation for a maximum of 49 days.
Temozolomide will be administered orally on a daily dosing schedule
Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy
Temozolomide will also be administered post radiation for up to 6 cycles (5 days/cycle)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Neratinib
2014
Completed Phase 2
~1970
QBS10072S
2020
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Puma Biotechnology, Inc.Industry Sponsor
57 Previous Clinical Trials
9,692 Total Patients Enrolled
Quadriga Biosciences, Inc.Industry Sponsor
2 Previous Clinical Trials
55 Total Patients Enrolled
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,721 Total Patients Enrolled
10 Trials studying Glioblastoma
1,878 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a major surgery.I have had radiation therapy to my brain before.I do not have any stomach or intestine problems that could affect how a medicine works in my body.I can swallow pills.My cancer does not have the IDH1 R132H mutation.My original cancer diagnosis was not upgraded to glioblastoma from a lower grade.I have had another type of cancer but meet the specific criteria.I am currently using herbal medications.My doctor considers my tumor bleeding significant.I have an active Hepatitis B or C infection.My tumor's MGMT promoter is not methylated.I agree to use birth control during the study.I have a confirmed diagnosis of glioblastoma or gliosarcoma in my brain after surgery.I had surgery for brain cancer but no chemo or radiation.I am 18 years old or older.My cancer's genetic information is being studied or is available.I do not have any uncontrolled illnesses.I have been diagnosed with pancreatitis.I have severe diarrhea that doesn't improve with medication.I am currently taking warfarin or similar blood thinners.My blood tests show normal organ and marrow function.My diabetes is not well-managed.I am currently taking prescribed medications.I had an MRI with gadolinium within the last 21 days and can have MRIs.I have heart problems that affect my daily activities.I can care for myself but may not be able to do active work.I am currently taking antibiotics for an infection.I will start radiation therapy between 14 to 42 days after my surgery.I am planning to use Optune™ therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Temozolomide
- Group 2: Neratinib with Temozolomide
- Group 3: QBS10072S
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.
How many participants are engaged in this therapeutic experiment?
"This healthcare trial is no longer recruiting new patients. Initially posted on February 9th 2017, and last edited August 15th 2022, this study has since been closed to further admissions. However, 441 studies involving glioblastoma treatments remain open for patient recruitment as do 226 trials that employ Temozolomide."
Answered by AI
Is this research a pioneering endeavor?
"Temozolomide has been subject to clinical research since the year 2002, when Schering-Plough completed a 60 patient study. This was followed by Phase 2 drug approval and, presently, there are 226 active trials being conducted in 36 countries across 946 cities."
Answered by AI
Are there any vacancies available to participate in this clinical trial?
"Currently, this research is not taking on any new candidates. It was originally advertised in February 2017 and the listing was last modified on August 15th 2022. If you're looking for other trials related to glioblastoma or Temozolomide, there are 441 and 226 respective studies currently accepting participants."
Answered by AI
What risks do individuals face when taking Temozolomide?
"There is some evidence supporting temozolomide's safety, so it was assigned a score of 2. However, there are yet to be studies proving its efficacy in medical contexts."
Answered by AI
Have any other investigations been conducted with Temozolomide?
"First investigated in 2002 at the Memorial Sloan Kettering Cancer Center, temozolomide has since been studied extensively with a total of 328 studies completed. Currently, 226 trials are actively enrolling participants primarily based out of Boston."
Answered by AI
Is the research being conducted in numerous locations across Canada?
"For this medical trial, patients may enroll at Massachusetts General Hospital in Boston ma, UT MD Anderson Cancer Center in Houston tx, and Lifespan/Rhode island Hospital in Providence RI. Additionally, there are a dozen more locations participating."
Answered by AI
What medical conditions commonly call for the use of Temozolomide?
"Temozolomide is primarily employed to treat nitrosourea. It can additionally be prescribed for advanced directives, refractory mycosis fungoides and neuroblastoma that do not respond well to other treatments."
Answered by AI
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