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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.

Must not have

Planned major surgery.

Participants who have had any prior cranial radiotherapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I can swallow pills.

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My cancer does not have the IDH1 R132H mutation.

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My tumor's MGMT promoter is not methylated.

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I have a confirmed diagnosis of glioblastoma or gliosarcoma in my brain after surgery.

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I am 18 years old or older.

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My blood tests show normal organ and marrow function.

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I can care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for a major surgery.

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I have had radiation therapy to my brain before.

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My diabetes is not well-managed.

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I do not have any stomach or intestine problems that could affect how a medicine works in my body.

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My original cancer diagnosis was not upgraded to glioblastoma from a lower grade.

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I am currently using herbal medications.

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I have an active Hepatitis B or C infection.

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I have been diagnosed with pancreatitis.

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I have severe diarrhea that doesn't improve with medication.

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I am currently taking warfarin or similar blood thinners.

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I have heart problems that affect my daily activities.

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I am currently taking antibiotics for an infection.

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I am planning to use Optune™ therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314

36%

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

Aspartate aminotransferase increased

Mucositis oral

Anemia

Vomiting

Constipation

Dehydration

Hypophosphatemia

Platelet count decreased

Sepsis

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Catheter related infection

Colitis

Abdominal pain

Hypotension

White blood cell decreased

GGT increased

Hypocalcemia

Urinary retention

Hypoalbuminemia

Fever

Typhlitis

Anxiety

Neutrophil count decreased

Urinary tract infection

Peripheral motor neuropathy

Enterocolitis

Lipase increased

Pleural effusion

Serum amylase increased

Skin infection

Epistaxis

Urinary tract obstruction

Blood bilirubin increased

Lymphocyte count decreased

Syncope

Wound infection

Dermatitis radiation

Hypertension

Sinus tachycardia

Edema limbs

Bone pain

Dyspnea

Hematuria

Hypercalcemia

Vulval infection

Upper gastrointestinal hemorrhage

Depressed level of consciousness

Thromboembolic event

Stridor

Allergic reaction

Back pain

Lung infection

Urticaria

Acute kidney injury

Muscle weakness lower limb

Musculoskeletal and connective tissue disorder - Other, specify

Pain in extremity

Peripheral sensory neuropathy

Proctitis

Skin ulceration

Apnea

Stoma site infection

Tumor pain

Left ventricular systolic dysfunction

Pancreatitis

Portal hypertension

Rectal hemorrhage

Creatinine increased

Enterocolitis infectious

Hyperkalemia

Investigations - Other, specify

Abdominal distension

Ascites

Heart failure

Vascular disorders - Other, specify

Anal hemorrhage

Vasovagal reaction

Penile pain

Bone marrow hypocellular

Gastrointestinal disorders - Other, specify

Soft tissue infection

Delirium

Tracheitis

Seizure

Hepatobiliary disorders - Other, specify

Esophageal pain

Anal mucositis

Menorrhagia

Sore throat

Anaphylaxis

Fracture

Hydrocephalus

Device related infection

Tooth infection

Gastric ulcer

Sinusitis

Skin and subcutaneous tissue disorders - Other, specify

Pharyngitis

Pyramidal tract syndrome

Anal ulcer

Depression

Ejection fraction decreased

Rash maculo-papular

Pruritus

Myositis

Nail infection

Pain of skin

Pleuritic pain

Pneumonitis

Pneumothorax

Postoperative hemorrhage

Renal and urinary disorders - Other, specify

Respiratory, thoracic and mediastinal disorders - Other, specify

Salivary duct inflammation

Small intestine infection

Alkaline phosphatase increased

Appendicitis

Spinal fracture

Disseminated intravascular coagulation

Ear and labyrinth disorders - Other, specify

Endocrine disorders - Other, specify

Esophageal stenosis

Esophagitis

Gastric hemorrhage

Gum infection

Tumor lysis syndrome

Upper respiratory infection

Hypertriglyceridemia

Hypoxia

Ileus

INR increased

Laryngeal edema

Multi-organ failure

Myelodysplastic syndrome

Oral hemorrhage

Oral pain

Pulmonary edema

Rectal fistula

Rectal pain

Respiratory failure

Bladder spasm

Chest wall pain

Confusion

Congenital, familial and genetic disorders - Other, specify

CPK increased

Dizziness

Encephalopathy

Eye disorders - Other, specify

Generalized muscle weakness

Hoarseness

Hypernatremia

Hypoglycemia

Hypomagnesemia

Insomnia

Irregular menstruation

Irritability

Joint range of motion decreased cervical spine

Kyphosis

Lethargy

Headache

Laryngeal mucositis

Pelvic pain

Esophageal infection

Abdominal infection

Acidosis

Anal fistula

Fall

Fatigue

Gait disturbance

100%

80%

60%

40%

20%

Study treatment Arm

Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)

Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1880

Neratinib

2014

Completed Phase 2

~1970