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Phase 1b/2a Study Combining LY2157299 With Standard Temozolomide-based Radiochemotherapy in Patients With Newly Diagnosed Malignant Glioma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioma

Thank you

Trial Information

Phase 1b/2a Study Combining LY2157299 With Standard Temozolomide-based Radiochemotherapy in Patients With Newly Diagnosed Malignant Glioma


Inclusion Criteria:



- Patients with histologically proven, newly diagnosed and untreated intracranial
glioblastoma including lower grade glioma which evolved into glioblastoma and who
have not received any radiochemotherapy or who have World Health Organization Grade
III malignant glioma (e.g., Anaplastic Astrocytomas, Anaplastic Oligoastrocytomas,
Anaplastic Oligodendroglioma) (Phase 1b only) will be eligible for this protocol

- Biopsy or resection must have been performed no more than 6 weeks prior to treatment

- An Magnetic Resonance Imaging must be obtained within 72 hours after surgery,
preferably within 48 hours

- Patient must not have had prior cranial radiation therapy

- Patients must not have received prior cytotoxic drug therapy, non-cytotoxic drug
therapy, or experimental drug therapy for brain tumors Patients who received Gliadel
wafers at the time of original resection will be excluded

- Patients must plan to begin partial brain radiotherapy within 2-6 weeks after
surgery. Regular fractionated radiotherapy with photons (in any planning mode and
possibly image-guided or stereotactic if deemed necessary) is performed according to
the discretion of the investigator

- Patients must be willing to forego other cytotoxic and noncytotoxic drug therapy
against the tumor while being treated with LY2157299 and temozolomide

- All patients must sign an informed consent indicating that they are aware of the
investigational nature of this study

- Patients must have performance status of 0 or 1 on the Eastern Cooperative Oncology
Group (ECOG) scale

- Patients must have adequate hematologic, hepatic and renal function

- Male and female patients with reproductive potential must use an approved
contraceptive method,during and for 6 months after discontinuation of study treatment
Women of childbearing potential must have a negative human chorionic gonadotropin
pregnancy test documented within 14 days prior to treatment

Exclusion Criteria:

- Are currently enrolled in, or discontinued within the last 30 days from, a clinical
trial involving an investigational drug or device or not approved use of a drug or
device (other than the study drug/device used in this study), or concurrently
enrolled in any other type of medical research judged not to be scientifically or
medically compatible with this study

- Have moderate or severe cardiac disease as defined by any of the following:

- Have the presence of cardiac disease, including a myocardial infarction within 6
months prior to study entry, unstable angina pectoris, New York Heart
Association (NYHA) Class III/IV congestive heart failure, or uncontrolled
hypertension

- Have documented major electrocardiogram (ECG) abnormalities that are symptomatic
and are not medically controlled

- Have major abnormalities documented by echocardiography with Doppler

- Have predisposing conditions that are consistent with development of aneurysms
of the ascending aorta or aortic stress

- Are unable to swallow tablets or capsules

- Are pregnant or breastfeeding

- Have any significant medical illnesses that in the investigator's opinion cannot be
adequately controlled with appropriate therapy or would compromise the patient's
ability to tolerate this therapy

- Have a history of any other cancer (except non-melanoma skin cancer or carcinoma
in-situ of the cervix), unless in complete remission and stopped all therapy for that
disease for a minimum of 3 years are ineligible

- Have active infection that would interfere with the study objectives or influence the
study compliance

- Stereotactic radiosurgery, such as Gamma-Knife treatment, and brachytherapy are not
allowed in this study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1: Recommended dose for Phase 2 portion

Outcome Time Frame:

Baseline to phase 1 completion

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

11585

NCT ID:

NCT01220271

Start Date:

April 2011

Completion Date:

February 2014

Related Keywords:

  • Glioma
  • Glioma
  • Glioblastoma
  • Glioma

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Durham, North Carolina  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenbrae, California  94904
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Jacksonville, Florida  32256
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Chicago, Illinois  60674
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Indianapolis, Indiana  46227