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A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma


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

Thank you

Trial Information

A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma


Inclusion Criteria:



- Histological confirmed diagnosis of relapsed intracranial GB

- Progressive Disease (PD) following standard chemoradiation

- Prior surgical resection allowed

- Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1

- Adequate hematologic, hepatic and renal function

- Discontinued all prior cancer treatments for cancer & recovered from the acute
effects of therapy

- Tumor specimen must be available for a central pathology review and prognostic and
predictive biomarker evaluation

Exclusion Criteria:

- Moderate or severe heart disease based on New York Heart Association (NYHA) criteria

- Prior nitrosurea therapy (including lomustine or Gliadel)

- Prior bevacizumab as 1st line treatment for GB (if treatment was concluded 12 months
prior to enrollment, the patient may be eligible to participate in the trial)

- Current acute or chronic myelogenous leukemia

- Second primary malignancy that may affect the interpretation of results

- Serious concomitant systemic disorder

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Date of randomization to date of death from any cause estimated up to 2 years

Safety Issue:

No

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:

13849

NCT ID:

NCT01582269

Start Date:

April 2012

Completion Date:

August 2014

Related Keywords:

  • Glioblastoma
  • Glioblastoma

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.Birmingham, Alabama  35294
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.Cincinnati, Ohio  45267
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.Bedford, Texas  76022