A Phase 1/2 interventional study of LY2157299 and Radiation in Glioma, sponsored by Eli Lilly and Company. Completed at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-16.
Sponsored by Eli Lilly and Company · Phase 1/2, Interventional, and Treatment
The purpose of this trial is to show proof of concept that by blocking the Transforming Growth Factor-beta signaling pathway in patients with Glioblastoma, there will be clinical benefit.
Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with radiochemotherapy with temozolomide for Phase 2 in patients with glioma eligible to receive radiochemotherapy with temozolomide (e.g. newly diagnosed malignant glioma World Health Organization Grade III and IV).
Phase 2a: To confirm the tolerability and evaluate the pharmacodynamic effect of LY2157299 in combination with standard radiochemotherapy in patients with newly diagnosed glioblastoma.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's enrollment of 75 is above the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 141 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have moderate or severe cardiac disease as defined by any of the following:
During Radiation therapy: * Radiation:Approximate 1.8 - 2.0 Gy x 30 fractions. Approximate total dose = 60.0 Gy taken 5 days per week for 6 weeks. * LY2157299: 80 mg taken twice daily for 14 days on followed 14 days of pause. This on/off schedule constitutes a cycle of 28 days. * Temozolomide: 75 mg/m2 taken daily for 6 weeks. After Radiation Therapy: * LY2157299: 80 mg taken twice daily for 14 days on followed 14 days of pause. This on/off schedule constitutes a cycle of 28 days. Taken for a 6 cycles. * Temozolomide: 150 mg/m2 and then 200 mg/m2 daily during the off time of LY2157299. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles.
Drug: LY2157299 · Drug: Radiation · Drug: Temozolomide
During Radiation therapy: * Radiation:Approximate 1.8 - 2.0 Gy x 30 fractions. Approximate total dose = 60.0 Gy taken 5 days per week for 6 weeks. * LY2157299: 150 mg taken twice daily for 14 days on followed 14 days of pause. This on/off schedule constitutes a cycle of 28 days. * Temozolomide: 75 mg/m2 taken daily for 6 weeks. After Radiation Therapy: * LY2157299: 150 mg taken twice daily for 14 days on followed 14 days of pause. This on/off schedule constitutes a cycle of 28 days. Taken for a 6 cycles. * Temozolomide: 150 mg/m2 and then 200 mg/m2 daily during the off time of LY2157299. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles.
Drug: LY2157299 · Drug: Radiation · Drug: Temozolomide
During Radiation therapy: * Radiation:Approximate 1.8 - 2.0 Gy x 30 fractions. Approximate total dose = 60.0 Gy taken 5 days per week for 6 weeks. * LY2157299: Phase 1 established dose taken twice daily for 14 days on followed 14 days of pause. This on/off schedule constitutes a cycle of 28 days. * Temozolomide: 75 mg/m2 taken daily for 6 weeks. After Radiation Therapy: * LY2157299: Phase 1 established dose taken twice daily for 14 days on followed 14 days of pause. This on/off schedule constitutes a cycle of 28 days. Taken for a 6 cycles. * Temozolomide: 150 mg/m2 and then 200 mg/m2 daily during the off time of LY2157299. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles.
Drug: LY2157299 · Drug: Radiation · Drug: Temozolomide
During Radiation therapy: * Radiation:Approximate 1.8 - 2.0 Gy x 30 fractions. Approximate total dose = 60.0 Gy taken 5 days per week for 6 weeks. * Temozolomide: 75 mg/m2 taken daily for 6 weeks. After Radiation Therapy: Temozolomide: 150 mg/m2 and then 200 mg/m2 daily during the off time of LY2157299. Starting 28 days after the completion of radiation therapy. Taken for 5 days followed by 23 days of rest for 6 cycles.
Drug: Radiation · Drug: Temozolomide
Administered orally
Administered as approved
Administered orally
Phase 1: Recommended dose for Phase 2 portion
Time frame: Baseline to phase 1 completion
Phase 2: Relationship of change in response biomarker to clinical benefit
Time frame: Baseline through discontinuation from any cause
Phase 1: Pharmacokinetics - Concentration Maximum
Time frame: Baseline, prior to first dose of cycle 1 and 2 and on days 1, 3, 8, 14, 15 and 16
Phase 1: Number of patients with a tumor response
Time frame: Baseline to Progressive Disease
Phase 2: Overall Survival at 12 Months
Time frame: Randomization to date of death from any cause at 12 months
Phase 2: Overall Survival
Time frame: Randomization to date of death from any cause
Phase 2: Progression Free Survival
Time frame: Randomization to measured progressive disease or death from any cause
Phase 2: Proportion of patients achieving an objective response (Response Rate)
Time frame: Randomization to measured progressive disease
Phase 2: Duration of tumor Response
Time frame: Time of response to measured progressive disease or death from any cause
Phase 2: Time to Treatment Failure
Time frame: Randomization to the date of discontinuation of study treatment due to adverse event, progression of disease, or death from any cause
Phase 1: Pharmacokinetics - Time to Concentration Maximum
Time frame: Baseline, prior to first dose of cycle 1 and 2 and on days 1, 3, 8, 14, 15 and 16
Phase 1: Pharmacokinetics - Area under the Curve
Time frame: Days 12 to 14 in cycle 1 and in cycle 3
Phase 2: Change from baseline in MD Anderson Symptom Inventory - Brain Tumor
Time frame: Baseline, 30 day post study day follow-up
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company