Phase 2
Completed N=72
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
Glioblastoma · Glioblastoma multiforme · Gliosarcoma
Source: ClinicalTrials.gov NCT00402116 ↗
Enrolled (actual)
72
Serious AEs
31.9%
Results posted
Aug 2020
Primary outcomePrimary: Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin — 250 milligrams (mg)
Summary
There will be 2 phases in this study. Patients will either be enrolled to the first phase or to the second phase, depending upon when they enroll into the study.
The first phase of this study is done to evaluate the safety of enzastaurin in patients. This is done by gradually increasing the dose of the drug in small groups of patients and watching closely for side effects.
In the second phase of the study, the dose determined to be safe will be used with temozolomide during and following radiation therapy to see if the combination can help patients with brain tumors live longer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1- Determination of the Maximum Tolerated Dose (MTD) of Enzastaurin |
250 | — |
| PRIMARY Phase 1 and Phase 2 - Overall Survival (OS) |
18.3 | — |
| SECONDARY Phase 1 - Number of Participants With Adverse Events (AEs) |
0; 1 | — |
| SECONDARY Phase 1 and 2: Association Between Biomarkers and Clinical Outcome |
1.70; 1.69 | — |
| SECONDARY Phase 1 - Response Rate With Macdonald Criteria |
— | — |
| SECONDARY Phase 2 - Number of Participants With Adverse Events (AEs) |
22 | — |
| SECONDARY Number of Participants Undergoing Magnetic Resonance Imaging/Magnetic Resonance Spectroscopy (MRI/MRS) for Clinical Evaluation at Baseline |
35 | — |
| SECONDARY Phase 1 and 2 - Progression-Free Survival (PFS) |
10.6 | — |
| SECONDARY Functional Assessment of Cancer Therapy - Brain (FACT-Br) |
153.5; 156.1; 151.9; 152.0; 158.9; 158.8 | — |
| SECONDARY M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) |
2.4; 1.8; 0.3; 1.2; 3.3; 2.2 | — |
| SECONDARY Phase 1- Pharmacokinetics (PK): Maximum Observed Drug Concentration During 1 Dosing Interval at Steady State (Cmax,ss) for Enzastaurin, LY326020, and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide |
504; 458; 1350; 719; 370; 392 | — |
| SECONDARY Phase 1 and 2- Pharmacokinetics: Area Under the Concentration-Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Enzastaurin, LY326020 and Total Analyte (Enzastaurin + LY326020) When Enzastaurin Administered With or Without Temozolomide |
5390; 5270; 7720; 16600; 10100; 7260 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have a histologically confirmed diagnosis of intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS).
- Biopsy or resection must have been performed no more than 5 weeks prior to treatment.
- An MRI or CT scan must be obtained within 14 days prior to treatment.
- Patients must not have received prior drug therapy for brain tumors.
- Patients must have adequate organ function demonstrated by lab tests within 14 days prior to treatment.
Exclusion Criteria
- Patients will be excluded if unable to swallow tablets.
- Patients will be excluded if unable to discontinue use of enzyme inducing antiepileptic drugs or have been off of these agents less than 2 weeks prior to treatment (i.e. phenytoin (Dilantin®), carbamazepine, etc.).
- Patients will be excluded if have active infection.
- Patients will be excluded if have a significant medical illness that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
- Patients will be excluded if they have concurrent therapy with an anticoagulant. If the patient requires anticoagulant therapy after starting treatment, the patient may remain on study but should be monitored carefully.
Data sourced from ClinicalTrials.gov (NCT00402116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.