Phase 2
Completed N=109
Study of Enzastaurin Versus Placebo in the Treatment of Patients With Brain Metastases of Lung Cancer, After Whole Brain Radiation Therapy
Source: ClinicalTrials.gov NCT00415363 ↗Enrolled (actual)
109
Serious AEs
63.6%
Results posted
Nov 2020
Primary outcomePrimary: Time to Progression of Brain Metastases — 6.9; 4.9 months
Summary
This study is a multinational study to compare enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer. Approximately 108 patients will be randomly assigned to receive either enzastaurin or placebo after having completed whole brain radiotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression of Brain Metastases |
6.9; 4.9 | — |
| SECONDARY Time to Objective Progression of Brain Metastases |
5.0; 3.7 | — |
| SECONDARY Overall Progression-free Survival (Including Both Progression of Brain and Extracranial Tumor Lesion) |
2.2; 2.0 | — |
| SECONDARY Overall Survival |
3.8; 5.1 | — |
| SECONDARY Overall Response (OR) to Treatment of Extra-cranial Tumor Lesions by Percentage of Participants |
0; 0; 0; 4.5; 12.2; 25.0 | — |
| SECONDARY Best Overall Tumor Response on Brain Metastases by Percentage of Participants |
0; 2.3; 9.3; 4.5; 34.9; 50 | — |
| SECONDARY Health-related Quality of Life (HRQoL) EORTC QLQ-C30 Physical Functioning |
-6.7; -8.3; -20.0; -13.3; -13.3; -13.3 | — |
| SECONDARY HRQoL Questionnaire - EORTC QLQ-C30 Fatigue |
0; 0; 22.2; 0; 11.1; 5.6 | — |
| SECONDARY HRQoL Questionnaire - EORTC QLQ-C30 Nausea/Vomiting |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY HRQoL Questionnaire - EORTC QLQ-C30 Diarrhea |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY HRQoL Questionnaire - QLQ-BN20 Headache |
0; 0; 0; 0; -33.3; 0 | — |
| SECONDARY Number of Participants With Adverse Events |
35; 33; 39; 42 | — |
Eligibility Criteria
Inclusion Criteria
- Having radiologically proven brain metastases of lung cancer
- Having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays in one week. Treatment with enzastaurin must start within 14 days after the last fraction of the whole brain radiotherapy
- No other previous radiotherapy to the brain except for radiosurgery at one occasion
- Adequate organ function as measured by appropriate laboratory tests.
- Age 18 years or older.
Exclusion Criteria
- Inability to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction).
- Inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine, phenobarbital or phenytoin.
- Concurrent administration of warfarin
- Hemophilia
- Having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.
Data sourced from ClinicalTrials.gov (NCT00415363). 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.