ATCT-22NRG ONCOLOGY/RTOG 1122: PHASE II DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF BEVACIZUMAB WITH OR WITHOUT AMG 386 IN PATIENTS WITH RECURRENT GLIOBLASTOMA OR GLIOSARCOMA
Bibliographic record
Abstract
Angiopoietins may play a role in mediating resistance to anti-VEGF therapy in glioblastoma (GBM). AMG 386 is a novel Fc fusion protein that sequesters angiopoietins Ang1 and Ang2. This is a phase II, double-blinded, placebo-controlled trial examining the efficacy of bevacizumab (Bev) 10 mg/kg every 2 weeks + AMG 386 15 mg/kg every week compared to Bev + placebo in Bev-naïve patients with recurrent GBM. The initial 6-patient lead-in cohort examined the safety of combining Bev + AMG 386. No more than 1 of the 6 eligible patients in the safety cohort experienced a DLT, and therefore the study proceeded. Patients ≥ 18 yrs with KPS ≥ 70 and GBM or variant in first or second relapse were randomized to Bev + placebo or Bev + AMG 386. The primary endpoint was 6-month progression-free survival (PFS6). Secondary endpoints included safety, radiographic response, progression free survival, and overall survival. 114 eligible patients were needed to yield an 85% statistical power to detect a projected absolute difference of 19% on PFS6 rate (AMG 386 arm vs. placebo arm: 55% vs. 36%) at a one-sided significance level of 0.15, based on a two-sample test on proportion. For the analysis on the primary endpoint, MRI or CT scans obtained at baseline, best response, and progression or 6 months after treatment started (if not progressed within 6 months) were collected for each patient for central radiology review. RANO response criteria were used for all efficacy determinations. Accrual on study was completed in 9/2014. Updated results for all 114 eligible patients will be presented. This project was supported by grants U10CA21661, U10CA180868, U10CA180822, U10CA37422, and UG1CA189867 from the National Cancer Institute (NCI) and Amgen.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".