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 machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".