Phase II study of the efficacy and safety of intravenous (IV) AVE0005 (VEGF Trap) given every 2 weeks in patients (Pts) with platinum- and erlotinib- resistant adenocarcinoma of the lung (NSCLA)
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
7627 Background: AVE0005 (VEGF Trap) is a recombinant fusion molecule of the human VEGF receptor extracellular domains and the F c portion of human IgG 1 . Methods: This is an open-label, single arm, multi-center trial employing a Simon 2-stage design. A total of 94 pts are planned. Three responses in the first 37 evaluable pts are required to progress to the second stage. IV AVE0005 (VEGF Trap) 4.0 mg/kg is given every 2 weeks to pts with platinum- and erlotinib-resistant, locally advanced or metastatic NSCLA. Other eligibility requirements include prior treatment with at least two cancer drug regimens in the advanced disease treatment setting, measurable disease, and ECOG performance status (PS) =2. Exclusions include squamous-cell lung cancer, prior treatment with a VEGF or VEGF receptor inhibitor with the exception of bevacizumab, history of brain metastasis, significant bleeding diathesis. End points are objective response rate, safety profile, duration of response, progression-free survival, overall survival and quality of life. Results: The study is ongoing and response and safety data are available for 33 pts (median age=60; males/females=14/19; ECOG PS 0/1/2=6/26/1 pts). A total of 132 cycles have been administered (median=4). Most common reason for withdrawal was progressive disease. Grade 3–4 treatment emergent adverse events (TEAEs) included (pts/percent) dyspnea (5/15%), hypertension and non-cardiac chest pain (3 pts each/9 %) fatigue (2/6 %), and anxiety, epistaxis, nausea, bone pain, proteinuria, febrile neutropenia, pneumonia, pulmonary embolism, and renal pain (1 each/3%). No grade 3 or greater hemoptysis has occurred. Two partial responses (PRs) have been reported to date. Conclusions: AVE0005 (VEGF Trap) 4 mg/kg IV has shown to be generally well tolerated; no significant hemoptysis has been seen to date. Single agent activity has been observed in this heavily treated population; interim futility analysis is awaited. The safety and preliminary activity profile supports further investigation with other targeted agents and cytotoxic chemotherapy. [Table: see text]
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| 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 it