Phase I clinical trial of AXL1717 for treatment of relapsed malignant astrocytomas: analysis of dose and response.

Purpose: Early phase I study of safety of AXL1717 in patients with recurrent or progressive malignant astrocytomas and evaluation of preliminary anti-tumor efficacy.

Patients And Methods: Nine patients fulfilling the set criteria were enrolled. Eight had recurrent glioblastoma and one gliosarcoma.

Phase II randomized study of the IGF-1R pathway modulator AXL1717 compared to docetaxel in patients with previously treated, locally advanced or metastatic non-small cell lung cancer.

Background: The primary objective of this study was to compare the progression-free survival (PFS) at 12 weeks between patients treated with IGF-1R pathway modulator AXL1717 (AXL) and patients treated with docetaxel (DCT).

Material And Methods: The study was conducted at 19 study centers in five countries. A total of 99 patients with previously treated, locally advanced or metastatic non-small cell lung cancer (NSCLC) of the squamous cell carcinoma (SCC) or adenocarcinoma (AC) subtypes in need of additional treatment were randomized and treated with either 300 or 400 mg of AXL as daily BID treatment (58 patients) or DCT given as 75 mg/m in three-week cycles (41 patients) as monotherapy in a 3:2 ratio for each NSCLC subtype.

A phase I pilot study of the insulin-like growth factor 1 receptor pathway modulator AXL1717 in combination with gemcitabine HCl and carboplatin in previously untreated, locally advanced, or metastatic non-small cell lung cancer.

AXL1717 is an orally bioavailable IGF-1R pathway modulator that has been shown to have anti-tumoral effects. The objectives of the present study were to define maximum tolerated dose and the recommended phase II dose (RPTD) of AXL1717 in combination with gemcitabine HCl and carboplatin in non-small cell lung cancer (NSCLC). Patients with previously untreated, locally advanced, or metastatic NSCLC (squamous cell cancer or adenocarcinoma) in good performance status and with preserved major organ functions were enrolled in the study.

Comparison between direct humidification and nebulization of the respiratory tract at mechanical ventilation: distribution of saline solution studied by gamma camera.

Aim: To study the effectiveness of this procedure, an intra-individual pilot study comparing the distribution of an instilled radiolabelled saline solution and an inhaled nebulized radiolabelled saline solution was performed using a scintigraphic technique.

Background: In patients treated with mechanical ventilation, we have routinely used instillation of saline solution in the endotracheal tube before suctioning with the aim of softening mucus and facilitating removal of secretions. In our experience, the effectiveness of this procedure is doubtful.