Squamous Cell Carcinoma Clinical Trial
Official title:
Phase II, Randomized, Open-label Study of the IGF-1R Inhibitor AXL1717 Compared to Docetaxel in Patients With Previously Treated, Locally Advanced, or Metastatic Squamous Cell Carcinoma or Adenocarcinoma of the Lung
The purpose of this study is to compare effectiveness and safety of experimental anticancer medicine, AXL1717, and docetaxel in patients with squamous cell carcinoma or adenocarcinoma of the lung.
Non-Small-Cell lung Cancer (NSCLC) is the most common form of lung cancer, and treatment
with cytotoxic chemotherapy only provides a 10% reduction in the risk of death in patients
with advanced NSCLC. One-third of all non-resectable advanced NSCLC patients in second line
do not receive chemotherapy treatment at all. In the absence of treatment the
Progression-Free Survival (PFS) for NSCLC patients is dismal, in the range of 6-8 weeks, and
treatment only modestly improves the median PFS to 10-11 weeks. Therefore, because of an
overall poorer prognosis for patients with advanced NSCLC, development of new agents is
urgently needed.
AXL1717 is a small molecule experimental product developed by Axelar AB as anticancer agent
for oral administration. AXL1717 inhibits the insulin-like growth factor 1 (IGF-1), which is
often over expressed in lung tumors and can mediate the proliferation of lung cancer cells
and resistance to therapy. Results of previous preclinical and clinical studies indicate
that AXL1717 will be tolerable and effective in patients with previously-treated, advanced
squamous cell carcinoma (SCC) and adenocarcinoma (AC) histological subtypes of NSCLC.
This is an open label, randomized, multi-center, Phase II study to investigate AXL1717
compared to docetaxel in patients with squamous cell carcinoma (SCC) or adenocarcinoma (AC)
of the lung. Patients with previously treated, locally advanced or metastatic SCC or AC
subtypes of NSCLC in need of additional treatment will be enrolled in the study. Patients
will be randomized to either AXL1717 or to docetaxel group as monotherapy, in a 3:2 ratio
for each NSCLC subtype. Patients in AXL1717 group will receive 400 mg AXL1717 twice daily
(BID) as oral suspension for 21 days per cycle; i.e. daily for up to four cycles unless a
dose interruption, delay, or reduction is required. Docetaxel will be administered as a
standard treatment (75 mg/m2 IV infusion over 1 hour) once every three weeks throughout the
4-cycle study. The primary objective of the study is to compare the rate of progression-free
survival (PFS) at 12 weeks between patients treated with AXL1717 and patients treated with
docetaxel. Additional efficacy and safety parameters will be monitored throughout the study.
Patients treated with AXL1717 who are responding to treatment or remain stable at the end of
4 cycles may be offered an extension of treatment with AXL1717.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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