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Brief Title: Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung
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
Study ID: NCT01561456
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
State Medical Institution: Republic Scientific Oncology Center, Poselok, Minsk Region, Belarus
Gomel Regional Clinical Oncology Center, Gomel, , Belarus
Minsk City Clinical Oncology Center, Minsk, , Belarus
Vitebsk Regional Clinical Oncology Center, Vitebsk, , Belarus
Semmelweis University; Clinic for Pulmonology, Budapest, , Hungary
University of Debrecen Medical and Health Science Center, Clinic of Pulmonology, Debrecen, , Hungary
Kenezy Gyula County Hospital, Debrecen, , Hungary
Hospital for Thoracic Diseases of Csongrad County Local Government, Deszk, , Hungary
Wladyslaw Bieganski Regional Specialist Hospital, Grudziadz, , Poland
Maria Sklodowska-Curie Institute of Oncology in Warsaw, Warsaw, , Poland
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncology Center, Chelyabinsk, , Russian Federation
Sverdlovsk Regional Oncology Center, Ekaterinburg, , Russian Federation
City Clinical Hospital #1, Novosibirsk, , Russian Federation
Orel Oncology Center, Orel, , Russian Federation
State Higher Educational Institution St. Petersburg State Medical University n. a. after I. P. Pavlov under Federal Agency for Healthcare and Social Development, Research Institute of Pulmonology, Saint Petersburg, , Russian Federation
St. Petersburg State Medical Institution Municipal Clinical Oncology Center, St. Petersburg, , Russian Federation
Tula Regional Oncology Center, Tula, , Russian Federation
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Dniepropetrovsk, , Ukraine
Public Clinical Treatment and Prophylaxis Institution: Donetsk Regional Antitumor Center, Donetsk, , Ukraine
Kharkiv, State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences, Kharkiv, , Ukraine
Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center, Kharkiv, , Ukraine
Kyiv City Oncology Hospital, Kyiv, , Ukraine
Lviv State Regional Treatment and Diagnostics Oncology Center, Lviv, , Ukraine
Zakarpattia Regional Clinical Oncology Center, Uzhhorod, , Ukraine
Name: Michael Bergqvist, MD, PhD
Affiliation: Uppsala University Hospital, Sweden
Role: PRINCIPAL_INVESTIGATOR