Clinical Trials Logo

Clinical Trial Summary

Investigators propose to study the single agent activity of pazopanib in a Phase II trial of patients with relapsed or refractory small cell lung cancer. Because these patients have very limited treatment options, use of an investigational agent in this patient population is supported by current National Comprehensive Cancer Network guidelines. Using correlative biologic studies to evaluate the anti angiogenic activity of pazopanib in the absence of concomitant chemotherapy will allow us to delineate the responses due to this drug and the effect on angiogenesis.

Pazopanib dose has been determined to 800 mg once daily per the initial recommended dose approved by FDA and EMA, as monotherapy in advanced Renal Cell Carcinoma


Clinical Trial Description

Small cell lung cancer is a tumor that initially responds to chemotherapy and radiotherapy, however, it is associated with very poor prognosis since the initial response is nearly always followed by relapse and metastasis. The response to subsequent therapy is very limited as is the duration of response in these patients. Patients with SCLC have high rates of metastases at presentation suggesting that angiogenesis is particularly important in this cancer, furthermore studies have shown that microvessel density and VEGF expression in SCLC tumor samples correlate with development of metastases and poor prognosis. Furthermore VEGF expression was the only factor that retained a significant inverse correlation with survival when assessed in a multivariate analysis.

Pazopanib is a potent, small molecule competitive inhibitor of the tyrosine kinase activity of (VEGFR 1), VEGFR 2, VEGFR 3, platelet derived growth factor (PDGF), and c kit, capable of inhibiting downstream signalling from these receptors. The IC50 of pazopanib against VEGFR 2 is 10nm, and the IC50 against VEGFR 1 is <50nm. Currently a number of studies is underway for the evaluation of pazopanib in the treatment NSCLC. Administering pazopanib to patients with relapsed SCLC offers an attractive choice in patients with very limited therapeutic choices. The high rate of metastasis highlights the need for alternative treatments that act directly on the growth and invasion of tumors and subsequent development of metastases, rather than solely on cell proliferation. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01713296
Study type Interventional
Source Hellenic Oncology Research Group
Contact
Status Completed
Phase Phase 2
Start date November 2011
Completion date March 2015

See also
  Status Clinical Trial Phase
Completed NCT05026593 - A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer Phase 1
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT00046787 - Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung Cancer Phase 2
Recruiting NCT04826341 - A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors Phase 1/Phase 2
Recruiting NCT05655598 - TAS-116 Plus Palbociclib in Breast and Rb-null Cancer Phase 1
Withdrawn NCT04677361 - Feasibility Study on Expandion of MILs From NSCLC and SCLC Patients and Infusion With Pembrolizumab Early Phase 1
Terminated NCT00522639 - Predictive Value of FDG-PET-CT Scans for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation Phase 3
Completed NCT03428607 - Study of AZD6738 and Olaparib Combination Therapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N2] Phase 2
Recruiting NCT05546268 - Study of Oral MRT-2359 in Selected Cancer Patients Phase 1/Phase 2
Recruiting NCT06116019 - Online Adaptive Radiotherapy Using a Novel Linear Accelerator (ETHOS)
Not yet recruiting NCT03244904 - Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment N/A
Recruiting NCT04162041 - Topotecan Plus M6620 (VX-970) vs. Topotecan Alone in People With Relapsed Small-Cell Lung Cancer Phase 2
Recruiting NCT05130255 - GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2 Phase 1
Recruiting NCT04686682 - A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors Phase 1/Phase 2
Recruiting NCT02611024 - Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors Phase 1/Phase 2
Recruiting NCT05879068 - A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC Phase 2
Recruiting NCT04684017 - Anlotinib Plus Etoposide and Carboplatin as First-line Treatment for Extensive-stage Small Cell Lung Cancer Phase 2
Completed NCT00346385 - BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors Phase 1
Active, not recruiting NCT02734004 - A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. Phase 1/Phase 2