1478TiP - Phase 2 study of aldoxorubicin versus topetecan for relapsed/refractory small cell lung cancer

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer agents
Small Cell Lung Cancer
Therapy
Biological Therapy
Presenter Scott Wieland
Citation Annals of Oncology (2014) 25 (suppl_4): iv511-iv516. 10.1093/annonc/mdu355
Authors S. Wieland1, A. Mita2, S. Piantadosi2, R. Natale2, D. Levitt3
  • 1Clinical Operations, CytRx Corporation, 90049 - Los Angeles/US
  • 2Oncology/hematology, Cedars Sinai Medical Center, 90048 - Los Angeles/US
  • 3Clinical Development, CytRx Corporation, Los Angeles/US

Abstract

Background

Aldoxorubicin is a novel prodrug that binds to albumin in the circulation. Doxorubicin is cleaved in low pH environments, allowing administration of 3 1/2-4-fold higher doses than standard doxorubicin and 10-fold greater cumulative doses. Patients with metastatic small cell lung cancer (SCLC) who have failed prior chemotherapies have a poor prognosis with response rates (ORR) of 5-20%, progression-free surival (PFS) of 2-4 months and overall survival of 6-10 months. Topotecan is the standard therapy for these patients.

Trial design

Open label study, 132 patients, ( 1:1 randomization) to receive either aldoxorubicin (230 mg/m2, IV infusion, Day 1, every 3 weeks) or topotecan (either 2.3 mg/m2//day oral or 1.5 mg/m2/day IV, Days 1-5, every 3 weeks. Key inclusions: confirmed SCLC, relapsed or refractory to 1 prior chemo, ECOG 0-2, meaurable tumor (RECIST 1.1). Key exclusions: >375 mg/m2 prior doxorubicin, prior topotecan, active CNS mets, lab abnormalities (ANC<1500/mm3, platelets<100,000/mm3, Hgb<9 gm/dL, LFTs>3x or 5x (if liver mets) ULN), serious myocardial dysfunction. Key stratifications: relapse<90 days versus>90 days; ECOG 0-1 versus 2 Primary endpoint: PFS (analysis after 110 events); assume PFS for topotecan=3.5 months, aldoxorubicin=6.5 months. Secondary endpoints: ORR, OS, disease control rate, adverse events, tolerability, lab abnormalities. Study sites: Up to 35 sites in the US, Canada, Europe and Asia Pacific.

Disclosure

S. Wieland: Employee of CytRx Corporation; Salary and Stock Options; D. Levitt: Employee of CytRx Corporation; salary and stock options. All other authors have declared no conflicts of interest.