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 Anti-Cancer Agents & Biologic Therapy
Small-Cell Lung Cancer
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.