a phase 1, dose escalation study to assess the safety and tolerability of asp9853 with either docetaxel or paclitaxel in patients with advanced non-hematologic malignancies

Conditions: Pharmacokinetics of ASP9853; Non-hematologic Malignancies

Summary: the purpose of this study is to determine the safety and tolerability and pharmacokinetics of asp9853 combined with docetaxel or with paclitaxel in subjects with advanced non-hematologic malignancies.

this is a two part study. part 1 will test increasing dose levels of asp9853 in combination with docetaxel. part 2 will test increasing doses of asp9853 combined with paclitaxel. each part will determine the maximum tolerated dose and recommended phase 2 dose for asp9853 in combination with each taxane. preliminary evidence of antitumor activity of asp9853 in combination with docetaxel or with paclitaxel also will be explored.

Eligibility criteria:
inclusion criteria: * subject must have a histologically or cytologically confirmed incurable, locally advanced, or metastatic non-hematologic malignancy that has progressed or failed to respond to regimens or therapies known to provide clinical benefit * subject must have an eastern cooperative oncology group (ecog) performance status ≤ 1 * subject must have recovered from the effects of prior systemic antineoplastic or radiation therapy(s) to ≤ grade 1 severity or to subject's baseline values, excluding alopecia * subject agrees not to participate in another interventional study while on treatment female subject must be either: of non child bearing potential: * post-menopausal (defined as at least 1 year without any menses) prior to screening or * documented surgically sterile or status post hysterectomy (at least 1 month prior to screening) or, if of childbearing potential: * must have a negative serum pregnancy test at screening and * must use two forms of birth control (at least one of which must be a barrier method) starting at screening and throughout the study period and for 28 days after final study drug administration acceptable forms include: * established use of oral, injected or implanted hormonal methods of contraception. * placement of an intrauterine device (iud) or intrauterine system (ius). * barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal * foam/gel/film/cream/suppository * female subject must not donate ova starting at screening and throughout the study period and for 28 days after final study drug administration. * male subject must not donate sperm starting at screening and throughout the study period and for 28 days after final study drug administration. * subject with adequate bone marrow, renal, and hepatic function at baseline exclusion criteria: * subject has received more than 3 prior cytotoxic agent-containing regimens * subjects with prior anaphylactic or hypersensitivity reaction to prior taxane therapy * subject with symptomatic central nervous system (cns) metastases or leptomeningeal involvement * subjects who received treatments with any of the following: * systemic chemotherapy within 21 days * nitrosoureas or mitomycin c within 42 days * radiotherapy to ≥ 25% of hematopoietically active bone marrow within 21 days * subject had major surgical procedure within 28 days or anticipates need for major surgical procedure during course of the study * female subjects who are breastfeeding at screening or during the study period and for 28 days after final study drug administration. * subject with peripheral neuropathy \> grade 1 at baseline * subject with known hepatitis b surface antigen (hbsag) positive status; or known or suspected active hepatitis c infection; or known human immunodeficiency virus (hiv) positive * subject with malabsorption syndrome or disease or condition significantly affecting gastrointestinal function * subject with significant or uncontrolled cardiac, renal, hepatic or other systemic disorders, or significant psychological conditions at baseline * subject with clinically significant electrocardiogram (ecg) abnormalities on 12 lead ecg performed within 14 days before start of study drug * subject who has received strong inhibitors or inducers of cyp3a4 within two weeks prior to start of study treatment and while on study * subject has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives, whichever is longer, prior to the initiation of screening

Keywords: asp9853 docetaxel paclitaxel