A Phase 1, Multicenter, Open-Label, Dose Escalation Study of ASP9853 in Combination With Either Docetaxel or Paclitaxel in Subjects With Advanced Non-hematologic Malignancies
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