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

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01705483 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-386

 

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.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Susan Pandya, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Linda Pointon, 617-632-4391, linda_pointon@dfci.harvard.edu
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

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 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
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