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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pharmacokinetics of ASP9853, Non-hematologic Malignancies

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) physical examinations, and vital signs

Outcome Time Frame:

Duration of study (24 months) to Final Study Visit, up to ≥ 30 days after last dose of ASP9853

Safety Issue:

No

Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

9853-CL-0101

NCT ID:

NCT01705483

Start Date:

August 2012

Completion Date:

September 2014

Related Keywords:

  • Pharmacokinetics of ASP9853
  • Non-hematologic Malignancies
  • ASP9853
  • Docetaxel
  • Paclitaxel
  • Neoplasms

Name

Location

Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana Farber Cancer Institute Boston, Massachusetts  02115
Sarah Cannon Research Institute Nashville, Tennessee  37203
Barbara Ann Karmanos Cancer Center Detroit, Michigan  48201