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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 CenterBoston, Massachusetts  02215
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Sarah Cannon Research InstituteNashville, Tennessee  37203
Barbara Ann Karmanos Cancer CenterDetroit, Michigan  48201