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

NCT01705483 | Terminated Phase 1

• 1 other identifier: 9853-CL-0101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Pharmacokinetics of ASP9853; Non-hematologic Malignancies

Keywords

ASP9853; Docetaxel; Paclitaxel

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (5)

• Pharmacokinetics (PK) Profile for ASP9853: AUC24, AUClast, AUCinf, Cmax, Ctrough, tmax, t1/2, CL/F, and Vz/F

  Parts 1 and 2, Cycle 1, Day 1: Pre-dose and 9 times within the 24 hour period following ASP9853 dosing; Days 8 and 15: pre-dose, Cycles 2 + , Day 1: predose

• Pharmacokinetics (PK) Profile for Docetaxel: AUC24, AUClast, AUCinf, Cmax, tmax, t1/2, CL, and Vd ss

  Part 1, Cycle 1, Day 1: Pre-dose and 9 times within the 24 hour period

• Pharmacokinetics (PK) Profile for Paclitaxel: AUC24, AUClast, AUCinf, Cmax, tmax, t1/2, CL, and Vd ss

  Part 2: Cycle 1: Day 1: Pre-dose and 9 times within the 24 hour period

• Objective response rate (ORR)

  Treatment start to final Study Visit , up to 24 months

• Duration of response (DOR)

  CR or PR response until last study visit at which a tumor assessment or an assessment of clinical disease progression is performed, up to 24 months

Study Arms (2)

Part 1: ASP9853 with docetaxel

EXPERIMENTAL

2 docetaxel dose levels and starting dose of ASP9853 followed by escalation of ASP9853 with additional dose cohorts

Drug: ASP9853; Drug: Docetaxel

Part 2: ASP9853 with paclitaxel

EXPERIMENTAL

Starting dose for ASP9853 determined as one dose level below maximum tolerated dose (MTD) determined in Part 1, 2 paclitaxel dose levels and starting dose of ASP9853 followed by escalation of ASP9853 with additional dose cohorts

Drug: ASP9853; Drug: Paclitaxel

Interventions

ASP9853 DRUG

oral

Part 1: ASP9853 with docetaxel; Part 2: ASP9853 with paclitaxel

Docetaxel DRUG

intravenous (IV)

Also known as: Taxotere

Part 1: ASP9853 with docetaxel

Paclitaxel DRUG

Taxol

Also known as: intravenous (IV)

Part 2: ASP9853 with paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (4)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Interventions

ASP9853; Docetaxel; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 12, 2012
• Study Start: August 28, 2012
• Primary Completion: June 11, 2014
• Study Completion: June 11, 2014
• Last Updated: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)