- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01705483
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
May 29, 2019 updated by: Astellas Pharma Global Development, Inc.
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
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.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48201
- Barbara Ann Karmanos Cancer Center
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: ASP9853 with docetaxel
2 docetaxel dose levels and starting dose of ASP9853 followed by escalation of ASP9853 with additional dose cohorts
|
oral
intravenous (IV)
Other Names:
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Experimental: Part 2: ASP9853 with paclitaxel
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
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oral
Taxol
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) physical examinations, and vital signs
Time Frame: Duration of study (24 months) to Final Study Visit, up to ≥ 30 days after last dose of ASP9853
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Duration of study (24 months) to Final Study Visit, up to ≥ 30 days after last dose of ASP9853
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) Profile for ASP9853: AUC24, AUClast, AUCinf, Cmax, Ctrough, tmax, t1/2, CL/F, and Vz/F
Time Frame: 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
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Area under the plasma concentration curve at 24 hours (AUC24), AUC from time zero to time of last measurable concentration (AUClast), AUC with the last concentration extrapolated to infinity (AUCinf), Maximum concentration (Cmax), Trough plasma concentration (Ctrough),Time to attain Cmax (Tmax), Apparent terminal elimination half-life (T1/2), Oral clearance (CL/F), and Volume of distribution during the terminal phase (Vz/F)
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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
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Pharmacokinetics (PK) Profile for Docetaxel: AUC24, AUClast, AUCinf, Cmax, tmax, t1/2, CL, and Vd ss
Time Frame: Part 1, Cycle 1, Day 1: Pre-dose and 9 times within the 24 hour period
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Clearance (CL), Distribution volume, steady state (Vd ss)
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Part 1, Cycle 1, Day 1: Pre-dose and 9 times within the 24 hour period
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Pharmacokinetics (PK) Profile for Paclitaxel: AUC24, AUClast, AUCinf, Cmax, tmax, t1/2, CL, and Vd ss
Time Frame: Part 2: Cycle 1: Day 1: Pre-dose and 9 times within the 24 hour period
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Part 2: Cycle 1: Day 1: Pre-dose and 9 times within the 24 hour period
|
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Objective response rate (ORR)
Time Frame: Treatment start to final Study Visit , up to 24 months
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The proportion of subjects with a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.1
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Treatment start to final Study Visit , up to 24 months
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Duration of response (DOR)
Time Frame: 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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2012
Primary Completion (Actual)
June 11, 2014
Study Completion (Actual)
June 11, 2014
Study Registration Dates
First Submitted
October 10, 2012
First Submitted That Met QC Criteria
October 10, 2012
First Posted (Estimate)
October 12, 2012
Study Record Updates
Last Update Posted (Actual)
May 30, 2019
Last Update Submitted That Met QC Criteria
May 29, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9853-CL-0101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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