Pharmacokinetics of ASP9853Phase 1NCT01705483
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
A Phase 1 study testing ASP9853, Docetaxel and Paclitaxel in people with Pharmacokinetics of ASP9853 and Non-hematologic Malignancies, run by Astellas Pharma Global Development, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics of ASP9853, Non-hematologic Malignancies
- What is being tested?
- ASP9853, Docetaxel and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Aug 2012to 11 Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, 48201
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: 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.
Read the 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.
- Being tested
- ASP9853, Docetaxel, Paclitaxel
- Keywords
- ASP9853, Docetaxel, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP9853Drug
oral
DocetaxelDrug
Also called Taxotere
intravenous (IV)
PaclitaxelDrug
Also called intravenous (IV)
Taxol
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ASP9853 with docetaxel | Experimental | 2 docetaxel dose levels and starting dose of ASP9853 followed by escalation of ASP9853 with additional dose cohorts Receives: 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 Receives: Drug: ASP9853; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by recording of adverse events, clinical laboratory evaluation, electrocardiograms (ECGs) physical examinations, and vital signs
Measured: 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
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)
Measured: 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
Clearance (CL), Distribution volume, steady state (Vd ss)
Measured: 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
Measured: Part 2: Cycle 1: Day 1: Pre-dose and 9 times within the 24 hour period
Objective response rate (ORR)
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
Measured: Treatment start to final Study Visit , up to 24 months
Duration of response (DOR)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study start28 Aug 2012
- Primary completion11 Jun 2014
- Study completion11 Jun 2014
Why it stopped: Based on the results of the Phase 1 data, the company decided not to pursue the development of this drug at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of ASP9853Studies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705483
- Sponsor's protocol ID
- 9853-CL-0101
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2012
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01705483
- Acronym / sponsor ID
- 9853-CL-0101
- Keywords
- ASP9853, Docetaxel, Paclitaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the results of the Phase 1 data, the company decided not to pursue the development of this drug at this time.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2012 (actual)
- Primary completion
- 11 Jun 2014 (actual)
- Study completion
- 11 Jun 2014 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: ASP9853 with docetaxel | Experimental | Drug: ASP9853, Drug: Docetaxel2 docetaxel dose levels and starting dose of ASP9853 followed by escalation of ASP9853 with additional dose cohorts |
| Part 2: ASP9853 with paclitaxel | Experimental | Drug: ASP9853, Drug: PaclitaxelStarting 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- post-menopausal (defined as at least 1 year without any menses) prior to Screening or
Key exclusion criteria (16 listed)
- 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:
- Subject had major surgical procedure within 28 days or anticipates need for major surgical procedure during course of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP9853oral | Drug | Part 1: ASP9853 with docetaxel, Part 2: ASP9853 with paclitaxel |
| DocetaxelAlso: Taxotereintravenous (IV) | Drug | Part 1: ASP9853 with docetaxel |
| PaclitaxelAlso: intravenous (IV)Taxol | Drug | Part 2: ASP9853 with paclitaxel |
Primary outcome
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
5 secondary outcomes
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
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
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
Objective response rate (ORR)
Time frame: Treatment start to final Study Visit , up to 24 months
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
Results and safety
The study was stopped early (reason given: Based on the results of the Phase 1 data, the company decided not to pursue the development of this drug at this time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP9853, Docetaxel and Paclitaxel in people with Pharmacokinetics of ASP9853 and Non-hematologic Malignancies, run by Astellas Pharma Global Development, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on the results of the Phase 1 data, the company decided not to pursue the development of this drug at this time.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.