Advanced MalignanciesPhase 1NCT01284192
Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)
A Phase 1 study testing ASP3026 in people with Advanced Malignancies and Positive for Anaplastic Lymphoma Kinase, run by Astellas Pharma Inc at 6 sites in United States.
Trial summary
This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase, Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS
- What is being tested?
- ASP3026
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2010to Mar 2016
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor or B-cell lymphoma and meets at least 1 of the following criteria:
- Disease progression despite standard therapies
- No standard therapies are available or such therapies are not anticipated to result in a durable response
- Standard therapies are considered unsuitable or have been refused
- Able to take oral medications
Show all 9Show fewer
- Life expectancy > 12 weeks
- For the expansion cohort of the study, all subjects must be confirmed to be positive for ALK gene abnormalities
- Subjects with stable brain metastasis will be allowed
Who cannot join
- Active central nervous system (CNS) metastases or leptomeningeal involvement as assessed through medical history review and physical examination (dose escalation subjects only)
- Known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
- Known hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection
- Cardiac arrhythmias > Grade 1 using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.03
- Class 3 or 4 New York Heart Association congestive heart failure, acute coronary syndrome, myocardial infarction or cerebrovascular accident within 6 months prior to Cycle 1, Day 1
- Inadequate bone marrow, renal, and/or hepatic function
- Confirmed active peptic ulcer disease or history of gastrointestinal bleeding within the past 3 months
- Known history of long QT syndrome
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Site US11
Chicago, Illinois, 60637
Site US2688
Detroit, Michigan, 48201
Site US2492
Houston, Texas, 77030
Site US160
Orange, California, 92868
Site US184
Sacramento, California, 95817
Site US1905
San Antonio, Texas, 78229
About this study
Official title: A Phase 1, Multicenter, Open-Label, Dose Escalation Study of ASP3026 in Subjects With Advanced Malignancies
This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma).
Read the detailed description
This study will be conducted using a traditional 3 + 3 dose escalation study design. Enrollment of at least 3 subjects is planned for each dosing cohort until the Maximum Tolerated Dose (MTD) is determined. Up to three additional subjects per cohort may be enrolled if each additional subject is known to be positive for Anaplastic Lymphoma Kinase (ALK) or Proto-Oncogene Tyrosine-Protein Kinase ROS (ROS) abnormalities. The decision to expand a cohort or dose escalate will be based on the occurrence of dose limiting toxicities (DLTs) in Cycle 1 that are considered by the Investigator to be related (possibly or probably) to ASP3026. Intra-subject dose escalation will be allowed at the discretion of the investigators. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Once the MTD is determined, approximately 20 additional subjects with Anaplastic Lymphoma Kinase (ALK) abnormalities will be enrolled at the Recommended Phase 2 Dose. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.
- Conditions
- Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase, Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS, Solid Tumor, B-Cell Lymphoma
- Being tested
- ASP3026
- Keywords
- B-cell Lymphoma, Advanced Malignancies, Anaplastic Lymphoma Kinase (ALK), ASP3026, Solid Tumor
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3026Drug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| ASP3026 | Experimental | Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD) Receives: Drug: ASP3026 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations
Measured: Up to 30 days after last subject discontinues treatment
Secondary outcomes (2)
Pharmacokinetic assessment through analysis of blood and urine samples
Measured: Up to Day 29
Objective response rate (ORR)
Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)
Measured: 30 Days after the last subject discontinues treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced MalignanciesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Medical Director, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284192
- Sponsor's protocol ID
- A3026-CL-0101
- Status last verified
- Jun 2016
- First submitted
- 25 Jan 2011
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Li T, LoRusso P, Maitland ML, Ou SH, Bahceci E, Ball HA, Park JW, Yuen G, Tolcher A. First-in-human, open-label dose-escalation and dose-expansion study of the safety, pharmacokinetics, and antitumor effects of an oral ALK inhibitor ASP3026 in patients with advanced solid tumors. J Hematol Oncol. 2016 Mar 10;9:23. doi: 10.1186/s13045-016-0254-5.
PubMed 26966027
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. 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 ASP3026 in Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01284192
- Acronym / sponsor ID
- A3026-CL-0101
- Conditions
- Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase, Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS, Solid Tumor, B-Cell Lymphoma
- Keywords
- B-cell Lymphoma, Advanced Malignancies, Anaplastic Lymphoma Kinase (ALK), ASP3026, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Jan 2011 (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.
This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma).
Detailed description
This study will be conducted using a traditional 3 + 3 dose escalation study design. Enrollment of at least 3 subjects is planned for each dosing cohort until the Maximum Tolerated Dose (MTD) is determined. Up to three additional subjects per cohort may be enrolled if each additional subject is known to be positive for Anaplastic Lymphoma Kinase (ALK) or Proto-Oncogene Tyrosine-Protein Kinase ROS (ROS) abnormalities. The decision to expand a cohort or dose escalate will be based on the occurrence of dose limiting toxicities (DLTs) in Cycle 1 that are considered by the Investigator to be related (possibly or probably) to ASP3026. Intra-subject dose escalation will be allowed at the discretion of the investigators. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Once the MTD is determined, approximately 20 additional subjects with Anaplastic Lymphoma Kinase (ALK) abnormalities will be enrolled at the Recommended Phase 2 Dose. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP3026 | Experimental | Drug: ASP3026Subjects will receive escalated doses of ASP3026 to determine the maximum tolerated dose (MTD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor or B-cell lymphoma and meets at least 1 of the following criteria:
- Able to take oral medications
- Life expectancy > 12 weeks
- For the expansion cohort of the study, all subjects must be confirmed to be positive for ALK gene abnormalities
Key exclusion criteria (8 listed)
- Active central nervous system (CNS) metastases or leptomeningeal involvement as assessed through medical history review and physical examination (dose escalation subjects only)
- Known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
- Known hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection
- Cardiac arrhythmias > Grade 1 using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.03
- Class 3 or 4 New York Heart Association congestive heart failure, acute coronary syndrome, myocardial infarction or cerebrovascular accident within 6 months prior to Cycle 1, Day 1
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 |
|---|---|---|
| ASP3026Tablet | Drug | ASP3026 |
Primary outcome
Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations
Time frame: Up to 30 days after last subject discontinues treatment
2 secondary outcomes
Pharmacokinetic assessment through analysis of blood and urine samples
Time frame: Up to Day 29
Objective response rate (ORR)
Time frame: 30 Days after the last subject discontinues treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Derived from this study: PubMed 26966027Li T, LoRusso P, Maitland ML, Ou SH, Bahceci E, Ball HA, Park JW, Yuen G, Tolcher A. First-in-human, open-label dose-escalation and dose-expansion study of the safety, pharmacokinetics, and antitumor effects of an oral ALK inhibitor ASP3026 in patients with advanced solid tumors. J Hematol Oncol. 2016 Mar 10;9:23. doi: 10.1186/s13045-016-0254-5.
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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.
Senior Medical Director study director
Astellas Pharma Global Development
6 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 ASP3026 in people with Advanced Malignancies and Positive for Anaplastic Lymphoma Kinase, run by Astellas Pharma Inc at 6 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations (time frame: Up to 30 days after last subject discontinues treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01284192, which also lists 1 linked publication.
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 28 Jun 2016.