Solid TumorPhase 1NCT01401504
Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors
A Phase 1 study testing ASP3026 in people with Solid Tumor, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumor
- 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
- 29 participants
- Where
- 1 siteJapan
- Study dates
- May 2011to Jan 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 20 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
- Patient 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
- Life expectancy > 12 weeks
- Able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing
Who cannot join
- Patient exhibits persistent subjective and objective findings of toxicity ≥ Grade 2 (CTCAE v4.0-JCOG) from the previous cancer treatment with antitumor effect (except of alopecias)
- Received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing
- Patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study
- Use of an investigational drug or device within 21 days prior to the scheduled initial dosing
- Use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing
- A positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
- Known history of a positive test for human immunodeficiency virus (HIV) infection
- Patient has central nervous system (CNS) or leptomeningeal involvement with clinical symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Non-randomized, Open-label, Repeat Oral Administration Study of ASP3026 in Patients With Solid Tumors
A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).
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. 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. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.
The maximum tolerated dose (MTD) is defined as the highest dose of ASP3026 on a dosing schedule at which < 33% of subjects experience a DLT during Cycle 1. The MTD or lower dose, as determined by the Safety Data Review Committee, will be the recommended Phase 2 dose (RP2D). Twelve additional patients will be treated at the RP2D to further evaluate safety and tolerability.
- Conditions
- Solid Tumor
- Being tested
- ASP3026
- Keywords
- Anti-cancer, ASP3026, Anaplastic Lymphoma Kinase (ALK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3026Drug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP3026 | Experimental | Not described 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)
Pharmacokinetics of ASP3026 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) in plasma and urine
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 posted25 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401504
- Sponsor's protocol ID
- 3026-CL-0102
- Status last verified
- Jun 2014
- First submitted
- 30 Jun 2011
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ono A, Murakami H, Seto T, Shimizu T, Watanabe S, Takeshita S, Takeda K, Toyoshima J, Nagase I, Bahceci E, Morishita M, Morita S, Fukuoka M, Nakagawa K. Safety and Antitumor Activity of Repeated ASP3026 Administration in Japanese Patients with Solid Tumors: A Phase I Study. Drugs R D. 2021 Mar;21(1):65-78. doi: 10.1007/s40268-020-00331-2. Epub 2020 Dec 17.
PubMed 33331996Ono A, Murakami H, Serizawa M, Wakuda K, Kenmotsu H, Naito T, Taira T, Koh Y, Ohde Y, Nakajima T, Endo M, Takahashi T. Drastic initial response and subsequent response to two ALK inhibitors in a patient with a highly aggressive ALK-rearranged inflammatory myofibroblastic tumor arising in the pleural cavity. Lung Cancer. 2016 Sep;99:151-4. doi: 10.1016/j.lungcan.2016.07.002. Epub 2016 Jul 5.
PubMed 27565932
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Non-randomized, Open-label, Repeat Oral Administration Study of ASP3026 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01401504
- Acronym / sponsor ID
- 3026-CL-0102
- Conditions
- Solid Tumor
- Keywords
- Anti-cancer, ASP3026, Anaplastic Lymphoma Kinase (ALK)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 25 Jul 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.
A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).
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. 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. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met.
The maximum tolerated dose (MTD) is defined as the highest dose of ASP3026 on a dosing schedule at which < 33% of subjects experience a DLT during Cycle 1. The MTD or lower dose, as determined by the Safety Data Review Committee, will be the recommended Phase 2 dose (RP2D). Twelve additional patients will be treated at the RP2D to further evaluate safety and tolerability.
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: ASP3026 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status < 2.
- Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor
- Patient meets at least 1 of the following criteria:
- Life expectancy > 12 weeks
- Able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing
Key exclusion criteria (8 listed)
- Patient exhibits persistent subjective and objective findings of toxicity ≥ Grade 2 (CTCAE v4.0-JCOG) from the previous cancer treatment with antitumor effect (except of alopecias)
- Received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing
- Patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study
- Use of an investigational drug or device within 21 days prior to the scheduled initial dosing
- Use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing
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 |
|---|---|---|
| ASP3026oral | 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
Pharmacokinetics of ASP3026 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) in plasma and urine
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 11 Jun 2014.
- Derived from this study: PubMed 33331996Ono A, Murakami H, Seto T, Shimizu T, Watanabe S, Takeshita S, Takeda K, Toyoshima J, Nagase I, Bahceci E, Morishita M, Morita S, Fukuoka M, Nakagawa K. Safety and Antitumor Activity of Repeated ASP3026 Administration in Japanese Patients with Solid Tumors: A Phase I Study. Drugs R D. 2021 Mar;21(1):65-78. doi: 10.1007/s40268-020-00331-2. Epub 2020 Dec 17.
- Derived from this study: PubMed 27565932Ono A, Murakami H, Serizawa M, Wakuda K, Kenmotsu H, Naito T, Taira T, Koh Y, Ohde Y, Nakajima T, Endo M, Takahashi T. Drastic initial response and subsequent response to two ALK inhibitors in a patient with a highly aggressive ALK-rearranged inflammatory myofibroblastic tumor arising in the pleural cavity. Lung Cancer. 2016 Sep;99:151-4. doi: 10.1016/j.lungcan.2016.07.002. Epub 2016 Jul 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.
Use Central Contact study chair
Astellas Pharma Inc
1 site 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 Solid Tumor, run by Astellas Pharma Inc at 1 site in Japan.
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 8 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 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 NCT01401504, which also lists 2 linked publications.
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 11 Jun 2014.