Multiple MyelomaPhase 1NCT02978235
A Dose Finding Study Followed by a Safety and Efficacy Study for Patients With Multiple Myeloma or Lymphoma
A Phase 1 study testing TAS4464 in people with Multiple Myeloma and NonHodgkin Lymphoma, run by Taiho Oncology, Inc. at 7 sites in United States.
Trial summary
The Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, NonHodgkin Lymphoma
- What is being tested?
- TAS4464
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Mar 2017to 1 Feb 2018
- 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
- Provide written informed consent
- Women of child-bearing potential must have a negative pregnancy test
- Multiple Myeloma:
- Confirmed diagnosis of Multiple Myeloma with measurable disease, having been treated with at least two prior lines of therapy.
- Lymphoma:
- Confirmed diagnosis of Non-Hodgkin Lymphoma with measurable disease, having been treated with at least one anthracycline-based therapy, with relapse or progression since the last treatment received.
Who cannot join
- Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:
- Major surgery within 28 days
- Radiation/chemotherapy within 21 days
- Monoclonal antibodies within 28 days
- Corticosteroid administration >20 mg/day of prednisone or equivalent within 14 days
- Proteasome inhibitors within 14 days
Show all 14Show fewer
- Immunomodulatory agents within 7 days
- Stem cell transplant within 3 months
- Current immunosuppressive treatment for graft versus host disease
- Current use of an investigational agent
- Active graft versus host disease
- Known serious illness or medical condition
- Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class
- Pregnant or breast-feeding female
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Gabrail Cancer Center
Canton, Ohio, 44718
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
John Theurer Cancer Center at Hackensack Meridian Health
Hackensack, New Jersey, 07601
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Phase 1, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma
The Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma.
Read the detailed description
The trial was put on Clinical Hold prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law.
Background and Rationale:
- TAS4464 is an investigational NEDD8 activating enzyme (NAE) inhibitor, a compound which may affect cancer cell growth and survival. Thus, TAS4464 may help in the treatment of cancer.
Phase 1:
Primary:
- To investigate the safety and tolerability of TAS4464
- To identify a tolerated dose of TAS4464
Secondary:
- To investigate the preliminary efficacy of TAS4464
- To investigate the pharmacokinetics (PK) and the pharmacogenomics (PGx) of TAS4464
- To investigate the pharmacodynamics of TAS4464
- Conditions
- Multiple Myeloma, NonHodgkin Lymphoma
- Being tested
- TAS4464
- Keywords
- Multiple Myeloma, Relapsed/Refractory, Lymphoma, Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, Mantle Cell Lymphoma, MCL, Peripheral T-Cell Lymphoma, PTCL, TAS4464, NEDD8, NAE inhibitor, Neoplasms, Hematologic Diseases, Myeloma
- Medical subject headings
- Multiple Myeloma, Lymphoma, Non-Hodgkin, Recurrence, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, T-Cell, Peripheral, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS4464Drug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| TAS4464 | Experimental | Not described Receives: Drug: TAS4464 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing any dose-limiting toxicities, during dose escalation period, to determine maximum tolerated dose of TAS4464, using NCI CTCAE criteria, laboratory testing, performance status assessments, and other routine visit procedures
Measured: Completion of Cycle 1 (28 days)
Efficacy of TAS4464, defined as Objective Response Rate (ORR) per IWG criteria (NHL) and IMWG criteria (MM). This will take into consideration routine assessments including: imaging scans, physical exams, blood tests, urine tests and biopsy results
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start1 Mar 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Why it stopped: The trial was put on Clinical Hold and subsequently terminated prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978235
- Sponsor's protocol ID
- TAS-4464-101
- Status last verified
- Aug 2024
- First submitted
- 21 Nov 2016
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Safety, Pharmacokinetic and Efficacy Study of TAS4464 in Patients With Multiple Myeloma or Lymphoma
- ClinicalTrials.gov ID
- NCT02978235
- Acronym / sponsor ID
- TAS-4464-101
- Conditions
- Multiple Myeloma, NonHodgkin Lymphoma
- Keywords
- Multiple Myeloma, Relapsed/Refractory, Lymphoma, Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, DLBCL, Mantle Cell Lymphoma, MCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was put on Clinical Hold and subsequently terminated prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 30 Nov 2016 (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 Phase 1 portion of this study will determine the safety of TAS4464 and the most appropriate dose for patients with Multiple Myeloma or Lymphoma.
Detailed description
The trial was put on Clinical Hold prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law.
Background and Rationale:
- TAS4464 is an investigational NEDD8 activating enzyme (NAE) inhibitor, a compound which may affect cancer cell growth and survival. Thus, TAS4464 may help in the treatment of cancer.
Phase 1:
Primary:
- To investigate the safety and tolerability of TAS4464
- To identify a tolerated dose of TAS4464
Secondary:
- To investigate the preliminary efficacy of TAS4464
- To investigate the pharmacokinetics (PK) and the pharmacogenomics (PGx) of TAS4464
- To investigate the pharmacodynamics of TAS4464
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS4464 | Experimental | Drug: TAS4464 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written informed consent
- Women of child-bearing potential must have a negative pregnancy test
- Confirmed diagnosis of Multiple Myeloma with measurable disease, having been treated with at least two prior lines of therapy.
- Confirmed diagnosis of Non-Hodgkin Lymphoma with measurable disease, having been treated with at least one anthracycline-based therapy, with relapse or progression since the last treatment received.
Key exclusion criteria (14 listed)
- Any of the following treatments, within the specified time frame, prior to the first dose of TAS4464:
- Active graft versus host disease
- Known serious illness or medical condition
- Prior treatment with TAS4464 or known hypersensitivity to any of its inactive ingredients or drugs similar in class
- Pregnant or breast-feeding female
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 |
|---|---|---|
| TAS4464Intravenous (IV) Infusion | Drug | TAS4464 |
Primary outcome
Number of patients experiencing any dose-limiting toxicities, during dose escalation period, to determine maximum tolerated dose of TAS4464, using NCI CTCAE criteria, laboratory testing, performance status assessments, and other routine visit procedures
Time frame: Completion of Cycle 1 (28 days)
Efficacy of TAS4464, defined as Objective Response Rate (ORR) per IWG criteria (NHL) and IMWG criteria (MM). This will take into consideration routine assessments including: imaging scans, physical exams, blood tests, urine tests and biopsy results
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: The trial was put on Clinical Hold and subsequently terminated prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 TAS4464 in people with Multiple Myeloma and NonHodgkin Lymphoma, run by Taiho Oncology, Inc. at 7 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 6 inclusion and 14 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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: The trial was put on Clinical Hold and subsequently terminated prior to Phase 2 due to cases of drug induced liver injury meeting the criteria for Hy's Law). 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?
Number of patients experiencing any dose-limiting toxicities, during dose escalation period, to determine maximum tolerated dose of TAS4464, using NCI CTCAE criteria, laboratory testing, performance status assessments, and other routine visit procedures (time frame: Completion of Cycle 1 (28 days)). The study lists 2 primary outcomes in all. 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 5 Sep 2024.