Advanced CancersPhase 1/2NCT01563302
Phase 1/2, Open-label, Dose-escalation Study of IONIS-STAT3Rx, Administered to Patients With Advanced Cancers
A Phase 1/2 study testing IONIS-STAT3Rx in people with Advanced Cancers and DLBCL, run by Ionis Pharmaceuticals, Inc. at 9 sites in United States.
Trial summary
This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers, DLBCL, Lymphoma
- What is being tested?
- IONIS-STAT3Rx
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 9 sitesUnited States
- Study dates
- 27 Feb 2012to 23 Mar 2016
- Phase
- Phase 1/2
- 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
- Aged 18 years or older
- Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists
- Expansion cohort only: Advanced lymphoma confirmed by histopathology
- Measurable or evaluable disease according to RECIST for solid tumors or according to IWRC for NHL tumors
- ECOG Performance Status less than or equal to 2
- Life expectancy greater than 12 weeks in the opinion of the Investigator
Who cannot join
- Any active or uncontrolled infection
- NYHA Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months prior to screening
- Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Blood and Marrow Transplant Group of Georgia at Northside Hospital
Atlanta, Georgia, 30342
Northwestern University
Chicago, Illinois, 60611
Mary Crowley Cancer Research Centers
Dallas, Texas, 75201
MD Anderson Cancer Center
Houston, Texas, 77030
Moores UC San Diego Cancer Center
La Jolla, California, 92093
Yale Cancer Center
New Haven, Connecticut, 06510
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers
This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.
- Conditions
- Advanced Cancers, DLBCL, Lymphoma
- Being tested
- IONIS-STAT3Rx
- Keywords
- Advanced Cancers, DLBCL, Advanced Lymphoma
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IONIS-STAT3RxDrug
Also called ISIS 481464
Three-hour IV infusions on Cycle 0 Days 1, 3, 5, and weekly three-hour IV infusions in Cycles 1 and beyond, on Days 1, 8, and 15 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | IONIS-STAT3Rx Receives: Drug: IONIS-STAT3Rx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of IONIS-STAT3Rx in patients with Advanced Cancers
Measured: Approximately 28 days after last dose of IONIS -STAT3Rx
Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.
Highest dose level at which no more than 1 out of 6 patients develops a DLT
Measured: Approximately 28 Days
Secondary outcomes (4)
Clinical activity of IONIS-STAT3Rx
Measured by RECIST in the study population who have measurable disease or relevant disease specific response criteria
Measured: Approximately 28 Days after last dose of IONIS-STAT3Rx
Pharmacokinetics-Cmax
Maximum observed drug concentration (Cmax)
Measured: Approximately 28 days after last dose of IONIS-STAT3Rx
STAT3 and other biomarkers
The effect of treatment with IONIS-STAT3Rx on phospho-STAT3 and other biomarkers
Measured: Approximately 28 days after last dose of IONIS-STAT3Rx
Pharmacokinetics - Tmax
Time taken to reach Cmax
Measured: Approximately 28 days after last dose of IONIS-STAT3Rx
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study start27 Feb 2012
- Primary completion23 Mar 2016
- Study completion23 Mar 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 CancersStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Steve Hughes, MD, Study director, Ionis Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563302
- Sponsor's protocol ID
- ISIS 481464-CS1
- Status last verified
- Jun 2018
- First submitted
- 13 Feb 2012
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Reilley MJ, McCoon P, Cook C, Lyne P, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Fowler N, Curran M, Liu Q, Zhou T, Schmidt J, Jo M, Lee SJ, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella MVP, Xiao X, Hsu J, Revenko A, Monia BP, MacLeod AR, Hong DS. STAT3 antisense oligonucleotide AZD9150 in a subset of patients with heavily pretreated lymphoma: results of a phase 1b trial. J Immunother Cancer. 2018 Nov 16;6(1):119. doi: 10.1186/s40425-018-0436-5.
PubMed 30446007
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers
- ClinicalTrials.gov ID
- NCT01563302
- Acronym / sponsor ID
- ISIS 481464-CS1
- Conditions
- Advanced Cancers, DLBCL, Lymphoma
- Keywords
- Advanced Cancers, DLBCL, Advanced Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 27 Feb 2012 (actual)
- Primary completion
- 23 Mar 2016 (actual)
- Study completion
- 23 Mar 2016 (actual)
- First posted
- 26 Mar 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.
This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: IONIS-STAT3RxIONIS-STAT3Rx |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older
- Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists
- Expansion cohort only: Advanced lymphoma confirmed by histopathology
- Measurable or evaluable disease according to RECIST for solid tumors or according to IWRC for NHL tumors
- ECOG Performance Status less than or equal to 2
Key exclusion criteria (4 listed)
- Any active or uncontrolled infection
- NYHA Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months prior to screening
- Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter
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 |
|---|---|---|
| IONIS-STAT3RxAlso: ISIS 481464Three-hour IV infusions on Cycle 0 Days 1, 3, 5, and weekly three-hour IV infusions in Cycles 1 and beyond, on Days 1, 8, and 15 of each cycle. | Drug | Group 1 |
Primary outcome
Safety of IONIS-STAT3Rx in patients with Advanced Cancers
Time frame: Approximately 28 days after last dose of IONIS -STAT3Rx
Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.
Time frame: Approximately 28 Days
Highest dose level at which no more than 1 out of 6 patients develops a DLT
4 secondary outcomes
Clinical activity of IONIS-STAT3Rx
Time frame: Approximately 28 Days after last dose of IONIS-STAT3Rx
Pharmacokinetics-Cmax
Time frame: Approximately 28 days after last dose of IONIS-STAT3Rx
STAT3 and other biomarkers
Time frame: Approximately 28 days after last dose of IONIS-STAT3Rx
Pharmacokinetics - Tmax
Time frame: Approximately 28 days after last dose of IONIS-STAT3Rx
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 25 Jun 2018.
- Derived from this study: PubMed 30446007Reilley MJ, McCoon P, Cook C, Lyne P, Kurzrock R, Kim Y, Woessner R, Younes A, Nemunaitis J, Fowler N, Curran M, Liu Q, Zhou T, Schmidt J, Jo M, Lee SJ, Yamashita M, Hughes SG, Fayad L, Piha-Paul S, Nadella MVP, Xiao X, Hsu J, Revenko A, Monia BP, MacLeod AR, Hong DS. STAT3 antisense oligonucleotide AZD9150 in a subset of patients with heavily pretreated lymphoma: results of a phase 1b trial. J Immunother Cancer. 2018 Nov 16;6(1):119. doi: 10.1186/s40425-018-0436-5.
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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.
Steve Hughes, MD study director
Ionis Pharmaceuticals, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IONIS-STAT3Rx in people with Advanced Cancers and DLBCL, run by Ionis Pharmaceuticals, Inc. at 9 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 4 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 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 of IONIS-STAT3Rx in patients with Advanced Cancers (time frame: Approximately 28 days after last dose of IONIS -STAT3Rx). 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?
On the ClinicalTrials.gov record for NCT01563302, 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 25 Jun 2018.