Advanced CancerPhase 1NCT01423903
Phase 1, Open-label Trial to Determine Safety of OPB-51602 in Subjects With Advanced Cancer
A Phase 1 study testing OPB-51602 in people with Advanced Cancer, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given daily by mouth to subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- OPB-51602
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2010to Apr 2013
- 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
- Male or female subjects aged ≥ 18 years
- Pathologically confirmed advanced cancer that is resistant or refractory to standard therapy or for which no standard curative therapy is available
- At least 4 weeks since the last dose of prior chemotherapy, radiation therapy, or investigational agent.
- Subjects must have recovered from adverse effects of prior therapy at time of enrollment to ≤ Grade 1 (excluding alopecia)
- ECOG performance status ≤ 1
- Life expectancy of ≥ 3 months following study entry
Show all 17Show fewer
- Adequate organ function, defined as follows:
- Serum creatinine < 1.5 x the upper limit of normal (ULN)
- Aspartate aminotransferase and alanine aminotransferase levels ≤ 3.0 x ULN (≤ 5.0 x ULN in the presence of known liver metastasis)
- Total bilirubin ≤ 1.5 x ULN
- Alkaline phosphatase levels ≤ 2.5 x ULN (≤ 5 x ULN in presence of bone metastasis)
- Absolute neutrophil count of ≥ 1,500/mm³ (≥ 1.5 x 10⁹/L)
- Platelet count ≥ 100,000/mm³ (≥ 100 x10⁹/L)
- Hemoglobin ≥ 9 g/dL
- For women of childbearing potential (WOCBP), a negative serum pregnancy test result at screening and negative urine pregnancy test on Day 1
- WOCBP or men whose sexual partners are WOCBP must agree to use 2 methods of adequate contraception
- Before any protocol-specific screening procedures are performed, subjects must have signed and dated the IRB-approved ICF.
Who cannot join
- Uncontrolled concurrent illness, including ongoing or active infection, uncontrolled hypertension,or any other condition that could raise the subject's safety risk.
- Altered mental status, psychiatric illness, or social situation that could limit compliance with study requirements and/or confound interpretation of study results.
- Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C.
- Known brain metastasis that has not been treated and stable for at least 4 weeks, or subjects with leptomeningeal disease.
- Subjects unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with absorption of oral drugs.
- A history of major surgery within 28 days of first receipt of study drug. Subjects must have recovered fully from any surgery.
- Nursing or pregnant women
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in opinion of investigator, contraindicates use of an investigational drug, or that may render subject at excessively high risk for treatment complications.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Boston, Massachusetts, 02114
Study site
Nashville, Tennessee, 37203
Study site
Sarasota, Florida, 34232
About this study
Official title: Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once-Daily OPB-51602 in Subjects With Advanced Cancer
The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given daily by mouth to subjects with advanced solid tumors.
Read the detailed description
This study is based on data that support a role for the signal transducer and activator of transcription (STAT) family of proteins in oncogenesis. One of the mechanisms of action of OPB-51602 includes inhibition of STAT3 phosphorylation. Therefore OPB-51602 is expected to be active as an anti-cancer drug. This first-in-human study will characterize the safety profile of OPB-51602, evaluate the pharmacokinetics of OPB-51602, identify a recommended phase II dose, and obtain preliminary efficacy data, in subjects with advanced cancers for whom there is no standard treatment available.
- Conditions
- Advanced Cancer
- Being tested
- OPB-51602
- Keywords
- Phase I, STAT-3 inhibitor, solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPB-51602Drug
A cycle will consist of 28 days of OPB-51602 be taken by study subjects daily by mouth for every day of each 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| OPDC-51602 | Experimental | Subjects with advanced solid tumors will be treated with OPDC-51602 once daily by mouth Receives: Drug: OPB-51602 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of OPB-51602
AEs, vital signs, body weight, ECGs, clinical laboratory tests, and performance status will be assessed.
Measured: Weekly for first cycle, then every 2 weeks (on average up to 8 weeks).
Secondary outcomes (3)
To determine the pharmacokinetics of OPB-51602 and to determine the MTD of OPB-51602
The following PK parameters (Cmax, tmax, AUC₀-t, AUCtau, CLss/F and t½,z) will be determined using a non-compartmental approach for OPB-51602 and selected metabolites after single (Cycle 1, Day 1) and multiple daily doses (Cycle 2, Day 1).
Measured: 28 days
Pharmacodynamic profile:
Study drug effects on STAT-3 phosphorylation will be assessed in PBMCs of study subjects in the dose escalation and expansion stages.
Measured: 28 days
Antitumor effects:
Treatment response and/or disease progression in subjects with measurable disease will be evaluated after every 2 cycles using Response Evaluation Criteria in Solid Tumors (RECIST₉).
Measured: Every 2 cycles (on average 8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startFeb 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agnes Elekes, M.D., Study director, Otsuka Pharmaceutical Development & Commercialization, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423903
- Sponsor's protocol ID
- 266-09-202
- Status last verified
- Jan 2014
- First submitted
- 3 Aug 2011
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once-Daily OPB-51602 in Subjects With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01423903
- Acronym / sponsor ID
- 266-09-202
- Conditions
- Advanced Cancer
- Keywords
- Phase I, STAT-3 inhibitor, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 26 Aug 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.
The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given daily by mouth to subjects with advanced solid tumors.
Detailed description
This study is based on data that support a role for the signal transducer and activator of transcription (STAT) family of proteins in oncogenesis. One of the mechanisms of action of OPB-51602 includes inhibition of STAT3 phosphorylation. Therefore OPB-51602 is expected to be active as an anti-cancer drug. This first-in-human study will characterize the safety profile of OPB-51602, evaluate the pharmacokinetics of OPB-51602, identify a recommended phase II dose, and obtain preliminary efficacy data, in subjects with advanced cancers for whom there is no standard treatment available.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPDC-51602 | Experimental | Drug: OPB-51602Subjects with advanced solid tumors will be treated with OPDC-51602 once daily by mouth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female subjects aged ≥ 18 years
- Pathologically confirmed advanced cancer that is resistant or refractory to standard therapy or for which no standard curative therapy is available
- At least 4 weeks since the last dose of prior chemotherapy, radiation therapy, or investigational agent.
- Subjects must have recovered from adverse effects of prior therapy at time of enrollment to ≤ Grade 1 (excluding alopecia)
- ECOG performance status ≤ 1
Key exclusion criteria (8 listed)
- Uncontrolled concurrent illness, including ongoing or active infection, uncontrolled hypertension,or any other condition that could raise the subject's safety risk.
- Altered mental status, psychiatric illness, or social situation that could limit compliance with study requirements and/or confound interpretation of study results.
- Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C.
- Known brain metastasis that has not been treated and stable for at least 4 weeks, or subjects with leptomeningeal disease.
- Subjects unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with absorption of oral drugs.
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 |
|---|---|---|
| OPB-51602A cycle will consist of 28 days of OPB-51602 be taken by study subjects daily by mouth for every day of each 28 day cycle. | Drug | OPDC-51602 |
Primary outcome
To determine the safety and tolerability of OPB-51602
Time frame: Weekly for first cycle, then every 2 weeks (on average up to 8 weeks).
AEs, vital signs, body weight, ECGs, clinical laboratory tests, and performance status will be assessed.
3 secondary outcomes
To determine the pharmacokinetics of OPB-51602 and to determine the MTD of OPB-51602
Time frame: 28 days
Pharmacodynamic profile:
Time frame: 28 days
Antitumor effects:
Time frame: Every 2 cycles (on average 8 weeks).
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 15 Jan 2014.
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Agnes Elekes, M.D. study director
Otsuka Pharmaceutical Development & Commercialization, Inc.
3 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 OPB-51602 in people with Advanced Cancer, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 3 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 17 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 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
To determine the safety and tolerability of OPB-51602 (time frame: Weekly for first cycle, then every 2 weeks (on average up to 8 weeks).). 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 15 Jan 2014.