Solid TumorsPhase 1NCT00741234
A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
A Phase 1 study testing SB939 and Azacitidine in people with Solid Tumors and Hematologic Malignancies, run by S*BIO at 5 sites in 2 countries.
Trial summary
This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Hematologic Malignancies, Myelodysplastic Syndrome
- What is being tested?
- SB939 and Azacitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Apr 2007to Mar 2012
- 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
- Arms A \& B:
- Patients with solid tumors in Arm A and hematologic malignancies in Arm B that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
- ECOG performance status (PS) 0-2;
- Patients must have adequate non-hematologic organ system function.
- Arm C:
- Patients with MDS that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
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- Have not been treated with azacitidine and are a candidate for treatment with azacitidine;
- ECOG performance status (PS) 0-2;
- Patients must have adequate non-hematologic organ system function.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Singapore3 sites
National University Hospital
Singapore, 119074
National Cancer Center
Singapore, 160610
Singapore General Hospital
Singapore, 169608
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
Official title: A Phase I Dose Escalation Study of Oral SB939 When Administered Thrice Weekly (Every Other Day) for 3 Weeks in a 4-week Cycle in Patients With Advanced Malignancies
This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and tolerability of SB939 in combination with standard azacitidine therapy.
- Being tested
- SB939, Azacitidine
- Keywords
- SB939, Myelodysplastic Syndrome, Combination with azacitidine, Solid malignancies, Hematologic malignancies, HDAC inhibitor, Refractory to standard therapy
- Medical subject headings
- Hematologic Neoplasms, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB939Drug
SB939 taken orally in a 4-week cycle.
AzacitidineDrug
Also called Vidaza
Azacitidine taken orally with SB939 in a 4-week cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Advanced solid tumors Receives: Drug: SB939 |
| B | Experimental | Advanced hematologic malignancies Receives: Drug: SB939 |
| C | Experimental | Myelodysplastic Syndrome Receives: Drug: SB939; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of SB939, administered orally every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C).
Measured: Throughout the study
Secondary outcomes (5)
To establish the maximum tolerated dose and a recommended phase II dose of SB939 as a single agent when administered every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks
Measured: Throughout the study
To determine the dose limiting toxicities of SB939
Measured: Throughout the study
To determine the pharmacokinetic profile of SB939
Measured: Throughout the study
To assess histone acetylation in PBMC and other biomarkers
Measured: Throughout the study
To document anti-tumor activity
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startApr 2007
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- S*BIO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Wilding, M.D., Principal investigator, University of Wisconsin, MadisonBoon Cher Goh, M.D., Principal investigator, National University Hospital, SingaporeHan Chong Toh, M.D., Principal investigator, National Cancer CenterCharles Chuah, M.D., Principal investigator, Singapore General HospitalGuillermo Garcia-Manero, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741234
- Sponsor's protocol ID
- SB939-2006-001
- Status last verified
- Apr 2012
- First submitted
- 22 Aug 2008
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of Oral SB939 When Administered Thrice Weekly (Every Other Day) for 3 Weeks in a 4-week Cycle in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00741234
- Acronym / sponsor ID
- SB939-2006-001
- Keywords
- SB939, Myelodysplastic Syndrome, Combination with azacitidine, Solid malignancies, Hematologic malignancies, HDAC inhibitor, Refractory to standard therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- S*BIOIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Aug 2008 (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 an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and tolerability of SB939 in combination with standard azacitidine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: SB939Advanced solid tumors |
| B | Experimental | Drug: SB939Advanced hematologic malignancies |
| C | Experimental | Drug: SB939, Drug: AzacitidineMyelodysplastic Syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with solid tumors in Arm A and hematologic malignancies in Arm B that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
- ECOG performance status (PS) 0-2;
- Patients must have adequate non-hematologic organ system function.
- Patients with MDS that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
- Have not been treated with azacitidine and are a candidate for treatment with azacitidine;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SB939SB939 taken orally in a 4-week cycle. | Drug | A, B, C |
| AzacitidineAlso: VidazaAzacitidine taken orally with SB939 in a 4-week cycle | Drug | C |
Primary outcome
To assess the safety and tolerability of SB939, administered orally every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C).
Time frame: Throughout the study
5 secondary outcomes
To establish the maximum tolerated dose and a recommended phase II dose of SB939 as a single agent when administered every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks
Time frame: Throughout the study
To determine the dose limiting toxicities of SB939
Time frame: Throughout the study
To determine the pharmacokinetic profile of SB939
Time frame: Throughout the study
To assess histone acetylation in PBMC and other biomarkers
Time frame: Throughout the study
To document anti-tumor activity
Time frame: Throughout the study
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 23 Apr 2012.
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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.
George Wilding, M.D. principal investigator
University of Wisconsin, Madison
Boon Cher Goh, M.D. principal investigator
National University Hospital, Singapore
Han Chong Toh, M.D. principal investigator
National Cancer Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB939 and Azacitidine in people with Solid Tumors and Hematologic Malignancies, run by S*BIO at 5 sites in 2 countries.
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 0 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 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Singapore, 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 assess the safety and tolerability of SB939, administered orally every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C). (time frame: Throughout the study). 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 23 Apr 2012.