Metastatic SarcomaPhase 2IND200NCT01112384
A Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas
A Phase 2 study testing SB939 in people with Metastatic Sarcoma, run by NCIC Clinical Trials Group at 8 sites in Canada.
Trial summary
The purpose of this study is to find out what effects a new drug SB939 has on you and your sarcoma. This research is being done because there is a need for better treatment options for advanced or recurring sarcoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Metastatic Sarcoma
- What is being tested?
- SB939
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesCanada
- Study dates
- 21 Oct 2010to 16 Jan 2014
- Phase
- Phase 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically diagnosed sarcomas that are associated with chromosomal translocation producing a fusion transcription factor oncogene.
- Patients must have measurable disease.
- A tissue block from primary or metastatic tumor must be available for confirmation of diagnosis, translocation subtype and correlative studies.
- Up to 1 prior chemotherapy regimen in the metastatic setting is permitted providing 28 days have elapsed.
- Prior radiation permitted provided a minimum of 28 days have elapsed.
- Surgery permitted provided at least 3 weeks have elapsed.
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- Prior hormone therapy permitted.
- Patients must have life expectancy ≥ 12 weeks.
- Metastatic or locally recurrent disease incurable with standard treatment.
- Acceptable end-organ function. ECOG 0, 1 or 2.
- granulocytes ≥1.5x10/9/L
- platelets ≥100x10/9/L
- bilirubin ≤UNL
- potassium ≤UNL
- calcium, magnesium within normal limits
- AST, ALT ≤2.5 x UNL
- serum creatinine ≤UNL or creatinine clearance ≥50mL/min
- QTc ≤450m sec
- LVEF ≥50%
- Troponin I or T ≤ UNL
Who cannot join
- Cardiac exclusions; Patients with any preexisting uncontrolled cardiac condition.
- History of myocardial infarction at any time in the past.
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 5 years.
- Patients with documented CNS metastases, unless adequately treated with radiation at least 30 days prior to enrollment. Patients cannot have concurrent anti-convulsants or dexamethasone for control of symptoms. Patients with leptomeningeal disease, even with treatment, cannot be enrolled due to generally poor prognosis.
- Inability to take oral medication. Patients must be able to swallow SB939 capsules and have no gastrointestinal abnormalities (e.g. bowel obstruction or previous gastric resection) which would lead to inadequate absorption of SB939.
- Previous treatment with an HDAC inhibitor.
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- Treatment with another investigational therapy or other anticancer therapy within 28 days prior to study entry.
- Known HIV, hepatitis B or hepatitis C infections.
- Dysrhythmic drugs - use of agents with a known risk of Torsades De Pointe is not permitted during the study. A comprehensive list can be found at http://torsades.org.
- Presence of any chronic medical condition or comorbidity such as pulmonary disease, active CNS disease, active infection, psychiatric condition, or laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results.
- Women or men who are not sterile unless they use an adequate method of birth control. Female patients that are post-menopausal for at least 12 months or are surgically sterile are considered sterile.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
London Regional Cancer Program
London, Ontario, N6A 4L6
McGill University - Dept. Oncology
Montreal, Quebec, H2W 1S6
Ottawa Health Research Institute - General Division
Ottawa, Ontario, K1H 8L6
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase II Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas
The purpose of this study is to find out what effects a new drug SB939 has on you and your sarcoma.
This research is being done because there is a need for better treatment options for advanced or recurring sarcoma.
SB939 has been shown to shrink tumours in animals and some people and seems promising but it is not clear if it has any positive effects in sarcoma.
Read the detailed description
Objectives:
- - To determine the efficacy of SB939 in translocation associated sarcoma patients.
- - To determine response duration, stable disease rate and progression free survival.
- - To evaluate toxicity of SB939.
- - To investigate potential molecular factors predictive of response.
60mg SB939 will be given every other day 3 times a week for 3 weeks followed by a week off. Patients may receive a maximum of 12 cycles if they have a response to treatment in the absence of disease progression or unacceptable toxicity. Patients with stable disease may continue therapy for a maximum of 6 cycles.
- Conditions
- Metastatic Sarcoma
- Being tested
- SB939
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB939Drug
Given orally 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| SB939 | Experimental | Not described Receives: Drug: SB939 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy (as measured by objective response) of SB939 when given orally every other day 3 times a week, in patients with translocation-associated sarcomas.
The primary endpoint of this study is objective tumour response using RECIST 1.1 [Eisenhauer 2009]. Response is defined as 30% decrease in the sum of the diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response), also maintained for at least 4 weeks. The median and range of the duration of response will be assessed. A 95% confidence interval for the true objective response rate will be given.
Measured: 24 months
Secondary outcomes (3)
Response duration, stable disease rate and progression free survival in these patients.
Measured: 24 months
Tolerability and toxicity of SB939, according to NCI CTCAE 4.0, in this population
Measured: 24 months
Potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study start21 Oct 2010
- Primary completion21 Jan 2013
- Study completion16 Jan 2014
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 Metastatic SarcomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- S*BIO
- Responsible party
- Sponsor
- Investigators
- Quincy Chu, Study chair, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112384
- Sponsor's protocol ID
- I200
- Acronym
- IND200
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2010
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chu QS, Nielsen TO, Alcindor T, Gupta A, Endo M, Goytain A, Xu H, Verma S, Tozer R, Knowling M, Bramwell VB, Powers J, Seymour LK, Eisenhauer EA. A phase II study of SB939, a novel pan-histone deacetylase inhibitor, in patients with translocation-associated recurrent/metastatic sarcomas-NCIC-CTG IND 200dagger. Ann Oncol. 2015 May;26(5):973-981. doi: 10.1093/annonc/mdv033. Epub 2015 Jan 28.
PubMed 25632070
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas
- ClinicalTrials.gov ID
- NCT01112384
- Acronym / sponsor ID
- IND200 / I200
- Conditions
- Metastatic Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Collaborators
- S*BIO
- Study start
- 21 Oct 2010 (actual)
- Primary completion
- 21 Jan 2013 (actual)
- Study completion
- 16 Jan 2014 (actual)
- First posted
- 28 Apr 2010 (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 find out what effects a new drug SB939 has on you and your sarcoma.
This research is being done because there is a need for better treatment options for advanced or recurring sarcoma.
SB939 has been shown to shrink tumours in animals and some people and seems promising but it is not clear if it has any positive effects in sarcoma.
Detailed description
Objectives:
- - To determine the efficacy of SB939 in translocation associated sarcoma patients.
- - To determine response duration, stable disease rate and progression free survival.
- - To evaluate toxicity of SB939.
- - To investigate potential molecular factors predictive of response.
60mg SB939 will be given every other day 3 times a week for 3 weeks followed by a week off. Patients may receive a maximum of 12 cycles if they have a response to treatment in the absence of disease progression or unacceptable toxicity. Patients with stable disease may continue therapy for a maximum of 6 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB939 | Experimental | Drug: SB939 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with histologically diagnosed sarcomas that are associated with chromosomal translocation producing a fusion transcription factor oncogene.
- Patients must have measurable disease.
- A tissue block from primary or metastatic tumor must be available for confirmation of diagnosis, translocation subtype and correlative studies.
- Up to 1 prior chemotherapy regimen in the metastatic setting is permitted providing 28 days have elapsed.
- Prior radiation permitted provided a minimum of 28 days have elapsed.
Key exclusion criteria (11 listed)
- Cardiac exclusions; Patients with any preexisting uncontrolled cardiac condition.
- History of myocardial infarction at any time in the past.
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 5 years.
- Patients with documented CNS metastases, unless adequately treated with radiation at least 30 days prior to enrollment. Patients cannot have concurrent anti-convulsants or dexamethasone for control of symptoms. Patients with leptomeningeal disease, even with treatment, cannot be enrolled due to generally poor prognosis.
- Inability to take oral medication. Patients must be able to swallow SB939 capsules and have no gastrointestinal abnormalities (e.g. bowel obstruction or previous gastric resection) which would lead to inadequate absorption of SB939.
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 |
|---|---|---|
| SB939Given orally 3 times per week | Drug | SB939 |
Primary outcome
To determine the efficacy (as measured by objective response) of SB939 when given orally every other day 3 times a week, in patients with translocation-associated sarcomas.
Time frame: 24 months
The primary endpoint of this study is objective tumour response using RECIST 1.1 [Eisenhauer 2009]. Response is defined as 30% decrease in the sum of the diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response), also maintained for at least 4 weeks. The median and range of the duration of response will be assessed. A 95% confidence interval for the true objective response rate will be given.
3 secondary outcomes
Response duration, stable disease rate and progression free survival in these patients.
Time frame: 24 months
Tolerability and toxicity of SB939, according to NCI CTCAE 4.0, in this population
Time frame: 24 months
Potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue
Time frame: 24 months
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 4 Aug 2023.
- Results publication: PubMed 25632070Chu QS, Nielsen TO, Alcindor T, Gupta A, Endo M, Goytain A, Xu H, Verma S, Tozer R, Knowling M, Bramwell VB, Powers J, Seymour LK, Eisenhauer EA. A phase II study of SB939, a novel pan-histone deacetylase inhibitor, in patients with translocation-associated recurrent/metastatic sarcomas-NCIC-CTG IND 200dagger. Ann Oncol. 2015 May;26(5):973-981. doi: 10.1093/annonc/mdv033. Epub 2015 Jan 28.
- Individual participant dataSharing planned: No
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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.
Quincy Chu study chair
Cross Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB939 in people with Metastatic Sarcoma, run by NCIC Clinical Trials Group at 8 sites in Canada.
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 20 inclusion and 11 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. 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 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?
To determine the efficacy (as measured by objective response) of SB939 when given orally every other day 3 times a week, in patients with translocation-associated sarcomas. (time frame: 24 months). 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 NCT01112384, 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 4 Aug 2023.