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A Phase II Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas

Phase 2
16 Years
Open (Enrolling)
Metastatic Sarcoma

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Trial Information

A Phase II Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas


1. - To determine the efficacy of SB939 in translocation associated sarcoma patients.

2. - To determine response duration, stable disease rate and progression free survival.

3. - To evaluate toxicity of SB939.

4. - To investigate potential molecular factors predictive of response.

50mg 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.

Inclusion Criteria:

- 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.

- 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

Exclusion Criteria:

- 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.

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Description:

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.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Quincy Chu

Investigator Role:

Study Chair

Investigator Affiliation:

Cross Cancer Institute


Canada: Health Canada

Study ID:




Start Date:

March 2010

Completion Date:

November 2012

Related Keywords:

  • Metastatic Sarcoma
  • Sarcoma