A Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas (IND200)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01112384
First received: April 14, 2010
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Sarcoma
Drug: SB939
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of SB939 in Patients With Translocation-Associated Recurrent/Metastatic Sarcomas

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Response duration, stable disease rate and progression free survival in these patients. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Tolerability and toxicity of SB939, according to NCI CTCAE 4.0, in this population [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2010
Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB939 Drug: SB939
Given orally 3 times per week

Detailed Description:

Objectives:

  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.

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112384

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University - Dept. Oncology
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Quincy Chu Cross Cancer Institute
  More Information

No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01112384     History of Changes
Other Study ID Numbers: I200
Study First Received: April 14, 2010
Last Updated: January 16, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014