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

NCT01112384 | Completed Phase 2 DMC

• 1 other identifier: I200
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

Metastatic Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (3)

• Response duration, stable disease rate and progression free survival in these patients.

  24 months

• Tolerability and toxicity of SB939, according to NCI CTCAE 4.0, in this population

  24 months

• Potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue

  24 months

Study Arms (1)

SB939

EXPERIMENTAL

Drug: SB939

Interventions

SB939 DRUG

Given orally 3 times per week

SB939

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• S*BIO: collaborator

Study Sites (8)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

Related Publications (1)

• 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.

  PMID: 25632070 RESULT

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Quincy Chu

  Cross Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 28, 2010
• Study Start: October 21, 2010
• Primary Completion: January 21, 2013
• Study Completion: January 16, 2014
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)