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LeukemiaPhase 1NCT01184274

A Phase I Study of SB939 in Pediatric Patients With Refractory Solid Tumours and Leukemia

A Phase 1 study testing SB939 in people with Leukemia and Solid Tumours, run by NCIC Clinical Trials Group at 8 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research is being done because SB939 has been shown to shrink tumours in animals and in some people and seems promising, but we are not sure if it can offer better results than standard treatment. Read more about this study

Who is it for?
Ages 12 months to 18 years
Conditions the study is for
Leukemia, Solid Tumours
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
12 participants
Where
8 sitesCanada
Study dates
1 Oct 2010to 16 Jan 2014
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 12 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients in all parts of the study must have histological verification of malignancy at either original diagnosis or relapse.
  • For Part A, patients must have recurrent or refractory solid tumours, lymphoma or CNS tumours (excluding diffuse intrinsic pontine gliomas).
  • For Part B, patients must have recurrent or refractory leukemia.
  • For Part C, patients must have one of the following diagnoses: neuroblastoma, or medulloblastoma / CNS primitive neuroectodermal tumour (PNET).
  • Disease Status
  • Patients with solid tumours must have either measurable or evaluable disease (defined by a positive nuclear scan such as bone scan or metaiodobenzylguanidine (MIBG) scan. For part C only, in the case of neuroblastoma, if a lesion is isolated and /or previously irradiated and stable, a proven positive biopsy will be required to be eligible.
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  • Patients with refractory or relapsed leukemia must have greater than 25% blasts in bone marrow (M3 bone marrow); active extramedullary disease may also be present. Patients with leptomeningeal disease are not eligible.
  • Therapeutic Options:
  • The patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
  • Prior Systemic Therapy
  • Patients must have recovered from the acute effects of prior chemotherapy, immunotherapy or radiotherapy prior to study entry as follows:
  • At least 3 weeks from completion of myelosuppressive chemotherapy, biologic agents or other investigational cancer treatment
  • At least 7 days from completion of therapy with a growth factor
  • At least 6 weeks from hematopoietic stem cell rescue following myeloablative therapy
  • Post allogeneic hematopoietic transplant patients are eligible, but must have no evidence of active graft vs. host disease
  • At least 2 weeks from completion of local palliative XRT (small port)
  • At least 3 months must have elapsed if prior total body irradiation, craniospinal XRT or if ≥ 50% radiation of pelvis
  • At least 6 weeks must have elapsed if other substantial bone marrow irradiation
  • At least 6 weeks from prior MIBG therapy Age > 12 months and ≤ 18 years at the time of study entry. Performance Status: Karnofsky ≥ 60% for patients > 10 years; Lansky ≥ 50 for patients ≤ 10 years.
  • For Patients with Solid Tumours (Parts A and C):
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10 (power of 9)/L
  • Platelets ≥100 x 10(power of 9)/L
  • Hemoglobin ≥ 80 g/L
  • For Patients with Leukemia (Part B only)
  • No minimum absolute neutrophil count
  • Platelet count ≥ 20 x 10 (power of 9)/L (may receive transfusion)
  • Hemoglobin ≥ 80 g/L (may receive transfusion)
  • serum creatinine ≤ 1. 5 x upper limit of normal for age or
  • measured GFR ≥ 70 mL/min/1.73 m2
  • LVEF by ECHO or MUGA Scan within normal institutional limits
  • QTc ≤ 450 msec
  • AST and ALT ≤ 5.0 x upper limit normal for age
  • bilirubin ≤ 1.5 x upper limit normal for age
  • Additional Criteria For Part C Of The Study
  • Skin toxicity (excluding alopecia) ≤ Grade 1
  • Serum triglycerides (fasting) < 3.4 mmol/L
  • Negative urine dipstick for protein OR < 1000 mg protein/24 hour urine collection
  • No evidence of gross hematuria
  • Patient or guardian consent must be obtained on all patients according to local Institutional and/or University Human Experimentation Committee requirements.
  • Patients registered on this trial must be treated and followed at the participating centre.
  • Protocol treatment to begin within five working days of patient registration.

Who cannot join

  • Cardiac Exclusions. Patients with a pathologic cardiac arrhythmia requiring active treatment. Patients with a history of arrhythmia must be > 12 months since last treatment with no recurrence of arrhythmia in the interval.
  • Inability To Take Oral Medication. Patients must be able to take oral medication and have no gastrointestinal abnormalities (e.g. bowel obstruction or previous gastric resection) which would lead to inadequate absorption of SB939.
  • Known HIV, hepatitis B or hepatitis C infections.
  • Current treatment with agents with a known risk of Torsades de Pointes http://torsades.org (list #1).
  • Pre-existing peripheral neuropathy ≥ grade 3.
  • There is no available information regarding human fetal or teratogenic toxicities related to SB939. 13-cis-retinoic acid is known to be teratogenic. Pregnancy tests must be obtained in girls who are post menarchal. Males or females of reproductive potential may not participate unless they have agreed to an effective contraceptive method. Pregnant or breast feeding females will not be entered on this study due to the potential fetal and teratogenic adverse events.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Canada8 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7

  • Izaak Walton Killam (IWK) Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Children's and Women's Health Centre of BC Branch

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

This research is being done because SB939 has been shown to shrink tumours in animals and in some people and seems promising, but we are not sure if it can offer better results than standard treatment.

Read the detailed description

In Part A of this study, SB939 was given to children with solid tumours. The purpose of Part A of this study is to ind the highest dose of a new drug SB939 that can be giben to children without causing very severe side effects that are tolerable.

In Part B of this study, SB939 will be given to children with leukemia. The purpose of Part B, is to see whether the dose that was determined to be the best dose for patients with solid tumours is also the best dose for children with leukemia.

In Part C of this study, SB939 will be given together with 13-cis-retinoic acid. The purpose of Part C, is to see whether the SB939 dose that was determined to be the best dose in Part A is also the best dose when given in combination with 13-cis-retinoic acid.

Being tested
SB939
Medical subject headings
Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB939Drug

    Dose Levels for Part A

    -1 - 20mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing

    1. (starting dose) 25mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
    2. - 35mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
    3. - 45mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing

    4+ - Previous level + 10mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing

Study groups in NCT01184274
Study groupRoleWhat they receive
SB939ExperimentalNot described
Receives: Drug: SB939

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Maximum Tolerated Dose and RP2D in solid tumours

    Part A: patients must have recurrent or refractory solid tumours, lymphoma or CNS tumours (excluding diffuse intrinsic pontine gliomas)

    Purpose is to determine recommended phase II dose (RP2D) of oral SB939 in pediatric patients with solid tumours, with SB939 administered at a starting dose of 25 mg/m2 (70% of the adult recommended phase II dose), and given orally every other day three times / week (e.g. Monday / Wednesday /Friday OR Tuesday / Thursday / Saturday) for three consecutive weeks, followed by one week off-dosing.

    Measured: 24 months

  2. Part B: Tolerability

    Part B: patients must have recurrent or refractory leukemia

    Tolerability of the solid tumour RP2D in patients with recurrent or refractory leukemia once the RP2D has been established in solid tumours.

    Measured: 24 months

  3. Part C: Recommended Phase 2 Dose (RP2D) and Tolerability

    Part C: patients must have neuroblastoma, or medulloblastoma/CNS primitive neuroectodermal tumour (PNET)

    RP2D of oral SB939 in combination with a fixed dose of 13-cisretinoic acid in children with refractory or recurrent neuroblastoma, medulloblastoma / CNS neuroectodermal tumour (PNET), using the recommended dose determined in Part A of this study.

    Measured: 24 months

  4. Pharmacokinetics

    characterize the pharmacokinetics of SB939 in a pediatric population

    Measured: 24 months

Secondary outcomes (1)

  1. Anti-tumour activity

    antitumour activity of SB939 in pediatric tumours when given as a single agent, and when given in combination with 13-cis-retinoic acid.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2010 (estimated)
  2. Study start1 Oct 2010
  3. Primary completion12 Apr 2012
  4. Study completion16 Jan 2014

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01184274
Sponsor's protocol ID
I203
Status last verified
Apr 2020
First submitted
17 Aug 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

  • Zorzi AP, Bernstein M, Samson Y, Wall DA, Desai S, Nicksy D, Wainman N, Eisenhauer E, Baruchel S. A phase I study of histone deacetylase inhibitor, pracinostat (SB939), in pediatric patients with refractory solid tumors: IND203 a trial of the NCIC IND program/C17 pediatric phase I consortium. Pediatr Blood Cancer. 2013 Nov;60(11):1868-74. doi: 10.1002/pbc.24694. Epub 2013 Jul 25.

    PubMed 23893953

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB939 in people with Leukemia and Solid Tumours, 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 41 inclusion and 6 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 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?

Part A: Maximum Tolerated Dose and RP2D in solid tumours (time frame: 24 months). The study lists 4 primary outcomes in all. 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 NCT01184274, 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.

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