Hodgkin's LymphomaPhase 2SAPHIRENCT01037478
Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma
A Phase 2 study testing Resminostat (4SC-201) in people with Hodgkin's Lymphoma, run by 4SC AG at 10 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Resminostat (4SC-201)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Dec 2009to Mar 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Patients must have histological or cytological evidence of Hodgkin's Lymphoma (all subtypes are acceptable)
- Patients must have relapsed or refractory Hodgkin's Lymphoma (HL) defined as relapse following initial therapy or lack of response to first line therapy and treatment with second-line (salvage therapy). Patients may have also undergone high-dose chemotherapy with autologous stem cell transplantation at least 12 weeks prior to study entry
- Patients must have measurable anatomical disease present on CT scan
- Patients must have an ECOG Performance Score of 0, 1 or 2
Main Exclusion Criteria:
- Patients who have received previous treatment with an HDAC inhibitor
- Patients who have undergone allogeneic hematopoietic stem cell transplantation
- Patients with known or suspected involvement of the CNS by HL
- Patients treated with agents known to prolong the QT interval or with a confirmed QTcF > 450 msec
- Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current PSA < 0.1 ng/ml; or cervical intraepithelial neoplasia
- Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness that could preclude their participation in the trial, pose an undue medical hazard or interfere with the interpretation of the trial results, including, but not limited to, patients with congestive heart failure (NYHA Class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring > 2 medications for adequate control; diabetes mellitus with > 2 episodes of ketoacidosis in the preceding 12 months
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Poland5 sites
Uniwersyteckie Centrum Kliniczne
Gdansk
Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu
Poznan
Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii
Warsaw
Wojskowy Instytut Medyczny
Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu
Wroclaw
Czechia3 sites
Fakultní nemocnice Brno
Brno
Fakultní nemocnice Hradec Kralové
Hradec Kralové
Fakultní nemocnice Kralovske Vinohrady
Prague
Romania2 sites
Institutul Clinic Fundeni
Bucharest
Spitalul Clinic Coltea
Bucharest
About this study
Official title: A Phase 2 Proof of Concept Study to Evaluate the Efficacy, Safety and Pharmacokinetics of the HDAC Inhibitor 4SC-201 in Patients With Relapsed or Refractory Hodgkin's Lymphoma
The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Resminostat (4SC-201)
- Keywords
- Hodgkin's Lymphoma, HDAC, 4SC-201, Resminostat, Phase II
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resminostat (4SC-201)Drug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Resminostat (4SC-201) | Experimental | oral administration Receives: Drug: Resminostat (4SC-201) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma.
Measured: 12 weeks
Secondary outcomes (6)
Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)
Measured: 12 weeks
Assessment of the overall survival (OS)
Measured: 12 weeks
Determination of progression free survival (PFS), including radiological and symptomatic progression
Measured: 12 weeks
Determination of time to progression (TTP), including objective and symptomatic progression
Measured: 12 weeks
Determination of duration of response (DOR)
Measured: 12 weeks
Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomaStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4SC AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan Walewski, Prof., Principal investigator, Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037478
- Sponsor's protocol ID
- 4SC-201-2-2009
- Acronym
- SAPHIRE
- Status last verified
- Jan 2014
- First submitted
- 22 Dec 2009
- Last updated
- 16 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Proof of Concept Study to Evaluate the Efficacy, Safety and Pharmacokinetics of the HDAC Inhibitor 4SC-201 in Patients With Relapsed or Refractory Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT01037478
- Acronym / sponsor ID
- SAPHIRE / 4SC-201-2-2009
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Hodgkin's Lymphoma, HDAC, 4SC-201, Resminostat, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- 4SC AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Dec 2009 (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 determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resminostat (4SC-201) | Experimental | Drug: Resminostat (4SC-201)oral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Resminostat (4SC-201)oral administration | Drug | Resminostat (4SC-201) |
Primary outcome
Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma.
Time frame: 12 weeks
6 secondary outcomes
Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)
Time frame: 12 weeks
Assessment of the overall survival (OS)
Time frame: 12 weeks
Determination of progression free survival (PFS), including radiological and symptomatic progression
Time frame: 12 weeks
Determination of time to progression (TTP), including objective and symptomatic progression
Time frame: 12 weeks
Determination of duration of response (DOR)
Time frame: 12 weeks
Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing
Time frame: 12 weeks
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 16 Jan 2014.
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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.
Jan Walewski, Prof. principal investigator
Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resminostat (4SC-201) in people with Hodgkin's Lymphoma, run by 4SC AG at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland, Czechia, Romania. 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?
Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2014.