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Completed

NCT Number: NCT01037478

Resminostat (4SC-201) in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fakultní nemocnice Brno, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resminostat (4SC-201)

Drug

oral administration

Primary outcomes

  1. 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

Secondary outcomes

  1. Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)

    Time frame: 12 weeks

  2. Assessment of the overall survival (OS)

    Time frame: 12 weeks

  3. Determination of progression free survival (PFS), including radiological and symptomatic progression

    Time frame: 12 weeks

  4. Determination of time to progression (TTP), including objective and symptomatic progression

    Time frame: 12 weeks

  5. Determination of duration of response (DOR)

    Time frame: 12 weeks

  6. Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

4SC AG

Industry

Registry information

Official study 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

Acronym: SAPHIRE

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Dec 23, 2009
Registry last updated
Jan 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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