A Study of APO866 for the Treatment of Cutaneous T-cell Lymphoma

NCT00431912 | Completed Phase 2

• 1 other identifier: AP3001
• Study Type: interventional
• Target: 25
• Locations: 4 countries
• Sites: 5

Brief Summary

This phase II study is designed to determine the efficacy and safety of APO866 for the treatment of patients with advanced forms of cutaneous T-cell lymphoma (CTCL). APO866 has shown to induce growth inhibition in cultures of human CTCL cells as well as in animal models with subcutaneously implanted human CTCL tumors. APO866 was considered to be safe and well-tolerated in a phase I study that treated 24 patients with advanced cancer. APO866 is administered by intravenous infusion continuously for 96 hours and that is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary efficacy endpoint will be assessed at Week 16. patients will be followed up for 12 months

Conditions

Cutaneous T-cell Lymphoma

Keywords

cutaneous T-cell lymphoma; mycosis fungoides; Sézary syndrome; APO866; phase II study

Outcome Measures

Primary Outcomes (1)

• The proportion of eligible patients with refractory or relapsed CTCL whom have a complete response or partial response on cutaneous lesions (Tumor Burden Index) and extra-cutaneous disease.

  Week 16

Secondary Outcomes (1)

• Safety and tolerability, time to response, duration of overall response, duration of stable disease and time to treatment failure.

  Week 16

Study Arms (1)

Single-arm, trinomial 2-stage design

EXPERIMENTAL

Drug: APO866

Interventions

APO866 DRUG

APO866 is administered as 0.126 mg/m²/hr for 4 consecutive days (96 hours), every 3 weeks for a total of 3 cycles

Single-arm, trinomial 2-stage design

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of CTCL including mycosis fungoides and Sézary syndrome
• Stage Ib to IVb disease (AJCC TNM staging, see Appendix B)
• Relapsed or refractory disease or intolerant to ≥ 2 prior systemic therapy. PUVA, topical nitrogen mustard, spot or total skin electron beam therapy or other radiotherapy, oral retinoids, immunotherapy (e.g. interferon-α, denileukin difitox, alemtuzumab) or mono- or poly-chemotherapy regimen will be considered systemic therapy.
• ECOG Performance Status \< 2 (see Appendix C)
• Age \> 18 years, of either sex
• Female patients with childbearing potential must be using a hormonal contraceptive, intra uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Women of childbearing potential must have a negative serum or urinary hCG pregnancy test
• Male patients, who are not surgically sterile, must use a condom with spermicide for the duration of the study
• Have given written informed consent, prior to any study related procedure not part of the patient's normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

You may not qualify if:

• Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 2 months preceding SD1
• Have had PUVA, topical nitrogen mustard, spot or total skin electron beam therapy, oral retinoids, or any, immunotherapy (e.g. interferon-α, denileukin difitox, alemtuzumab) or chemotherapy regimen within 2 weeks of SD1. Patients must have recovered from all acute toxicities.
• Evidence of CNS lymphoma
• Use of prohibited medication due to CYP3A4 metabolism of APO866, as specified in Section 6.6.2. concomitant use of these drugs will not be allowed during the study.
• Uncontrolled medical conditions, requiring surgical or pharmacological treatment (exceptions must be approved by the Study Director).
• Serious concomitant disease (e.g. significant cardiac disease) are not eligible
• Primary or acquired thrombocytopenia
• Inadequate bone marrow reserve: WBC \< 3.5x10\^9/L, neutrophils \< 1.0x10\^9/L, thrombocytes \< 100x10\^9/L, Hb \< 8.5 g/dL or coagulation abnormalities
• Inadequate liver function: total bilirubin \> 1.5 x upper limit of normal values (ULN), AST, ALT, or alkaline phosphatase \> 2.5 x ULN
• Have inadequate renal function, defined by serum creatinine \> 250 μmol/L
• Retinopathy, history of retinal laser surgery, or an ERG \< 50% of normal

Sponsors & Collaborators

• Valerio Therapeutics: lead

Study Sites (5)

Department of Dermatology, Medical University Graz

Graz, 8036, Austria

Location

Deapartment of Dermatology

Créteil, 94010, France

Location

department of Dermatologie, Hotel Dieu

Nantes, 44093, France

Location

University Clinic for Dermatology, Medical Faculty of Mannheim of the Heidelberg University

Mannheim, 68167, Germany

Location

Department of Dermatology, University Hospital of Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

N-(4-(1-benzoylpiperidin-4-yl)butyl)-3-(pyridin-3-yl)acrylamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Reinhard Dummer, MD PhD

  Department of Dermatology, University Hospital of Zürich, Gloriastrasse 31, 8091 Zürich, Switzerland

  PRINCIPAL INVESTIGATOR

• René Goedkoop, MD

  Apoxis SA, 18-20 Avenue de Sévelin, 1004 Lausanne, Switzerland

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 5, 2007
• First Posted: February 6, 2007
• Study Start: February 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

FR (2); DE (1); AU (1); CH (1)