A multicenter open label phase II study to assess the efficacy and safety of APO866 in the treatment of patients with refractory or relapsed cutaneous T-cell lymphoma - APO866 for CTCL

• Register: EUCTR
• Last refreshed on: 22 October 2012
• Main ID: EUCTR2005-006157-24-DE
• Date of registration: 07/06/2006
• Prospective Registration: Yes
• Primary sponsor: TopoTarget A/S
• Public title: A multicenter open label phase II study to assess the efficacy and safety of APO866 in the treatment of patients with refractory or relapsed cutaneous T-cell lymphoma - APO866 for CTCL
• Scientific title: A multicenter open label phase II study to assess the efficacy and safety of APO866 in the treatment of patients with refractory or relapsed cutaneous T-cell lymphoma - APO866 for CTCL
• Date of first enrolment: 31/01/2007
• Target sample size: 25
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-006157-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
To be eligible for inclusion into this study, the patients must fulfil all of the following criteria:
Histologically confirmed diagnosis of CTCL including mycosis fungoides and Sézary syndrome or others according the WHO/EORTC classification18
Stage Ib to IVb disease (AJCC TNM staging)
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-a, denileukin difitox, alemtuzumab) or mono- or poly-chemotherapy regimen will be considered systemic therapy.
ECOG performance status < 2
Age > 18 years, of either sex.
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any study related procedure not part of the patient’s normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
To be eligible for inclusion in this study the patients must not meet any of the following criteria:
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-a, denileukin difitox, alemtuzumab) or chemotherapy regimen within 2 weeks of SD1. Patients must have recovered of all acute toxicities.
Evidence of CNS lymphoma
Use of concomitant prohibited medication due to CYP3A4 metabolism of APO866
Use of bisphosphonate drugs during the 30 days preceding the APO866 perfusion
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 < 3.5x109/L, neutrophils < 1.0x109/L, thrombocytes < 100x109/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 mmol/L
Retinopathy, history of retinal laser surgery, or in the case of abnormal result on either of the corrected visual acuity color vision, threshold visual field, Amsler grid and fundus oculi tests, an ERG < 50% of normal
Pregnant or breastfeeding. Female patients with child-bearing 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. Females whom are surgically sterile or post-menopausal are eligible for the study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Primary cutaneous lymphomas are non-Hodgkin lymphomas that present to the skin without evidence of extracutaneous disease at the time of diagnosis. It refers to either to cutaneous T-cell lymphoma (CTCL) or cutaneous B-cell lymphoma (CBCL). The primary cutaneous lymphomas are classified according to the WHO-EORTC classification. CTCL constitutes about 65% of all primary cutaneous lymphomas, of which mycosis fungoides is the most prevalent clinical presentation.
MedDRA version: 8.1 Level: PT Classification code 10028483

Intervention(s)

Product Name: N-[4-(benzoylpiperidin-4-yl)butyl]-3-(pyridin-3-yl) acrylamide
Product Code: APO866
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 201034-75-5
Current Sponsor code: APO866
Other descriptive name: FK866, FR228866, K22.175
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: To determine the anti-tumor activity of APO886 in patients with relapsed or refractory CTCL

Secondary Objective: To determine the safety and tolerability of APO866 in this population
To determine the effect of APO866 on the time to response, response duration and time to treatment failure.

Primary end point(s): To determine the anti-tumor activity of APO866 in patients with relapsed or refractory CTCL

Secondary ID(s)

Not available

AP3001