A multi-centre, two-stage, open label phase II study to assess the efficacy and safety of APO866 in the treatment of patients with advanced melanoma.
- Conditions
- The medical condition is advanced cutaneous melanoma stage IV or unresectable stage III.MedDRA version: 8.1Level: PTClassification code 10025650Term: Malignant melanoma
- Registration Number
- EUCTR2006-000910-19-DE
- Lead Sponsor
- TopoTarget A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 43
To be eligible for inclusion into this study, the subjects must fulfil all of the following
criteria:
• Histologically confirmed diagnosis of melanoma
• Stage IV disease or stage III not amenable to surgery (AJCC, see Appendix A)
• Measurable disease, defined as at least 1 malignant lesion that could be accurately and serially measured in at least 1 dimension and for which the greatest diameter is > 10 mm as measured by spiral computed tomography (CT) scan or magnetic resonance imaging (MRI), or > 20 mm with conventional techniques. A caliper can be used for the measurement of superficial cutaneous metastases which are > 10 mm.
• Patients must be able to undergo either contrast-enhanced CT-scan or contrastenhanced MRI scan for tumor assessment
• Only one previous systemic treatment (excluding prior systemic treatment as
postoperative adjuvant therapy) is allowed and should have been terminated > 4
weeks before Study Day 1 (SD1).
• Lack of response or progression of disease after the most recent systemic therapy for advanced melanoma
• Patients must have recovered from the toxicity of any previously used treatment.
All Adverse events of previous systemic treatment must have resolved to < grade I Common Terminology Criteria for Adverse Events
• ECOG Performance Status < 1
• 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 within 7 days prior to Study Day 1
• Male patients, who are not surgically sterile, must use a condom with spermicide
for the duration of the study and 3 months thereafter
• 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
To be eligible for inclusion in this study the subjects 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 4 weeks preceding SD1
• History of brain metastases or leptomeningeal disease
• Bone-only metastatic disease
• 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.
• Use of biphosphonate drugs during the 30 days preceding the APO866 perfusion and during all the treatment period will not be allowed.
• Uncontrolled medical conditions, requiring surgical or pharmacological treatment (exceptions must be approved by the Medical Responsible of the study).
• Serious concomitant disease (e.g. significant cardiac disease)
• History of second cancer that was treated with curative intent and in complete
remission for < 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
• Primary or acquired thrombocytopenia
• Inadequate bone marrow reserve: WBC < 3.5x109/L, neutrophils < 1.0x109/L,
thrombocytes < 100x109/L, Hb < 10.0 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 > 1.5x ULN
• Retinopathy, history of retinal laser surgery, or an ERG < 50% of normal
• Pregnant of lactating female
• Abuse of alcohol or other recreational drugs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this clinical trial is to determine the anti-tumor activity of APO866 in patients with advanced cutaneous melanoma.;Secondary Objective: The secondary objectives include:<br> - the determination of the safety and tolerability of APO866 in patients with advanced cutaneous melanoma<br> - the determination of the effect of AO866 on the time to response, response duration, progression free survival, overall survival, and the evolution of VEGF during treatment.;Primary end point(s): The primary efficacy endpoint is to determine the tumor response rate as the proportion of eligible patients with stage IV cutaneous melanoma or stage III not amenable to surgery, who have an objective tumor response (complete response (CR), partial response (PR) or stable disease (SD)) to treatment with APO866.
- Secondary Outcome Measures
Name Time Method