E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Platinum-Resistant Epithelial Ovarian Cancer with KRAS Wild-type |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033128 |
E.1.2 | Term | Ovarian cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate response rate in platinum-resistant, ovarian cancer patients without KRAS mutations (KRAS wild-type) treated with pegylated liposomal doxorubicin supplemented by biological treatment with panitumumab.
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E.2.2 | Secondary objectives of the trial |
To investigate the PFS and OS in ovarian cancer patients treated with pegylated liposomal doxorubicin and panitumumab. Furthermore, to investigate the clinical safety and toxicity of the treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histological confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer stage I-IV.
• A: First line treatment with first line chemotherapy with a platinum-based regimen with either progression or no response during 1.line chemotherapy, or relapse within 6 months after end of 1. line chemotherapy.
OR
B: Patients receiving second line with a platinum-based regimen with either progression or no response during second line chemotherapy, or relapse within 6 months after end of second line chemotherapy.
• Maximum two prior lines of chemotherapy (both platinum-based).
• Age ≥ 18 years.
• Performance status 0-2.
• Measurable disease by CA125 GCIG criteria’s (evaluation of response according to CA 125 is used in this protocol).
• KRAS wild type.
• Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment): WBC ≥ 3.0 x 109/l or neutrophils (ANC) ≥ 1.5 x 109/l Platelet count ≥ 100 x 109/l Hemoglobin ≥ 9.7 g/dl (6 mmol/L) Serum bilirubin ≤ 1.5 x UNL Serum transaminases ≤ 2.5 x UNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases Serum creatinine ≤ 1.5 x UNL Magnesium ≥ lower limit of normal Calcium ≥ lower limit of normal
• Written informed consent
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E.4 | Principal exclusion criteria |
• Prior treatment with chemotherapy or biological targeted treatment except 1. or 2. line chemotherapy with platinum or combination platinum/taxane (bevacizumab allowed as part of the 1. line treatment).
• Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial.
• Pregnant or breast-feeding or planning to become pregnant within 6 months after end of treatment. For fertile women a negative pregnancy test at screening is mandatory.
• Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months following treatment.
• Other present or previous malignancy except curatively treated cervical cancer, non-melanotic skin cancer or other cancer with minimal risk of relapse.
• CNS metastasis.
• History of any chronic medical or psychiatric condition or laboratory abnormality that are not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration (e.g. diabetes, cardiac diseases, hypertension).
•Clinically significant cardiovascular disease ≤ 1 year before enrollment/randomization, including: -Myocardial infarction or unstable angina within 6 months of randomization. -New York Heart Association (NYHA) ≥ Grade 2 congestive heart failure. Even if medically controlled. -Poorly controlled cardiac arrhythmia despite medication (patients with rate- controlled atrial fibrillation are eligible).
• Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed).
• Allergy to the ingredients of the study medication or to Staphylococcus Protein A.
• History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
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E.5 End points |
E.5.1 | Primary end point(s) |
Response rates (based on GCIG modified CA-125 criteria’s (30;31)) RECIST criteria will not be used in this protocol.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |