Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT01193595
Eligibility Criteria:
Inclusion criteria:
* Histologically or cytologically proven solid malignant tumor at the first diagnosis with the exception of squamous non small cell lung cancer (NSCLC).
* Advanced neoplastic disease (i.e. metastatic or locally unresectable advanced disease)
* Presence of one measurable lesion at baseline in the MTD expanded cohort
Exclusion criteria:
* ECOG (Eastern cooperativeOncology Group) performance status \> 1
* Concurrent treatment with any other anticancer therapy
* Pericardial effusion requiring intervention (drainage)
* History of brain metastasis, spinal cord compression or carcinomatous meningitis or new evidence of brain metastasis on screening Computed tomography (CT) or Magnetic resonance imaging (MRI) scan
* Diagnosis of squamous Non Squamous Cell Lung Cancer (NSCLC) or with mixed cell type with predominant squamocellular histology
* Hormone sensitive prostate cancer
* Abdominal Radiotherapy
* Major surgery within the last month of study enrollment or surgical wound not fully healed before study enrollment
* High cumulative doses of anthracycline
* Inadequate organ function
* Inadequate hematology function or poor bone marrow reserve
* Any of the following within 6 months prior to study enrollment: peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease and diverticulitis
* Any history or underlying cardiac condition that may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01193595
Study Brief:
Protocol Section:
NCT01193595