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:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01979393
Eligibility Criteria:
Inclusion Criteria:
* Patients who are suitable for treatment with doxorubicin +/- ifosfamide and fall within one of the following patient populations:
• HGUS, HGESS, HGLMS and HG adenosarcoma
* FIGO stage II and stage III : if adjuvant chemotherapy is proposed
* FIGO stage IV: if first line chemotherapy is proposed
* Metastatic: diagnosed with disease relapse after local treatment for primary tumor
* at least 18 years old
* written informed consent
* Central pathological confirmation: Histological evidence of HGUS, HGESS, HGLMS and HG adenosarcoma
* Non-progressive patients (CR, PR, SD) at the end of the first line treatment (standard chemotherapy consisting of 4 to 6 cycles of anthracyclines alone or in combination with ifosfamide)
* WHO/ECOG performance status 0-2
* Adequate organ and bone marrow function within 3 days prior to the first dose of study treatment (Cabozantinib/placebo)
* Clinically normal cardiac function
* Women of child bearing potential must have a negative serum/urine pregnancy test within 3 days prior to the first dose of study treatment
* Adequate birth control measures
Exclusion Criteria:
* low-grade ESS, leiomyosarcoma (low or intermediate), carcinosarcoma, low-grade adenosarcoma, rhabdomyosarcoma (alveolar or embryonal) and soft tissue PNET of uterus/cervix.
* contraindications to cabozantinib
* not able to swallow and retain oral tablets
* planned use of chemotherapy, radiation therapy, radionuclide treatment, small molecule tyrosine kinase inhibitor or hormonal therapy, and any other investigational agent (Cabozantinib/placebo) during the treatment period
* concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
* patient with poorly controlled hypertension defined at baseline as blood pressure \>150/90
* patients who have suffered a cerebrovascular accident at any time in the past, patients who have suffered a transient ischemic attack in the past 6 months, patients who have suffered a deep venous thrombosis (DVT) or a pulmonary embolism in the past 6 months
* Gastrointestinal disorders
* patients with radiographic evidence of cavitating pulmonary lesion(s)
* patients with tumor in contact with, invading or encasing any major blood vessels
* patients evidence of tumor invading the GI tract
* evidence of active bleeding or bleeding diathesis
* hemoptysis ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment
* signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
* clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment
* prior major surgery or trauma within 6 weeks prior to first dose of study drug and any wound, fracture, or ulcer should be completely healed
* concurrent or planned treatment with strong inhibitors or inducers of cytochrome P450 3A4/5
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01979393
Study Brief:
Protocol Section:
NCT01979393