Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01442662 : Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Histologically confirmed diagnosis of metastatic or relapsed of uterine or soft
tissue leiomyosarcoma previously treated with one line of chemotherapy with at least
an anthracycline. Patients who have received adjuvant therapy less than one year
before relapse were considered to have received a first line therapy for metastatic
disease)

- Delay between the end of previous treatment (chemotherapy, hormonotherapy,
radiotherapy, immunotherapy, surgery or tumor embolisation) must be > 4 weeks

- At least one measurable lesion with RECIST criteria with progressive disease between
the last 6 weeks between inclusion. One target at least must be in a non irradiated
area

- performance status ECOG ? 2

- Age ? 18 years

- Subjects must provide written informed consent prior to performance of study-specific
procedures, and must be willing to comply with treatment and follow up

- Adequate hematologic function

- Adequate coagulation function

- Adequate renal function

- Adequate liver function

- Patients must be affiliated to a Social Health Insurance

- Women of childbearing potential must be using a medically accepted method of
contraception and must have a negative serum pregnancy test within 14 days of
enrollment and/or urine pregnancy test 72 hours prior to the administration of the
first study treatment.

- LVEF ? site limits

Main Exclusion Criteria:

- Other uterine or soft tissue sarcomas

- Symptomatic or known brain metastasis

- Radiation therapy on the only evaluable lesion

- Anti coagulant treatment

- strong inhibitors or inducers of the isoenzyme CYP3A4 treatment

- Known sero-positivity (HIV, HbC, HbS)or uncontrolled infection

- other prior malignancy except basal cell skin cancer or carcinoma in situ of the
cervix

- Clinically significant gastrointestinal abnormalities that may affect the absorption
of the IP

- Corrected QT interval > 480 msec

- Other serious underlying pathology that would preclude study treatment

- Calcium and magnesium levels inferior to standard levels (measured within 14 days
before the first pazopanib dose) and potassium levels inferior to standard levels
(measured within 72 hours before the first pazopanib dose)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01442662      |      Link to official Clinicaltrials.gov listing
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