NCT01442662

Brief Summary

The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2019

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

6.5 years

First QC Date

August 10, 2011

Last Update Submit

January 29, 2020

Conditions

Leiomyosarcoma

Keywords

Metastatic or relapsed uterine or soft tissue leiomyosarcoma

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    To assess the 9-month Progression Free Survival in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas and treated with Gemcitabine and Pazopanib

    9 months

Secondary Outcomes (3)

  • disease control rate and overall response rate

    12 weeks

  • Safety of the combination Gemcitabine-Pazopanib

    during the entire trial

  • metabolic response by using PET scan

    6 weeks

Study Arms (1)

pazopanib, gemcitabine

EXPERIMENTAL

pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle

Drug: pazopanib + gemcitabine

Interventions

pazopanib + gemcitabineDRUG

pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle

pazopanib, gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre G.F Leclerc

Dijon, 21034, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

CHU Timone

Marseille, 13385, France

Location

Centre Val d'Aurelle Paul Lamarque

Montpellier, 34298, France

Location

Institut de Cancérologie de l'Ouest/Centre René Gauducheau

Nantes Saint Herblain, 44806, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie - Hôpital Claudius Regaud

Paris, 75005, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Curie - Hopital René Huguenin

Saint-Cloud, 92210, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

  • Pautier P, Penel N, Ray-Coquard I, Italiano A, Bompas E, Delcambre C, Bay JO, Bertucci F, Delaye J, Chevreau C, Cupissol D, Bozec L, Eymard JC, Saada E, Isambert N, Guillemet C, Rios M, Piperno-Neumann S, Chenuc G, Duffaud F. A phase II of gemcitabine combined with pazopanib followed by pazopanib maintenance, as second-line treatment in patients with advanced leiomyosarcomas: A unicancer French Sarcoma Group study (LMS03 study). Eur J Cancer. 2020 Jan;125:31-37. doi: 10.1016/j.ejca.2019.10.028. Epub 2019 Dec 10.

    PMID: 31835236DERIVED

MeSH Terms

Conditions

LeiomyosarcomaNeoplasm Metastasis

Interventions

pazopanibGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Patricia Pautier, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

September 28, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2018

Study Completion

May 28, 2019

Last Updated

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

PD will not be shared at an individual level, they will be part of the study database including all enrolled patients

Locations

FR(17)