| Titre |
A Phase I/II Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Fulvestrant in Subjects With ER+ Breast Cancer |
| Protocole ID |
GSK201973 |
| ClinicalTrials.gov ID |
NCT02964507 |
| Type(s) de cancer |
Sein |
| Phase |
Phase I-II |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Traitement |
| Médicament |
GSK525762 et Fulvestrant |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DU SAINT-SACREMENT
1050 Ch Ste-Foy, Québec, QC, G1S 4L8
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dre Louise Provencher
|
| Coordonnateur(trice) |
Guylaine Julien
418-682-7511 poste 7384
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Females 18 years old and greater with histologically or cytologically confirmed diagnosis of advanced or metastatic adenocarcinoma of the breast.
-
History of prior therapy that satisfies one of the following criteria:
- Disease that progressed during treatment or within 12 months of completion of adjuvant therapy with tamoxifen and/or an aromatase inhibitor (AI).
- Disease that progressed during treatment or within 1 month after the end of treatment with prior tamoxifen, AI, or cyclin-dependent kinase (CDK) 4/6 inhibitor plus letrozole, for advanced/metastatic disease.
- Documentation of ER-positive and/or progesterone receptor (PR)-positive tumor.
- Documentation of human epidermal growth factor receptor 2 (HER2)-negative tumor.
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST)
- Adequate organ function as per pre-defined hematologic, hepatic, renal, and cardiac criteria.
|
| Critètes d'exclusion |
- Prior therapy with more than one line of cytotoxic chemotherapy following diagnosis of advanced/metastatic disease, or disease which has progressed despite prior fulvestrant therapy.
- Concomitant active malignancy other than ER+ breast cancer.
- Therapeutic-dose anticoagulation must be discontinued and coagulation parameters must be normalized prior to the first dose of GSK525762 and fulvestrant.
- Evidence of severe or uncontrolled systemic diseases (example, unstable or uncompensated respiratory, hepatic, renal, cardiac disease, or clinically significant bleeding episodes).
- Subjects with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term including subjects with massive uncontrolled effusions, pulmonary lymphangitis, and over 50% of liver involvement in metastases.
- Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression.
- Cardiac abnormalities
|
Groupe d'étude en oncologie du Québec