Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
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|ClinicalTrials.gov Identifier: NCT01251354|
Recruitment Status : Terminated (The futility analysis of study NCT00910091 in patients with endometrial cancer shows that the primary endpoint will not be reached.)
First Posted : December 1, 2010
Results First Posted : September 2, 2015
Last Update Posted : October 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: BN83495||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, International, Multicenter, Open-label, Proof of Concept Study of BN83495 in Postmenopausal Women With Advanced, Metastatic or Recurrent Oestrogen Receptor (ER) Positive Endometrial Carcinoma Who Have Received One Line of Chemotherapy in the Adjuvant or Metastatic Setting.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||July 2011|
1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
- Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1) [ Time Frame: 12 weeks ]
CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study.
PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- Number of Participants With Adverse Events [ Time Frame: Up to 28 days after last dose ]
- Determination of Time to Progression (TTP) in This Patient Population [ Time Frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died ]Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.
- Determination of Progression Free Survival (PFS) in This Patient Population [ Time Frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died ]Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.
- Determination of Overall Response Rate (ORR) in This Patient Population [ Time Frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died ]Overall Response Rate (ORR): Defined as the sum of CR and PR.
- Determination of Duration of Response in This Patient Population [ Time Frame: After the last enrolled patient has been followed for at least 6 months or has progressed or died ]Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.
- Determination of Overall Survival in This Patient Population [ Time Frame: 2 years after the last patient enrolled ]Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251354
|United States, Georgia|
|Dept of Obstetrics and Gynecology, Medical College of Georgia|
|Augusta, Georgia, United States, 30912|
|United States, Minnesota|
|Division of Gynecologic Oncology, University of Minnesota Medical Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Pennsylvania|
|Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Crozer Chester medical Center|
|Upland, Pennsylvania, United States, 19103|
|London Health Sciences Centre, University of Western Ontario|
|London, Ontario, Canada, N6A 4L6|
|Department of Oncology, Ottawa Cancer Center|
|Ottawa, Ontario, Canada, K1H 8L6|
|Dept of Obstetrics and Gynecology, Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique|
|Montreal, Quebec, Canada, H2L 4M1|
|Department of Oncology, McGill University|
|Montreal, Quebec, Canada, H2W 1S6|
|Study Director:||Anne Kornowski, MD||Ipsen|