A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03344536|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Fulvestrant Drug: Debio 1347||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open-label, single institution, phase Ib/phase II non-randomized trial.|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of Debio 1347 Plus Fulvestrant in Patients With FGFR-Amplified Endocrine Receptor Positive Metastatic Breast Cancer|
|Actual Study Start Date :||November 10, 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: fulvestrant and Debio 1347
Fulvestrant will be administered according to its approved dose of 500 mg intramuscularly on days 1, 15, 29 and then every 28 days (+/-3 days) thereafter. Debio 1347 will be administered orally daily (1 cycle is 28 days) and the dose of Debio 1347 could be deescalated. The dosage in the phase 2 portion will be the MTD/RP2D determined in the phase 1b portion.
Fulvestrant will be administered according to its approved dose of 500 mg intramuscularly on days 1, 15, 29 and then every 28 days (+/-3 days) thereafter.
Drug: Debio 1347
Debio 1347 will be administered orally daily (1 cycle is 28 days) and the dose of Debio 1347 could be deescalated.
- Number of patients experiencing Dose Limiting Toxicity (Phase I) [ Time Frame: 1 year ]Selected non-hematologic and hematologic toxicities, as measured by the NCI CTCAE Version 4.0, will be described by frequency and grade, by cycle and over all cycles, with the maximum grade over all cycles used as the summary measure per patient.
- proportion of patients who have a best overall response (Phase II) [ Time Frame: 1 year ]Tumor response is based on the RECIST v.1.1.
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): NCT03344536
|Contact: Komal Jhaveri, MD FACPfirstname.lastname@example.org|
|Contact: Maura Dickler, MD||646-888-4560|
|United States, New York|
|Memorioal Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Komal Jhaveri, MD FACP 646-888-5145|
|Contact: Maura Dickler, MD 646-888-4560|
|Principal Investigator: Komal Jhaveri, MD FACP|
|Principal Investigator:||Komal Jhaveri, MD FACP||Memorial Sloan Kettering Cancer Center|