Nintedanib+Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Safety and Pharmacodynamics
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|ClinicalTrials.gov Identifier: NCT02619162|
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Nintedanib Drug: Letrozole||Phase 1|
Phase 0 / I:
At level 1 it includes three patients. If any patient suffers dose limiting toxicity (DLT), it proceeds to the increase in dose to the next level. If 2/3 patients experience DLT, he will close the increased dose and extended / investigate the previous dose level with 3 additional patients.
If the level 2, but less than 1/3 the minimum of 6 patients experience TLD is reached, the phase I be suspended because not expected another rise above Level 2.
- Level 1: Nintedanib 150 mg twice daily + oral letrozole 2.5 mg / day orally, in a cycle of 28 days.
- Level 2: Nintedanib 200 mg twice daily via oral + letrozole 2.5 mg / day orally, in a cycle of 28 days.
- At least the first cycle will be administered during Phase I. A total of six four-week cycles were administered at the discretion of the investigator.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nintedanib Plus Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Phase 0/1 Safety and Pharmacodynamics|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||June 2018|
Tablets of 100 mg. or 150 mg.
Other Name: BIFF 1120
Tablet of 2.5 mg.
- Dose limiting toxicity [ Time Frame: 1-6 months ]Classified according to the version 4.03 of CTCAE criteria NCI1
- Evaluating FGFR1 modulation and inhibition levels of 17-B Estradiol [ Time Frame: 1-6 months ]Assess the pharmacodynamic modulation of FGFR1 and inhibition levels of 17-B: determine plasma levels of FGF 23 ang 17- B estradiol (pg/mL)
- Pharmacokinetic interactions [ Time Frame: 29 days ]Determine the pharmacokinetic interactions nintedanib combined with letrozole: determine plasma levels of Nintedanib and Letrozole at day 0, day 15 and day 29 (Cmax)
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): NCT02619162
|Hospital Universitario de Fuenlabrada|
|Fuenlabrada, Madrid, Spain, 28942|
|Hospital de La Princesa|
|Madrid, Spain, 28006|
|Madrid, Spain, 28223|
|Study Chair:||Marta Cardona||Fundacion CRIS de Investigación para Vencer el Cáncer|