Evaluation of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6 (ABORL)
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|ClinicalTrials.gov Identifier: NCT03356223|
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : February 5, 2020
This trial is an open-label, single arm, Phase II study using an A'Hern single stage design.
The molecular prescreening step will allow to defined HPV tumor status as well as molecular status CDKN2A, CCND1 and CDK6. Following this centralized molecular screening, only patients with HPV negative status and with tumor harboring CDKN2A homozygous deletion and/or CCND1 amplification and/or CDK6 amplification could initiate abemaciclib at time of documented radiological progression. Patients will be treated with ABEMACICLIB, 400 mg/day with 2 doses of 200 mg 12 hour apart (QH12). A cycle is defined as an interval of 28 days. For each 28-day cycle, a total of 56 doses of study drug will be dispensed.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Advanced Cancer Metastatic Cancer||Drug: Abemaciclib||Phase 2|
SAMPLE SIZE DETERMINATION The primary endpoint is the non-progression rate (CR, PR, SD as per RECIST 1.1) after 8 weeks of treatment.
The sample size calculation was based on an A'Hern single stage phase II design, with a minimum success (non- progression) rate considered of interest of p1=40% and an uninteresting rate of p0=15%. Assuming a type I error alpha of 0.05 and 85% power, 23 patients are needed to reject the null hypothesis H0: p<=p0 vs the alternative hypothesis H1: p ≥ p1 in a unilateral situation.
Based on the assumption that 10% of the patients may be non-evaluable, 25 patients will be included in the study.
DATA ENTRY AND DATA MANAGEMENT All the data concerning the patients will be recorded in the eCRF throughout the study. SAE reporting will be paper-based by Fax.
The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol, Good Clinical Practices (GCP) and local low requirements.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Aiming to Evaluate the Clinical Interest of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6|
|Actual Study Start Date :||February 5, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||September 2021|
400mg/day with 2 doses of 200mg 12-hour apart For each 28-day cycle, a total of 56 doses of study drug will be dispensed.
Route of administration : oral
Duration of treatment until the patient experiences an unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
- The 8-week non-progression rate defined as the rate of patients with complete response (CR), partial response (PR) or stable disease (SD) lasting at least 8 weeks, according to RECIST v1.1 [ Time Frame: 8 weeks after start of treatment ]
- 8-week Objective response rate [ Time Frame: 8 weeks after start of treatment ]Objective response rate after 8 weeks is defined as the proportion of patients with complete or partial response after 8 weeks of treatment according to RECIST 1.1.
- Duration of response [ Time Frame: 12 months after start of treatment ]The Duration of Response (DoR) will be measured from the time of first documented response (CR or PR as per RECIST 1.1) until the first documented disease progression or death due to underlying cancer, or censored at the date of the last available tumor assessment
- Best response rate [ Time Frame: 12 months after start of treatment ]
- Time to progression [ Time Frame: 12 months after start of treatment ]The Time to Progression will be measured from the time of treatment start until the first documented disease progression
- Time to Treatment failure [ Time Frame: 12 months after start of treatment ]The Time to treatment failure will be measured from the time of treatment start until discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death
- Progression Free survival [ Time Frame: 12 months after start of treatment ]Progression-Free Survival (PFS) will be measured from the date of inclusion until the date of event defined as the first documented progression or death from any cause. Patients with no event at the time of the analysis will be censored at the date of the last available tumor assessment. PFS will be estimated using the Kaplan-Meier method
- Overall Survival [ Time Frame: 12 months after start of treatment ]Overall survival will be measured from the date of treatment start to the date of death from 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): NCT03356223
|Contact: Jérôme FAYETTE, MD||04 78 78 51 firstname.lastname@example.org|
|Bordeaux, France, 33075|
|Contact: Amaury DASTE, MD 05 56 79 58 08 email@example.com|
|Principal Investigator: Amaury DASTE, MD|
|Sub-Investigator: Charlotte BONNET, MD|
|Sub-Investigator: Valérie COCHIN, MD|
|Sub-Investigator: Laurence DIGUE, MD|
|Sub-Investigator: Julie LALLIER, MD|
|Sub-Investigator: Amandine QUIVY, MD|
|Sub-Investigator: Alain RAVAUD, PH|
|Centre Léon Bérard||Recruiting|
|Lyon, France, 69373|
|Contact: Jérôme FAYETTE, MD 04 78 78 51 03 firstname.lastname@example.org|
|Sub-Investigator: Eve-Marie NEIDHARDT, MD|
|Sub-Investigator: Philippe TOUSSAINT, MD|
|Principal Investigator: Jérôme FAYETTE, MD|
|Centre Antoine Lassagne||Recruiting|
|Nice, France, 06189|
|Contact: Esma SAADA-BOUZID 04 92 03 15 14 email@example.com|
|Principal Investigator: Esma SAADA-BOUZID, MD|
|Principal Investigator:||Jérôme FAYETTE, MD||Centre Leon Berard|