To hear about similar clinical trials, please enter your email below
Trial Title:
Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma
NCT ID:
NCT05519917
Condition:
Chordoma of Clivus
Conditions: Official terms:
Chordoma
Afatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Afatinib
Description:
Subjects will receive evaluations at the beginning of treatment, after every three cycles
and at the end of the whole study.
Arm group label:
Afatinib
Summary:
This is a single arm, open label, single center, and prospective, interventional study to
explore clinical efficacy of afatinib in patients with chordoma of skull base. Subject
meeting the inclusion criteria will take afatinib (40 mg daily) orally, 4 weeks for a
cycle. The primary objective is to assess the efficacy of afatinib in chordoma of skull
base by objective response rate (ORR). The Secondary objectives is to assess progression
free survival (PFS), overall survival (OS), tumor response duration and tumor shrinkage
degree in patients with chordoma of skull base after using afatinib; to evaluate the
safety and tolerability of afatinib in patients with chordoma of skull base.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients of 18 years and above;
- Patients with pathologically proven EGFR and/or HER2 expressing relapsed or residual
chordoma of skull base, inappropriate or unwilling to receive surgery or
radiotherapy;
- Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x
109/L, platelets ≥ 75 x 109/L);
- An adequate renal function with GFR ≥ 45 ml/min calculated by Cockroft-Gault
formula;
- Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≤ 3 times ULN;
- Ability to swallow medication;
- Able to understand and provide written informed consent prior to any study
procedures.
Exclusion Criteria:
- Life expectancy of less than 3 months;
- Known hypersensitivity to afatinib;
- Major surgery less than 4 weeks prior to start of the study;
- Patients who once participated in other clinical trials within 14 days before the
initiation of the study;
- Systemic anti-cancer therapy within 28 days prior to start of the study;
- No tumor progression after radiation therapy prior to start of the study;
- History or presence of serious cardiovascular abnormalities such as uncontrolled
hypertension, congestive heart failure NYHA classification of ≥ 3, unstable angina
or poorly controlled arrhythmia, and myocardial infarction within 6 months prior to
inclusion;
- Known pre-existing interstitial lung disease;
- No response after 2-week active treatment for known CTCAE Grade 3 or Grade 2
rash/acne;
- Any history or presence of poorly controlled gastrointestinal disorders that may
worsen after administration and could affect the absorption of the study drug (e.g.
diarrhea, Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption);
- Active hepatitis B infection (HepB sAg and/ or Hep B DNA positive), active hepatitis
C infection (Hep C RNA positive), active tuberculosis and/or known HIV carrier;
- Using other drugs that may influence afatinib and cannot be discontinued during the
study, including but not limited to:
- Potent P-gp inhibitors: including but not limited to ritonavir, cyclosporine A,
ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus,
nelfinavir, saquinavir and amiodarone);
- Potent P-gp inducers: including but not limited to rifampin, carbamazepine,
phenytoin, phenobarbital or St. John's wort).
- Pregnant or lactating women;
- Other invasive malignancies diagnosed within the last 5 years (except non-melanoma
skin cancer and localized cured prostate and cervical cancer);
- Any history of or concomitant condition that, in the opinion of the Investigator,
would compromise the patient's ability to comply with the study or interfere with
the evaluation of the efficacy and safety of the test drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Huashan Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Start date:
October 1, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Huashan Hospital
Agency class:
Other
Collaborator:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Huashan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519917