A phase 2, single arm, European multi-center trial evaluating the efficacy of afatinib as first-line or later-line treatment in advanced chordoma.

Phase 2

Completed

• Conditions: no synonym; 10040778

• Registration Number: NL-OMON54671
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Locally advanced or metastatic, pathologically proven, EGFR expressing
chordoma, not amenable for local therapies , - Patients of 18 years and up , -
Documented radiographic progression of disease according to RECIST 1.1 criteria
in last 6 months, with interval between 2 pre-treatment scans of <= 6 months -
ECOG Performance status <= 2 , - 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, - Total Bilirubin <= 1.5 times upper limit of normal (ULN) (Patients
with Gilbert*s syndrome total bilirubin must be <=4 times institutional upper
limit of normal)., - Aspartate amino transferase (AST) or alanine amino
transferase (ALT) <= 3 times ULN (if related to liver metastases <= 5 times ULN),
- Ability to swallow medication, - Recovered from any previous therapy related
toxicity to <= grade 1 at study entry (except for stable sensory neuropathy <=
grade 2 and alopecia), - Availability of archival tumor material for review (if
not please obtain a new tumor biopsy), - Written signed informed consent, -
Ability to adhere to the study visits and all protocol requirements

Exclusion Criteria

- Life expectancy of less than 3 months, - No measurable lesions according to
RECIST 1.1, - Known hypersensitivity to afatinib, - Major surgery less than 4
weeks prior to start of treatment , - Previous treatment with any other
investigational agents within 14 days of first day of study drug dosing , -
History or presence of clinically relevant cardiovascular abnormalities such as
uncontrolled hypertension, congestive heart failure NYHA classification of >= 3,
unstable angina or poorly controlled arrhythmia as determined by the
investigator. Myocardial infarction within 6 months prior to inclusion., -
Known pre-existing interstitial lung disease, - Any history or presence of
poorly controlled gastrointestinal disorders that could affect the absorption
of the study drug (e.g. Crohn*s disease, ulcerative colitis, chronic diarrhea,
malabsorption) , - Known active hepatitis B infection (defined as presence of
HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence
of Hep C RNA) and/or known HIV carrier., - Systemic anti-cancer therapy within
28 days prior to the first dose of study drug , or radiotherapy to an index (or
target)lesion within 21 days prior to the first dose of study drug , -
Requiring treatment with any of the prohibited concomitant medications listed
in Section 6.3.9 that cannot be stopped for the duration of trial
participation, - 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified