Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma (NCT05041127) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma
United States29 participantsStarted 2022-05-27
Plain-language summary
This is a multicenter, single arm, phase 2 study designed to evaluate the efficacy and safety of cetuximab for the treatment of advanced (unresectable)/metastatic, chordoma. The target patient population will be any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years
* Histologically confirmed diagnosis of chordoma which is advanced (unresectable) and/or metastatic
* ECOG Performance Status of ≤ 2
* At least one site of measurable disease on x-ray/CT/MRI and/or PET/CT scan as defined by RECIST 1.1 criteria. Baseline imaging must be performed within 30 days of Day 1 of study.
* Adequate organ function within 28 days of Day 1 of study defined as:
* The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1000/µL, hemoglobin ≥ 9 g/dL (5.58 mmol/L), and platelets ≥ 100,000/µL
* The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L) (NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper Page 26 limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases).
* The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is \>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). 3.1.6 Patients may have any prior line of therapy, but there should a washout period of at least 3 weeks from any systemic therapy (small molecule/targeted agents, immunotherapies) and/or radiation therapy.…
What they're measuring
1
Overall response rate
Timeframe: through study completion, an average of 1 year