Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT03418558
Eligibility Criteria:
Inclusion Criteria:
1. Histological/confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery.
2. Progression (PD) during or after therapy with anti-HER2 therapy including those in HERACLES trial cohort A (trastuzumab and lapatinib) within the HERACLES - A trial.
3. ECOG PS \< 2
4. Measurable disease as defined by RECIST 1.1 criteria
5. Adequate hematological function as defined by: ANC \>= 1.5 x 10\^9/L, platelet count \>=100 x 10\^9/L, hemoglobin \>= 10 g/dL.
6. Adequate renal function, as defined by: creatinine \>= 1.5 x UNL
7. Adequate hepatobiliary function, as defined by the following baseline liver function tests:
1. total serum bilirubin \>=1.5 upper normal limit (UNL) (unless documented Gilbert's syndrome )
2. alanine aminotransferase (ALT), aspartate aminotransferase (AST) \>= 2.5xUNL
3. alkaline phosphatase (AP) \>= 2.5xUNL; if total alkaline phosphatase (AP) \> 2.5xUNL, alkaline phosphatase liver fraction must be \>= 2.5xUNL
8. Adequate contraception for all fertile patients
9. Negative pregnancy test.
Exclusion Criteria:
1. Symptomatic brain metastases
2. Active infection
3. Interval from last anti HER2 therapy \< 2 weeks. Patients in treatment with T-DM1 (provided by third-parties) may be eligible for immediate treatment if not in progression at the time of protocol entry.
4. Prior chemotherapy \<4 weeks.
5. Impaired cardiac function including any of the following: uncontrolled hypertension (systolic \>150 mmHg and/or diastolic \> 100 mmHg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication; unstable angina; chronic heart failure (CHF) of New York Heart Association (NYHA) Grade II or higher; or serious cardiac arrhythmia requiring medication, baseline Left Ventricular Ejection Fraction (LVEF) ≤ 55% measured by echocardiography (ECHO)
6. Major surgery in the two weeks prior to entering the clinical trial
7. Concurrent treatment with any other anti-cancer therapy
8. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons
9. Pregnant and lactating women
10. Men and women of childbearing potential who are not using an effective method of contraception
11. Participation in another clinical trial
12. Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03418558
Study Brief:
Protocol Section:
NCT03418558