EUCTR2020-000923-37-IT
Active, not recruiting
Phase 1
A phase 1/2 study exploring the safety and activity of Trifluridine/tipiracil in combination with capecitabine and bevacizumab in metastatic colorectal cancer patients. - TriComB
G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST0 sites60 target enrollmentJune 8, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- metastatic colorectal cancer
- Sponsor
- G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Both Part 1 and 2:
- •\- Written informed consent to study procedures.
- •\- Histologically proven diagnosis of colorectal cancer.
- •\- Metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
- •\- At least one measurable lesion according to RECIST1\.1\.
- •\- Age \= 18 years.
- •\- ECOG PS \= 1\.
- •\- Life expectancy of at least 12 weeks.
- •\- Previous adjuvant fluoropyrimidine\-based chemotherapy allowed only if more than 12 months elapsed between the end of adjuvant and first relapse.
- •\- Availability of archival tumour tissue (primary tumour and metastases or at least one of the two) for biomarker analysis.
Exclusion Criteria
- •Radiotherapy to any site within 4 weeks before the study.
- •Previous treatment with trifluridine/tipiracil, bevacizumab and capecitabine (previous
- •treatment with capecitabine was permitted only in the adjuvant setting and if more than 12
- •months elapsed between the end of adjuvant and first relapse).
- •Untreated brain metastases or spinal cord compression or primary brain tumors.
- •History or evidence upon physical examination of CNS disease unless adequately treated.
- •Clinical signs of malnutrition.
- •Active uncontrolled infections or other clinically relevant concomitant illness
- •contraindicating chemotherapy administration.
- •Evidence of bleeding diathesis or coagulopathy.
Outcomes
Primary Outcomes
Not specified
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