Actively Recruiting
Galunisertib Combined With Capecitabine in Advanced CRC With PM
Led by The Netherlands Cancer Institute · Updated on 2024-07-22
31
Participants Needed
2
Research Sites
87 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
A
Amsterdam UMC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a two-center open-label non-randomized proof of principle study consisting of a dose-finding part (phase I) and phase II study with Simon two-stage design investigating the anti-tumor activity of the combination of capecitabine and galunisertib in patients with colorectal cancer with peritoneal metastases.
CONDITIONS
Official Title
Galunisertib Combined With Capecitabine in Advanced CRC With PM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of colorectal cancer with peritoneal metastases (other metastases allowed)
- Disease progressed or relapsed after fluoropyrimidine-containing chemotherapy for advanced colorectal cancer
- Age 18 years or older
- Able and willing to provide written informed consent
- WHO performance status of 0 or 1
- Willing to undergo blood sampling for pharmacokinetic analysis
- Willing to undergo tumor biopsies before, during, and after treatment
- Life expectancy greater than 3 months
- Measurable disease for phase II; evaluable disease for phase I according to RECIST 1.1
- Adequate laboratory safety values including ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, liver and kidney function within specified limits
- Negative pregnancy test for women of childbearing potential
- Able and willing to swallow tablets
You will not qualify if you...
- Treatment with investigational drugs within 30 days or recent radio- or chemotherapy within 2 weeks before study start (except palliative radiation 1x 8Gy, excluding liver-focused radiotherapy)
- Known or suspected complete or partial dihydropyrimidine dehydrogenase deficiency
- Symptomatic or untreated leptomeningeal disease
- Symptomatic brain metastases (stable, asymptomatic brain metastases allowed under specific conditions)
- Recent serious cardiac conditions or unstable heart disease
- Use of certain enzyme-inducing or inhibiting drugs affecting study drug metabolism
- Gastrointestinal disorders affecting drug absorption
- Pregnancy or breastfeeding
- Major surgery within 2 weeks before starting study treatment
- Active infection requiring systemic antibiotics or uncontrolled infection
- Known hepatitis B, C, or HIV infection
- Other severe medical or psychiatric conditions increasing risk or interfering with study
- Known allergy to study drugs or ingredients
- For women of childbearing potential: agreement to use highly effective contraception or abstinence during treatment and 90 days after
- For men: agreement to use contraception or abstinence and refrain from sperm donation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
Actively Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands, 1081 HV
Not Yet Recruiting
Research Team
A
Alaa Embaby, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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