Actively Recruiting
Oral Paclitaxel for Patients with Advanced Solid Tumors
Led by InnoUp Farma S.L. · Updated on 2024-09-19
70
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase I trial evaluating the safety, tolerability, and pharmacokinetic profile of INP12, a nanoparticles-based oral paclitaxel, in patients with advanced solid tumors The aim in Part A (Escalation phase) is to determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (in the absence of exceeding the MTD)and the recommended phase II dose (RP2D) of INP12 administered orally once a week during three consecutive weeks under a 28-day cycle in patients with advanced solid tumors. The aim in Part B (Expansion phase) is to assess the safety and tolerability of INP12 as monotherapy at the RP2D or highest protocol-defined dose in patients with selected advanced solid tumors.
CONDITIONS
Official Title
Oral Paclitaxel for Patients with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 years or older
- Written informed consent obtained before any study procedures
- Histologically or cytologically confirmed advanced or metastatic solid tumor (Part A)
- Advanced or metastatic solid tumor with at least 50% breast cancer patients (Part B)
- No effective standard therapy available or standard therapy has failed
- ECOG performance status of 0 to 2
- Life expectancy of at least 12 weeks
- No growth factors or blood transfusions within 28 days prior to first INP12 dose
- Adequate organ and spinal function, including specific blood counts and liver/kidney function
- Measurable or evaluable tumor lesion
- Females of childbearing potential must use highly effective contraception during and 90 days after treatment
- Male partners of female patients must use condoms plus spermicide during and 90 days after treatment
- Patients able and willing to comply with study procedures and periodic blood tests
You will not qualify if you...
- Enrolled in another interventional clinical study (except observational studies)
- History of severe allergic reactions to unknown allergens or study drug components
- Dysphagia or gastrointestinal disorders affecting drug intake or absorption
- Previous hypersensitivity to taxanes or corn
- Concurrent systemic chemotherapy, hormonal therapy, or immunotherapy for cancer
- Use of cytochrome P-450 3A4 or P-glycoprotein 1 inhibitors or inducers
- Use of immunosuppressive drugs within 28 days prior to first INP12 dose (except certain corticosteroids)
- Received any anticancer therapy within 28 days prior to first INP12 dose
- Primary CNS tumor or untreated CNS metastases (with some exceptions)
- History of malignant tumors within last 2 years (except certain non-invasive cancers)
- Unresolved adverse events from prior cancer treatments above specified severity
- Pregnant or breastfeeding women
- Known HIV infection or active hepatitis B, C, or A
- Major surgery within 4 weeks prior to first INP12 dose or still recovering
- Severe or uncontrolled medical conditions that could affect study compliance or safety
- Any condition that could interfere with study evaluation or follow-up according to the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
VHIO
Barcelona, Catalonia, Spain
Actively Recruiting
Research Team
M
Maite Agüeros, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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