Oral Paclitaxel for Patients with Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnoUp Farma S.L.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients; age ≥ 18 years at the time of study entry.
Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Patients for which standard therapy does not exist or is no longer effective.
ECOG ≤ 2.
Disqualifiers
Simultaneous enrollment in another clinical study unless it is an observational (non-interventional) study or the follow-up period of an interventional study.
History of severe allergic reactions (ie, Grade 4 allergy, anaphylactic reaction from which the patient did not recover within 6 hours of institutional supportive care) to an unknown allergen or any components of the study drug formulations.
Patients with dysphagia or disorders in gastrointestinal function.
Previous hypersensitive reaction to taxanes.
Trial design
Design model
Sequential
Treatments tested in this trial
INP12
DrugOral paclitaxel
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: INP12Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
• MTD determination
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 weekly in patients with advanced solid tumors.
Time frame
28 days2
• Incidence of INP12 Adverse Events (Safety and tolerability profile of INP12)
Tolerability will be defined by the number of patients experiencing any dose limiting toxicity (DLT) during the first 28-day cycle of INP12. Safety of INP12 will be assessed on the incidence rate, severity, and relationship to treatment of adverse events (AEs) and serious adverse events (SAEs) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.03 (see Appendix 15.2). Other assessments will include safety laboratory parameters, vital signs, and electrocardiograms (ECG) in each dose group and in the expansion phase.
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov