Completed
A Randomized, Open-label, Phase I, Crossover Study to Assess the Effect of Food on the Bioavailability of AXL1717, in Patients With Advanced Malignant Tumors
What is being tested
Fasted treatment: AXL1717
+ Fed treatment: AXL1717
Drug
Who is being recruted
Hematologic Diseases+2
+ Hemic and Lymphatic Diseases
+ Neoplasms
Over 18 Years
+21 Eligibility Criteria
How is the trial designed
Phase 1
Interventional
Study Start: October 2012
Summary
Principal SponsorAxelar AB
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.This is a randomized, crossover, open label, phase I study to assess the effect of food on the bioavailability of AXL1717 in advanced cancer patients. A single, oral dose of AXL1717 is to be administered to patients on each of two occasions that are 7-day apart, in random order: after an overnight fast (fasted treatment) and with a high-fat or moderate-fat breakfast (fed treatment).
Official TitleA Randomized, Open-label, Phase I, Crossover Study to Assess the Effect of Food on the Bioavailability of AXL1717, in Patients With Advanced Malignant Tumors
Principal SponsorAxelar AB
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
13 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasmsNeoplasms by SiteHematologic Neoplasms
Criteria
8 inclusion criteria required to participate
Be informed of the nature of the study and have provided written informed consent
At least 18 years of age
Histologically confirmed diagnosis of advanced solid or hematological malignancy not amenable to standard treatment.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 after optimization of analgesics
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13 exclusion criteria prevent from participating
Ongoing infection or other major recent or ongoing disease that, according to the Investigator, poses an unacceptable risk to the patient
Known primary or secondary central nervous system malignancy. (Patients with symptoms suggestive of possible CNS metastasis such as headache, dizziness or focal neurological deficits should undergo CT or MRI of the brain to rule out CNS metastasis. Patients who do not have CNS symptoms do not need a CT or MRI of the brain.)
Grade 3 or higher constipation within the past 28 days or grade 2 constipation within the past 14 days before randomization. (Patients with grade 2 constipation within the past 14 days could be re-screened if constipation decreases to ≤ grade 1 with optimal management of constipation.)
Impairment of gastrointestinal (GI) function, GI cancer or GI disease that may significantly alter the absorption of AXL1717
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center