Solid TumorsPhase 1NCT01725555
A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors
A Phase 1 study testing Fasted treatment: AXL1717 and Fed treatment: AXL1717 in people with Solid Tumors and Hematological Malignancies, run by Axelar AB at 1 site in Sweden.
Trial summary
This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect of food on the bioavailability of AXL1717 including patients with advanced malignant tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Hematological Malignancies
- What is being tested?
- Fasted treatment: AXL1717 and Fed treatment: AXL1717
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Life expectancy ≥ 3 months
- Hematology values: blood leukocyte count ≥ 3.0 x 109/L, blood absolute neutrophil count ≥ 1.5 x 109/L, blood platelet count ≥ 100 x109/L, hemoglobin ≥ 100 g/L (transfusions are allowed)
- Clinical chemistry values: plasma total bilirubin level ≤ 1.5 times the upper limit of the "normal" range (ULN; i.e. reference), plasma AST or ALT ≤ 1.5 x ULN (≤5 times if liver metastases have been documented) and plasma creatinine ≤ 1.5 x ULN
- 12-lead ECG with normal tracings; or changes that are not clinically significant and do not require medical intervention
Who cannot join
- 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
- Coexisting uncontrolled medical condition, including active cardiac disease (such as unstable angina, myocardial infarction within 6 months, or New York Heart Association Class III/IV congestive heart failure), or significant dementia
- Hepatic impairment as indicated by abnormalities of transaminases and/or alkaline phosphatase (AST and/or ALT > 1.5 × upper limit of normal concomitant with alkaline phosphatase > 2.5 × upper limit of normal, ≤5 times if liver metastases have been documented)
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- Major surgical procedure within 4 weeks prior to randomization
- Use of potent inhibitors of CYP2C9 (e.g. Fluconazole) from 3 weeks prior to first administration of investigational product
- Women of child bearing potential (WOCBP) who do not consent to using acceptable methods of contraception (i.e. two of the following - oral contraception, barrier contraception, intrauterine device). For purposes of this study, WOCBP include any female who has experienced menarche, who has not undergone tubal ligation, and who is not postmenopausal. Post menopause is defined as: amenorrhea ≥ 12 consecutive months without another cause.
- Women who are breast-feeding or have a positive pregnancy test at screening
- Current participation in any other investigational clinical trial or any administration of an investigational agent within 4 weeks of study drug administration or 10 half-lives of the investigational agent, whichever is longer. Patients with unresolved investigational treatment-related AEs may not participate.
- Known or suspected hypersensitivity to AXL1717
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect of food on the bioavailability of AXL1717 including patients with advanced malignant tumors
Read the detailed description
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).
- Conditions
- Solid Tumors, Hematological Malignancies
- Being tested
- Fasted treatment: AXL1717, Fed treatment: AXL1717
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasted treatment: AXL1717Drug
Fed treatment: AXL1717Drug
| Study group | Role | What they receive |
|---|---|---|
| Fasted treatment | Experimental | Not described Receives: Drug: Fasted treatment: AXL1717; Drug: Fed treatment: AXL1717 |
| Fed treatment | Experimental | Not described Receives: Drug: Fasted treatment: AXL1717; Drug: Fed treatment: AXL1717 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single dose AXL1717 serum pharmacokinetic profile under fasting versus fed condition in each patient
Measured: several samples within 24 hours
Secondary outcomes (1)
Safety of AXL1717 through adverse event reporting
Measured: Up to 30 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axelar AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Ekman, M.D., Ph.D., Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725555
- Sponsor's protocol ID
- AXL010
- Status last verified
- Apr 2014
- First submitted
- 26 Oct 2012
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01725555
- Acronym / sponsor ID
- AXL010
- Conditions
- Solid Tumors, Hematological Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Axelar ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, open-label, Phase I, crossover study to assess the effect of food on the bioavailability of AXL1717 including patients with advanced malignant tumors
Detailed description
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).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasted treatment | Experimental | Drug: Fasted treatment: AXL1717, Drug: Fed treatment: AXL1717 |
| Fed treatment | Experimental | Drug: Fasted treatment: AXL1717, Drug: Fed treatment: AXL1717 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Life expectancy ≥ 3 months
Key exclusion criteria (13 listed)
- 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
- Coexisting uncontrolled medical condition, including active cardiac disease (such as unstable angina, myocardial infarction within 6 months, or New York Heart Association Class III/IV congestive heart failure), or significant dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasted treatment: AXL1717 | Drug | Fasted treatment, Fed treatment |
| Fed treatment: AXL1717 | Drug | Fasted treatment, Fed treatment |
Primary outcome
Single dose AXL1717 serum pharmacokinetic profile under fasting versus fed condition in each patient
Time frame: several samples within 24 hours
1 secondary outcome
Safety of AXL1717 through adverse event reporting
Time frame: Up to 30 days after last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Ekman, M.D., Ph.D. principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fasted treatment: AXL1717 and Fed treatment: AXL1717 in people with Solid Tumors and Hematological Malignancies, run by Axelar AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single dose AXL1717 serum pharmacokinetic profile under fasting versus fed condition in each patient (time frame: several samples within 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.