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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

Phase 1
18 Years
Open (Enrolling by invite only)
Solid Tumors, Hematological Malignancies

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Trial Information

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 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 breakfast (fed treatment).

Inclusion Criteria:

1. Be informed of the nature of the study and have provided written informed consent

2. At least 18 years of age

3. Histologically confirmed diagnosis of advanced solid or hematological malignancy not
amenable to standard treatment.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 after optimization
of analgesics

5. Life expectancy ≥ 3 months

6. 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)

7. 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

8. 12-lead ECG with normal tracings; or changes that are not clinically significant and
do not require medical intervention

Exclusion Criteria:

1. Ongoing infection or other major recent or ongoing disease that, according to the
Investigator, poses an unacceptable risk to the patient

2. 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

3. 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.)

4. Impairment of gastrointestinal (GI) function, GI cancer or GI disease that may
significantly alter the absorption of AXL1717

5. 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

6. 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

7. Major surgical procedure within 4 weeks prior to randomization

8. Use of potent inhibitors of CYP2C9 (e.g. Fluconazole) from 3 weeks prior to first
administration of investigational product

9. 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.

10. Women who are breast-feeding or have a positive pregnancy test at screening

11. 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.

12. Known or suspected hypersensitivity to AXL1717

13. Lack of suitability for participation in the trial, for any reason, as judged by the

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

Single dose AXL1717 serum pharmacokinetic profile under fasting versus fed condition in each patient

Outcome Time Frame:

several samples within 24 hours

Safety Issue:


Principal Investigator

Michael Bergqvist, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Uppsala University Hospital, Sweden


Sweden: Medical Products Agency

Study ID:




Start Date:

October 2012

Completion Date:

June 2014

Related Keywords:

  • Solid Tumors
  • Hematological Malignancies
  • Neoplasms
  • Hematologic Neoplasms