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CompletedNCT01062620Updated Sep 15, 2011

A Dose Escalating Clinical Trial of the IGF-1 Receptor Inhibitor AXL1717 in Patients With Advanced Cancer

A Phase 1 interventional study of AXL1717 in Solid Tumors, sponsored by Axelar AB. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-15.

Sponsored by Axelar AB · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

A dose escalating phase Ia-b clinical trial of the IGF-1 receptor inhibitor AXL1717 in patients with advanced cancer.

The objective is to study the safety and pharmacokinetics of AXL1717 and to define an appropriate Phase 2 dose for further studies. This is the first study in man. The study is not designed to show tumor response.

02

Conditions studied

  • Solid Tumors
03

In context

Lead sponsor

Axelar AB is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. At least 18 years of age.
  2. Histologically confirmed diagnosis of advanced solid or haematological malignancy not amenable to standard treatment.
  3. Pharmacological treatment attempt justified
  4. Preserved major organ functions, i.e:

    • B-Leukocyte count ≥ 3.0 x 109/L
    • B-Neutrophil count ≥ 1.5 x 109/L
    • B-Platelet count ≥ 75 x109/L
    • B-Haemoglobin ≥ 100 g/L (transfusions are allowed)
    • P-Total bilirubin level ≤ 1.5 times the upper institutional limit of the "normal" (i.e. reference) range
    • P-ASAT or P-ALAT ≤ 2.5 times upper institutional limit of the "normal" range, ≤5 times if liver metastases have been documented
    • P-Creatinine ≤ 1.5 times upper institutional limit of the "normal" range
  5. Females of childbearing potential should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.
  6. Signed written informed consent.

Exclusion criteria

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 malignancy in CNS
  3. Prior anti-tumour therapy within 4 weeks from enrolment (6 weeks for nitrosurea and MitC).
  4. Pregnancy or lactation
  5. Current participation in any other interventional clinical trial
  6. Performance status > ECOG 2 after optimization of analgesics
  7. Life expectancy less than 3 months
  8. Contraindications to the investigational product, e.g. known or suspected hypersensitivity.
  9. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    AXL1717

    Drug: AXL1717

Interventions

  • DrugAXL1717

    Phase I study with increasing dosage and treatment duration

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What researchers measure

Primary outcomes

  1. To define and confirm recommended Phase 2 dose

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Study locations

1 site
  • Uppsala University Hospital
    Uppsala, SE-75185, Sweden
08

References and documents

Publications

  • Ekman S, Harmenberg J, Frodin JE, Bergstrom S, Wassberg C, Eksborg S, Larsson O, Axelson M, Jerling M, Abrahmsen L, Hedlund A, Alvfors C, Stahl B, Bergqvist M. A novel oral insulin-like growth factor-1 receptor pathway modulator and its implications for patients with non-small cell lung carcinoma: A phase I clinical trial. Acta Oncol. 2016;55(2):140-8. doi: 10.3109/0284186X.2015.1049290. Epub 2015 Jul 10. PubMed 26161618 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01062620
Lead sponsor
Axelar AB
First posted
Feb 4, 2010
Start date
Apr 2008
Primary completion
May 2011
Last update
Sep 15, 2011

Study contacts

Michael Bergqvist, MD
principal investigator · Uppsala University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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