Clinical trial NCT01062620: A Dose Escalating Clinical Trial of the IGF-1 Receptor Inhibitor AXL1717 in Patients With Advanced Cancer
Official title: A Dose Escalating Phase Ia-b Clinical Trial of the IGF-1 Receptor Inhibitor AXL1717 in Patients With Advanced Cancer: A Prospective, Single Armed, Open Label, Dose-finding Phase Ia-b Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Axelar AB
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

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.

Primary outcomes:
measure: To define and confirm recommended Phase 2 dose
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Michael Bergqvist, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.