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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define and confirm recommended Phase 2 dose

Safety Issue:

No

Principal Investigator

Michael Bergqvist, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Uppsala University Hospital

Authority:

Sweden: Regional Ethical Review Board

Study ID:

AXL-001

NCT ID:

NCT01062620

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Solid Tumors

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