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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AXL1717

Group Type EXPERIMENTAL

AXL1717

Intervention Type DRUG

Phase I study with increasing dosage and treatment duration

Interventions

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AXL1717

Phase I study with increasing dosage and treatment duration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No