A Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin to Treat Non-small-cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a open single-center, explorative, Phase I pilot dose finding study including patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and carboplatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axelar AB
• Treatments: Carboplatin; Gemcitabine

Criteria

Inclusion Criteria:

1. At least 18 years of age.

2. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic squamous non-small-cell lung cancer (stage IIIB or IV) and scheduled for treatment with cytotoxic chemotherapy (Gemcitabine HCL/Carboplatin)

3. 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

• 12-lead ECG with normal tracings; or clinically nonsignificant changes that did not require medical intervention

4. Signed written informed consent.

Exclusion Criteria:

• The presence of any of the following criteria will exclude the patient from participating in the study:

• Ongoing infection or other major recent or ongoing disease that, according to the investigator, poses an unacceptable risk to the patient

• 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.)

• Known malignancy in Central Nervous System (CNS)

• Disease and dementia and neuropathy grade more than 1

• Other active malignancy during the previous 3 years

• Major surgical procedure within 4 weeks

• Prior anti-tumor therapy apart from radiation therapy

• Women Of Child Bearing Potential (WOCBP) - For purposes of this study, WOCBP include any female who has experienced menarche and who is not postmenopausal. Post menopause is defined as: Amenorrhea ≥ 12 consecutive months without another cause

• Pregnancy or lactation

• Current participation in any other interventional clinical trial

• Performance status > ECOG 2 after optimization of analgesics

• Life expectancy less than 3 months

• Contraindications to the investigational product, e.g. known or suspected hypersensitivity.

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