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

Study Overview
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Brief Summary
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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.

Detailed Description
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Open single-center, explorative, Phase I pilot study including patients treated with AXL1717 in addition to standard chemotherapy of gemcitabine HCL and carboplatin. Patients will be treated within the study for 2 treatment cycles of 3 weeks each. Survival data will be obtained. Tumor assessment will be conducted at baseline and then at the end of the study period. Concomitant supportive therapies will be allowed.

Official Title
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A Phase I Pilot Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin in Previously Untreated, Locally Advanced, or Metastatic Squamous Non-small-cell Lung Cancer

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: AXL1717


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age. 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) 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AXL1717 in combination with Gemcitabine HCL and Carboplatin<br>AXL1717 in combination with Gemcitabine HCL and Carboplatin | Drug: AXL1717<br>* A repeated BID treatment for 14 days, followed by a 7 day observation period for two treatment periods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of AXL1717 in combination with Gemcitabine HCL and Carboplatin | A dose finding pilot study to evaluate safety and pharmacokinetics in combination with Gemcitabine HCL and Carboplatin during two treatment cycles, i.e. 6 weeks. | End of two cycles, i.e. 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC