Non Small Cell Lung Cancer
Conditions
Keywords
NSCLC
Brief 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.
Detailed description
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.
Interventions
DRUGAXL1717
A repeated BID treatment for 14 days, followed by a 7 day observation period for two treatment periods
Sponsors
Axelar AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of AXL1717 in combination with Gemcitabine HCL and Carboplatin | End of two cycles, i.e. 6 weeks | 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. |
Countries
Sweden
Outcome results
None listed