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
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.