Status:
COMPLETED
A Study of the IGF-1R Inhibitor AXL1717 in Combination With Gemcitabine HCL and Carboplatin to Treat Non-small-cell Lung Cancer (NSCLC)
Lead Sponsor:
Axelar AB
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01466647
Start Date
January 1 2011
End Date
September 1 2012
Last Update
November 12 2012
Active Locations (2)
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1
KFUE
Uppsala, Sweden
2
University Hospital
Uppsala, Sweden