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

Sponsor

Axelar AB (Industry)

Overall Status

Completed

CT.gov ID

NCT01466647

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: AXL1717	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Other: AXL1717 in combination with Gemcitabine HCL and Carboplatin

AXL1717 in combination with Gemcitabine HCL and Carboplatin

Drug: AXL1717

A repeated BID treatment for 14 days, followed by a 7 day observation period for two treatment periods

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KFUE	Uppsala		Sweden
2	University Hospital	Uppsala		Sweden

Sponsors and Collaborators

Axelar AB

Investigators

Principal Investigator: Michael Bergqvist, M.D., Ph.D, Uppsala University Hospital, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Axelar AB

ClinicalTrials.gov Identifier:

NCT01466647

Other Study ID Numbers:

AXL004

First Posted:

Nov 8, 2011

Last Update Posted:

Nov 12, 2012

Last Verified:

Nov 1, 2012

Keywords provided by Axelar AB

NSCLC

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Nov 12, 2012