Dose Escalation Study of BI 2536 With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer

NCT ID: NCT02211833

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

Brief Summary

Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose (MTD), and efficacy of BI 2536 administered in combination with pemetrexed

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 2536 with pemetrexed

combination therapy phase may be followed by BI 2536 monotherapy for eligible patients

Group Type: EXPERIMENTAL

BI 2536

Intervention Type: DRUG

Pemetrexed

Intervention Type: DRUG

Interventions

BI 2536

Intervention Type: DRUG

Pemetrexed

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Pathologic or cytologic confirmed diagnosis of NSCLC

2. Recurrent, advanced or metastatic NSCLC that had progressed following 1 prior chemotherapy regimen for advanced disease. Patients could have received prior adjuvant chemotherapy as long as the disease free interval was longer than 1 year.

3. Measurable disease by 1 or more techniques (CT, MRI) according to RECIST criteria

4. Male or female aged 18 years or older

5. Life expectancy of at least 3 months

6. Eastern Cooperative Oncology Group (ECOG) performance score 0-2

7. Written informed consent that was consistent with International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) guidelines

Exclusion Criteria

1. Treatment with an investigational drug in another clinical study within the 28 days prior to the start of therapy or concomitantly with this study

2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the 28 days prior to Day 1 of treatment period 1 of this trial

3. Any persisting toxicities that were deemed to be clinically significant from the previous therapy

4. Received more than 1 prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients could have received prior epidermal growth factor receptor tyrosine kinase inhibitors

5. Unwilling or unable to take folic acid and vitamin B12 supplementation

6. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who had received prior whole brain irradiation and whose brain metastases were stable according to the criteria above were not excluded

7. Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer and cervical intraepithelial neoplasia)

8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would have limited compliance with trial requirement or which were considered relevant for the evaluation of the efficacy or safety of the trial drug

9. Unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to the day of and up to 2 days after the administration of pemetrexed

10. Received prior therapy with pemetrexed

11. Absolute neutrophil count (ANC) ≤1 500/μL, platelet count ≤100 000/μL, or haemoglobin <9 mg/dL

12. Total bilirubin >1.5 mg/dL (26 μmol/L), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2.5 x the upper limit of normal (ULN), except in cases of known liver metastasis where a maximum 5 x ULN was acceptable

13. Serum creatinine level >1.5 mg/dL and or creatinine clearance <45 mL/min

14. Sexually active and unwilling to use a medically acceptable method of contraception

15. Pregnancy or breast feeding

16. Known or suspected active alcohol or drug abuse

17. Unable to comply with the protocol

18. Any known hypersensitivity to the trial drugs or their excipients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1216.5

Identifier Type: -

Identifier Source: org_study_id