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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase I Open-label Dose Escalation Study of Intravenous BI 2536 Together With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211833
• Other study ID #: 1216.5
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2014
• Last updated: August 7, 2014
• Start date: October 2006

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Public Health Agency of Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• BI 2536

• Pemetrexed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) of BI 2536 in combination with pemetrexed	by occurrence of dose limiting toxicities (DLT)	up to 3 weeks	No
Primary	Number of patients with adverse events during combination therapy	according to common terminology criteria for adverse events (CTCAE) 3.0	up to 20 weeks	No
Secondary	Objective tumor response after combination therapy	according to Response Evaluation Criteria in Solid Tumours (RECIST)	up to 20 weeks	No
Secondary	Duration of objective tumor response after combination therapy		up to 1 year	No
Secondary	Progression free survival (PFS)		up to 2 years	No
Secondary	Overall survival		up to 2 years	No
Secondary	Number of patients with abnormal laboratory findings		up to 20 weeks	No
Secondary	Change in Eastern Cooperative Oncology Group (ECOG) performance score		baseline, up to 1 year	No

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