Trial of BI 6727 (Volasertib) Monotherapy and BI 6727 in Combination With Pemetrexed Compared to Pemetrexed Monotherapy in Advanced NSCLC

NCT ID: NCT00824408

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2015-08-31

Brief Summary

The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy.

The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 6727 +pemetrexed

BI 6727 plus 500 mg/\^m2 pemetrexed i.v. on day 1 of 21 day cycle

Group Type: EXPERIMENTAL

pemetrexed

Intervention Type: DRUG

500 mg/m\^2 i.v. on day 1 of 21 day cycle

BI 6727

Intervention Type: DRUG

BI 6727 i.v. on day 1 of a 21 day cycle

pemetrexed

500 mg/m\^2 i.v. on day 1 of a 21 day cycle

Group Type: ACTIVE_COMPARATOR

pemetrexed

Intervention Type: DRUG

500 mg/m\^2 i.v. on day 1 of 21 day cycle

Interventions

pemetrexed

500 mg/m\^2 i.v. on day 1 of 21 day cycle

Intervention Type: DRUG

pemetrexed

500 mg/m\^2 i.v. on day 1 of 21 day cycle

Intervention Type: DRUG

BI 6727

BI 6727 i.v. on day 1 of a 21 day cycle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Pathologic or cytologic confirmed diagnosis of NSCLC

2. Recurrent, advanced or metastatic NSCLC that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy)

3. Patients who are eligible for pemetrexed as second line chemotherapy

4. Measurable disease by one or more techniques (CT, MRI) according to RECIST

5. Patients aged 18 years or older

6. Life expectancy of at least three (3) months

7. Eastern Cooperative Oncology Group (ECOG) performance Score 0-2

8. Written informed consent that is consistent with ICH-GCP guidelines and local legislation

Exclusion Criteria

1. Treatment with an investigational drug in another clinical study within the past 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 past 28 days prior to Treatment Day 1 of Cycle 1 of this trial

3. Any persisting toxicities which are deemed to be clinically significant from the previous therapy

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

5. Patients who are 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 have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be 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 limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug

9. Patients unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily

10. Patients who have received prior therapy with pemetrexed

11. Absolute neutrophil count (ANC) less than 1,500/mm3

12. Platelet count less than 100,000/mm3

13. Hemoglobin <90g/L

14. Total bilirubin >26µmol/L

15. Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) less than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable

16. Serum creatinine level >133µmol/L and/or creatinine clearance (measured or calculated) <45 ml/min

17. Clinically relevant QTc prolongation

18. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception

19. Pregnancy or breast feeding

20. Known or suspected active alcohol or drug abuse

21. Patients unable to comply with the protocol

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

23. Patients with NSCLC of confirmed Squamous histology

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

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1230.5.00104 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

1230.5.00114 Boehringer Ingelheim Investigational Site

Kelowna, British Columbia, Canada

1230.5.00109 Boehringer Ingelheim Investigational Site

Surrey, British Columbia, Canada

1230.5.00107 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

1230.5.00105 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

1230.5.00119 Boehringer Ingelheim Investigational Site

Kitchener, Ontario, Canada

1230.5.00116 Boehringer Ingelheim Investigational Site

Oshawa, Ontario, Canada

1230.5.00108 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

1230.5.00110 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

1230.5.00102 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1230.5.00106 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1230.5.00118 Boehringer Ingelheim Investigational Site

Nassau, , The Bahamas

Countries

Canada; The Bahamas

References

Ellis PM, Leighl NB, Hirsh V, Reaume MN, Blais N, Wierzbicki R, Sadrolhefazi B, Gu Y, Liu D, Pilz K, Chu Q. A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Pemetrexed Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2015 Nov;16(6):457-65. doi: 10.1016/j.cllc.2015.05.010. Epub 2015 Jun 2.

Reference Type: DERIVED

PMID: 26100229 (View on PubMed)

Other Identifiers

1230.5

Identifier Type: -

Identifier Source: org_study_id