BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour

NCT ID: NCT00969761

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-02-29

Brief Summary

The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events when combined with a platinum therapy (cisplatin or carboplatin).

Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.

Conditions

Neoplasms

Study Design

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

Study Groups

A. BI 6727-cisplatin

patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin

Group Type: EXPERIMENTAL

BI 6727

Intervention Type: DRUG

low to high dose

B. BI 6727-carboplatin

patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin

Group Type: EXPERIMENTAL

BI-6727

Intervention Type: DRUG

Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added

Interventions

BI-6727

Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added

Intervention Type: DRUG

BI 6727

low to high dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment

2. Indication for a treatment with platinum therapy as judged by the investigator

3. Age 18 years or older

4. Written informed consent consistent with ICH-GCP and local legislation

5. ECOG performance score lower or equal 2

6. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)

Exclusion Criteria

1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol

2. Pregnancy or breastfeeding

3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II

4. Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months

5. Second malignancy currently requiring another anti-cancer therapy

6. ANC less than 1500 / mm3

7. Platelet count less than 100 000 / mm3

8. Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome)

9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)

10. Serum creatinine greater than 1.5 mg / dl (> 132 micromol / L, SI unit equivalent) or creatinine clearance <70ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate)

11. Known history of relevant QT-prolongation, e.g. long QT-syndrome

12. Pre-existing clinically relevant hearing loss

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

14. Treatment with other investigational drugs or participation in another clinical interventional trial within the past four weeks before start of therapy or concomitantly with this trial

15. Systemic anti-cancer therapy or radiotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.

16. Patients unable to comply with the protocol

17. Active alcohol or drug abuse

• 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

1230.6.3201 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

1230.6.3202 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Countries

Belgium

References

Awada A, Dumez H, Aftimos PG, Costermans J, Bartholomeus S, Forceville K, Berghmans T, Meeus MA, Cescutti J, Munzert G, Pilz K, Liu D, Schoffski P. Phase I trial of volasertib, a Polo-like kinase inhibitor, plus platinum agents in solid tumors: safety, pharmacokinetics and activity. Invest New Drugs. 2015 Jun;33(3):611-20. doi: 10.1007/s10637-015-0223-9. Epub 2015 Mar 22.

Reference Type: DERIVED

PMID: 25794535 (View on PubMed)

Other Identifiers

2008-003926-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1230.6

Identifier Type: -

Identifier Source: org_study_id