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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: BI 6727; Drug: BI-6727

Study type: Interventional

Funder types: Industry

Identifiers

NCT00969761

2008-003926-40 (EudraCT Number)

1230.6

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

61 participants in 2 patient groups

A. BI 6727-cisplatin

Experimental group

Description:

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

Treatment:

Drug: BI 6727

B. BI 6727-carboplatin

Experimental group

Description:

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

Treatment:

Drug: BI-6727