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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00969761
• Date of registration: 31/08/2009
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: BI 6727 (Volasertib) in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumour
• Scientific title: A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumors
• Date of first enrolment: August 2009
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00969761
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neoplasms

Intervention(s)

Drug: BI-6727

Drug: BI 6727

Primary Outcome(s)

Maximum Tolerated Dose [Time Frame: 3 weeks]

Secondary Outcome(s)

Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Platelets [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Progression-free Survival [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Best Overall Response [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Worst CTCAE Grade on Treatment for Neutrophils [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Last Value on Treatment [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Neutrophils Based on Worst Value on Treatment [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Incidence and Intensity of Adverse Events According to CTCAE Version 3.0 [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Worst CTCAE Grade on Treatment for Platelets [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Change From Baseline in Neutrophils [Time Frame: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Duration of Disease Control [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Objective Response Rate [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Total Plasma Clearance After Intravascular Administration (CL) [Time Frame: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion]

Frequency of Participants (%) With Possible Clinically Significant Abnormalities for Neutrophils [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Last Value on Treatment [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Apparent Volume of Distribution at Steady State Following Intravascular Administration (Vss) [Time Frame: 1 hour (h) 35 minutes (min) before start of volasertib infusion and 1h, 2h, 8h, 24h, 48h, 168h and 336h after start of volasertib infusion]

Change From Baseline in Platelets [Time Frame: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Percentage of Participants With Serious Adverse Events [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Change From Baseline in Pulse Rate [Time Frame: Baseline and from first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Disease Control Rate [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Duration of Objective Response [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Frequency of Participants With Transitions Relative to the Baseline CTC Grade for Platelets Based on Worst Value on Treatment [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Percentage of Participants With Dose Limiting Toxicities [Time Frame: 3 weeks]

Percentage of Participants With Significant Adverse Events [Time Frame: From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days]

Secondary ID(s)

2008-003926-40

1230.6

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00969761