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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00969761
First received: August 31, 2009
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: BI-6727
Drug: BI 6727
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Trial of BI 6727 in Combination With Cisplatin or Carboplatin in Patients With Advanced or Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Determination of the Maximum Tolerated Dose (MTD) of the BI 6727 combination treatment with cisplatin or carboplatin. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and intensity of drug-related adverse events according to common terminology criteria for adverse events (CTCAE) v.3.0, incidence of DLT, laboratory evaluations, patient performance and vital signs. [ Time Frame: from 1st treatment until 3 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of BI 6727 in combination with cisplatin or carboplatin. [ Time Frame: from 1st treatment until 3 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Objective response rate and progression-free survival after BI 6727 treatment based on RECIST criteria. [ Time Frame: from 1st treatment until 3 weeks after end of treatment ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: August 2009
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A. BI 6727-cisplatin
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin
Drug: BI 6727
low to high dose
Experimental: B. BI 6727-carboplatin
patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin
Drug: BI-6727
Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969761

Locations
Belgium
1230.6.3201 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1230.6.3202 Boehringer Ingelheim Investigational Site
Leuven, Belgium
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00969761     History of Changes
Other Study ID Numbers: 1230.6, 2008-003926-40
Study First Received: August 31, 2009
Last Updated: July 25, 2012
Health Authority: Belgium: Federal Agency for Medicinal and Health Products

Additional relevant MeSH terms:
Neoplasms
Cisplatin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014