Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01329549
First received: April 1, 2011
Last updated: April 3, 2013
Last verified: April 2013

April 1, 2011
April 3, 2013
April 2011
October 2012   (final data collection date for primary outcome measure)
To determine Maximum tolerated dose of BIBF 1120 in combination with carboplatin and PLD based on number of Dose Limiting Toxicity (DLT) at each dose level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01329549 on ClinicalTrials.gov Archive Site
  • Frequency and intensity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and changes in safety laboratory parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Potential pharmacokinetic (PK) drug-drug interaction between BIBF 1120 and a combined administration of PLD and carboplatin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time to tumour progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Objective tumour response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Duration of objective tumour response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Serological progression-free interval (based on CA-125 mesurements) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)
An Open-label, Dose Escalation Phase I Study of the Safety and Tolerability of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Japanese Patients With a First, Second or Third Platinum-sensitive Relapse of Advanced Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer.

This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression is observed.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Neoplasms
  • Drug: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
    BIBF 1120 towice daily along with standard therapy of PLD + CBDCA
  • Drug: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
    BIBF 1120 towice daily along with standard therapy of PLD + CBDCA
  • Drug: BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
    BIBF 1120 towice daily along with standard therapy of PLD + CBDCA
  • Experimental: BIBF 1120 (low) + Carboplatin + PLD
    BIBF 1120 (low dose) + carboplatin (AUC5 mg/mL*min) + PLD (30 mg/m2)
    Intervention: Drug: BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
  • Experimental: BIBF 1120 (medium) + Carboplatin + PLD
    BIBF 1120 (medium dose) + carboplatin (AUC5 mg/mL*min) + PLD (30 mg/m2)
    Intervention: Drug: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
  • Experimental: BIBF 1120 (high) + Carboplatin + PLD
    BIBF 1120 (high dose) + carboplatin (AUC5 mg/mL*min) + PLD (30 mg/m2)
    Intervention: Drug: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Female patients, age 20 years or older, with relapse of histologically (on initial diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer
  2. Up to 3 lines of prior chemo therapy, with treatment free interval of >6 months
  3. Platinum based chemotherapy in the immediately preceding line.
  4. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
  5. Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines

Exclusion criteria:

  1. Prior chemotherapy with PLD, and any contraindication for therapy with carboplatin or PLD.
  2. More than 2 lines of prior therapies that contained angiogenesis inhibitor.
  3. Patients for whom surgery is planned, e.g. interval debulking surgery.
  4. History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
  5. Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy.
  6. Laboratory values indicating an increased risk for adverse events.
  7. Significant cardiovascular diseases.
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01329549
1199.117
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP