BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01314105
First received: March 8, 2011
Last updated: April 2, 2014
Last verified: April 2014

March 8, 2011
April 2, 2014
March 2011
July 2013   (final data collection date for primary outcome measure)
Maximum Tolerated Dose of BIBF 1120 in combination with carboplatin and pegylated liposomal doxorubicin based on the occurrence of DLTs during treatment course 1 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Maximum Tolerated Dose of BIBF 1120 in combination with carboplatin and pegylated liposomal doxorubicin [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01314105 on ClinicalTrials.gov Archive Site
  • Determination of pharmacokinetic (PK) parameters of PLD (total plasma doxorubicin and doxorubicinol) [ Time Frame: 49 days ] [ Designated as safety issue: No ]
  • Determination of pharmacokinetic (PK) parameters of Carboplatin (ultrafiltrable and/or total platinum) [ Time Frame: 49 days ] [ Designated as safety issue: No ]
  • Frequency of all adverse events graded by CTCAE (Common Terminology Criteria for Adverse Events) version 3.0 and changes in safety laboratory parameters [ Time Frame: 50 months ] [ Designated as safety issue: No ]
  • Determination of pharmacokinetic (PK) parameters of BIBF 1120, BIBF 1202 and BIBF 1202 glucuronide [ Time Frame: 48 days ] [ Designated as safety issue: No ]
  • Frequency of all adverse events graded by CTCAE (Common Terminology Criteria for Adverse Events) version 3.0 and changes in safety laboratory parameters [ Time Frame: 16 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: 16 months ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Time to Tumour Progression [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Objective Tumour Response [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Serological Progression-free interval [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
BIBF 1120 + Carboplatin/Pegylated Liposomal Doxorubicin (PLD) in Patients With Advanced Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Cancer
Phase I Dose Escalation Trial to Determine the Maximum Tolerated Dose of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in 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.

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
  • Peritoneal Neoplasms
  • Drug: BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
    BIBF1120 twice daily along with standard therapy of PLD + carboplatin
  • Drug: BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
    BIBF1120 twice daily along with standard therapy of PLD + carboplatin
  • Experimental: BIBF 1120 L+ Carboplatin + PLD
    BIBF 1120 (100 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) + PLD (30 mg/m2)
    Intervention: Drug: BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
  • Experimental: BIBF 1120 M + Carboplatin + PLD
    BIBF 1120 (150 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) + PLD (30 mg/m2)
    Intervention: Drug: BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
  • Experimental: BIBF 1120 H + Carboplatin + PLD
    BIBF 1120 (200 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) + PLD (30 mg/m2)
    Intervention: Drug: BIBF 1120+ 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.
 
Active, not recruiting
24
May 2015
July 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Female patients, age 18 years or older, with a first, second or third relapse of histologically (on initial diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer
  2. Up to three lines of prior chemo (chemotherapy before and after interval surgery to be counted as one line therapy), with treatment free interval of > 6 months (= time between last administration of prior anti-cancer treatment, including chemotherapy, hormonal therapy, or radiation therapy, and diagnosis of progressive disease)
  3. Platinum based chemo in immediately preceding line
  4. Eligibility for treatment with i.v. chemotherapy regimen of carboplatin AUC 5 and PLD 30 mg/m2 every 4 weeks
  5. Life expectancy of at least 3 months
  6. Written informed consent that is consistent with International Conference of Harmonisation (ICH)-Good Clinical Practice (GCP) guidelines
  7. Eastern Cooperative Oncology Group (ECOG) performance score 0 or1
  8. Prior treatment with angiogenesis inhibitor (bevacizumab, TKI inhibiting VEGFR-2) is allowed provided treatment with bevacizumab has been discontinued = 28 days prior to start of therapy and treatment with the TKI has been discontinued = 3 months prior to start of therapy, provided anti-angiogenic therapy was added to only one of the preceding lines of therapy

Exclusion criteria:

  1. Prior chemotherapy with doxorubicin (any formulation, liposomal or non-liposomal doxorubicin).
  2. Any contraindications for therapy with PLD or carboplatin, e.g. a history of hypersensitivity reactions to platinum-containing compounds and their excipients.
  3. Hypersensitivity to active substance or to any of the excipients of BIBF 1120.
  4. Treatment with other investigational drugs or participation in another clinical trial testing a drug within the past four weeks before start of therapy or concomitantly with this trial (exception: for previous treatment with angiogenesis inhibitors, cf. inclusion criterion #8).
  5. Laboratory values indicating an increased risk for adverse events.
  6. Major surgery within 4 weeks prior to start of study treatment.
  7. Patients for whom surgery is planned, e.g. interval debulking surgery.
  8. Clinically relevant non-healing wound, ulcer (intestinal tract, skin) or bone fracture.
  9. Clinical symptoms or signs of gastrointestinal obstruction that require parenteral nutrition or hydration.
  10. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
  11. History of clinical symptoms of brain metastases.
  12. Prior thrombosis or thromboembolic event in the presence of an inherited coagulopathy.
  13. History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
  14. Known inherited or acquired bleeding disorder.
  15. Significant cardiovascular diseases.
  16. Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy.
  17. Other malignancy diagnosed within the past 5 years.
  18. Known serious illness or concomitant non-oncological disease.
  19. Patients unable to comply with the protocol.
  20. Patients with preserved reproductive capacity who are sexually active and unwilling to use a medically acceptable method of contraception.
  21. Pregnancy or breast feeding.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01314105
1199.119, 2010-022523-30
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

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