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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 Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01329549
First received: April 1, 2011
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Ovarian Neoplasms
 Drug: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Drug: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Drug: BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIBF 1120 (low) + Carboplatin + PLD
BIBF 1120 (low dose) + carboplatin (AUC5 mg/mL*min) + PLD (30 mg/m2)
 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 (medium) + Carboplatin + PLD
BIBF 1120 (medium dose) + carboplatin (AUC5 mg/mL*min) + PLD (30 mg/m2)
 Drug: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
BIBF 1120 towice daily along with standard therapy of PLD + CBDCA
Experimental: BIBF 1120 (high) + Carboplatin + PLD
BIBF 1120 (high dose) + carboplatin (AUC5 mg/mL*min) + PLD (30 mg/m2)
 Drug: BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
BIBF 1120 towice daily along with standard therapy of PLD + CBDCA

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329549

Locations
Japan
1199.117.003 Boehringer Ingelheim Investigational Site
Akashi, Hyogo, Japan
1199.117.002 Boehringer Ingelheim Investigational Site
Chuo-ku,Tokyo, Japan
1199.117.001 Boehringer Ingelheim Investigational Site
Hidaka, Saitama, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01329549     History of Changes
Other Study ID Numbers: 1199.117
Study First Received: April 1, 2011
Last Updated: April 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
 Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Doxorubicin
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013