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.
1 other identifier
interventional
2
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
November 27, 2014
CompletedNovember 27, 2014
November 1, 2014
1.5 years
April 1, 2011
November 14, 2014
November 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib
to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.
28 days
Secondary Outcomes (7)
Maximum Measured Plasma Concentration (Cmax)
0.5h after the start of the infusion up to 56 days
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)
0.5h after the start of the infusion up to 56 days
Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)
0.5h after the start of the infusion up to 56 days
Time From Dosing to the Maximum Plasma Concentration (Tmax)
0.5h after the start of the infusion up to 56 days
Terminal Half-life (t1/2)
0.5h after the start of the infusion up to 56 days
- +2 more secondary outcomes
Study Arms (3)
BIBF 1120 (low) + Carboplatin + PLD
EXPERIMENTALBIBF 1120 (low dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)
BIBF 1120 (medium) + Carboplatin + PLD
EXPERIMENTALBIBF 1120 (medium dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)
BIBF 1120 (high) + Carboplatin + PLD
EXPERIMENTALBIBF 1120 (high dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)
Interventions
BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
Eligibility Criteria
You may qualify if:
- 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
- Up to 3 lines of prior chemo therapy, with treatment free interval of \>6 months
- Platinum based chemotherapy in the immediately preceding line.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
- Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines
You may not qualify if:
- Prior chemotherapy with PLD, and any contraindication for therapy with carboplatin or PLD.
- More than 2 lines of prior therapies that contained angiogenesis inhibitor.
- Patients for whom surgery is planned, e.g. interval debulking surgery.
- History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
- Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy.
- Laboratory values indicating an increased risk for adverse events.
- Significant cardiovascular diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The trial was prematurely terminated because of worldwide disruption of pegylated liposomal doxorubicin (PLD) supplies.
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2011
First Posted
April 6, 2011
Study Start
April 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
November 27, 2014
Results First Posted
November 27, 2014
Record last verified: 2014-11