Clinical trial NCT01329549: Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ovarian Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-04-06
Enrollment: 2
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib
timeFrame: 28 days
Secondary outcomes:
measure: Maximum Measured Plasma Concentration (Cmax)
timeFrame: 0.5h after the start of the infusion up to 56 days
measure: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)
timeFrame: 0.5h after the start of the infusion up to 56 days
measure: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)
timeFrame: 0.5h after the start of the infusion up to 56 days
measure: Time From Dosing to the Maximum Plasma Concentration (Tmax)
timeFrame: 0.5h after the start of the infusion up to 56 days
measure: Terminal Half-life (t1/2)
timeFrame: 0.5h after the start of the infusion up to 56 days
measure: Total Plasma Clearance (CL)
timeFrame: 0.5h after the start of the infusion up to 56 days
measure: Apparent Volume of Distribution at Steady State (Vss)
timeFrame: 0.5h after the start of the infusion up to 56 days
Other outcomes:
Locations:
city: Akashi, Hyogo
country: Japan
facility: 1199.117.003 Boehringer Ingelheim Investigational Site
city: Chuo-ku,Tokyo
country: Japan
facility: 1199.117.002 Boehringer Ingelheim Investigational Site
city: Hidaka, Saitama
country: Japan
facility: 1199.117.001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: