Overview

This trial is active, not recruiting.

Conditions ovarian neoplasms, peritoneal neoplasms
Treatments bibf 1120 + pld 30 mg/m2 + cbdca auc5 mg/ml*min, bibf 1120+ pld 30 mg/m2 + cbdca auc5 mg/ml*min
Phase phase 1
Sponsor Boehringer Ingelheim
Start date March 2011
End date July 2013
Trial size 19 participants
Trial identifier NCT01314105, 1199.119, 2010-022523-30

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BIBF 1120 (100 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) + PLD (30 mg/m2)
bibf 1120 + pld 30 mg/m2 + cbdca auc5 mg/ml*min
BIBF1120 twice daily along with standard therapy of PLD + carboplatin
(Experimental)
BIBF 1120 (150 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) + PLD (30 mg/m2)
bibf 1120 + pld 30 mg/m2 + cbdca auc5 mg/ml*min
BIBF1120 twice daily along with standard therapy of PLD + carboplatin
(Experimental)
BIBF 1120 (200 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) + PLD (30 mg/m2)
bibf 1120+ pld 30 mg/m2 + cbdca auc5 mg/ml*min
BIBF1120 twice daily along with standard therapy of PLD + carboplatin

Primary Outcomes

Measure
Maximum Tolerated Dose of Nintedanib Based on the Occurrence of DLTs During Treatment Course 1
time frame: 28 days

Secondary Outcomes

Measure
Area Under the Curve of PLD
time frame: 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration
The Maximum Measured Plasma Concentration of PLD
time frame: 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 25h, 27h, 30h, 34h, 48h, 168h, 336h and 480h after drug administration
Area Under the Curve of Carboplatin
time frame: 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, 34h, 48h, 168h, 336h and 480h after drug administration
The Maximum Measured Plasma Concentration of Carboplatin
time frame: 5 minutes (min) before drug administration and 30 min,59 min, 1 hour (h) 15 min, 1h 29min, 1h 45min, 2h 15min, 2h 45min, 4h, 6h, 7h 30min, 9h, 23h 55min, 25h, 26h, 27h, 28h, 30h, 32h, 34h, 48h, 168h, 336h and 480h after drug administration
Area Under the Curve of Nintedanib
time frame: 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration
The Maximum Measured Plasma Concentration of Nintedanib
time frame: 5 minutes (min) before drug administration and 1 hour (h) 2h, 3h, 4h, 6h, 8h, 10h, 24h, 144h, 312h and 456h after drug administration
Frequency of All Adverse Events Graded by CTCAE (Common Terminology Criteria for Adverse Events) Version 3.0
time frame: From the first drug administration until 28 days after the last drug administration, up to 50 months
Change From Baseline in Safety Laboratory Parameters
time frame: From the first drug administration until 28 days after the last drug administration, up to 50 months

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.