A Phase II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00987935
First received: September 30, 2009
Last updated: May 15, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: Sorafenib Drug: BIBF 1120 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open Label, Phase I/Randomized II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Sorafenib for Advanced Hepatocellular Carcinoma Patients in Asia. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Maximum tolerated dose in phase I [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Time to progression in phase II [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse event [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
- incidence of dose limiting toxicity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Pharmacokinetic parameters [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Response [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: about 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 142 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BIBF 1120
Phase I dose escalation and phase II using dose determined in phase I
|
Drug: BIBF 1120
Twice daily
|
|
Active Comparator: Sorafenib
Twice daily dosing in phase II
|
Drug: Sorafenib
400 mg twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed, which is not amenable to curative surgery or loco-regional therapy
- Age 18 years or older
- Eastern Cooperative Group performance score of 2 or less
- Child-Pugh score of 7 or less
- Written informed consent in accordance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) and local legislation
Exclusion criteria:
- Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase II)
- More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase I)
- Uncontrolled or refractory ascites to adequate medical therapy
- Bilirubin greater than 1.5 times upper limit of normal
- Aspartate amino transferase or alanine amino transferase greater than 5 times upper limit of normal
- Absolute neutrophil count less than 1500/microliter
- Platelet count less than 75000/microliter
- Hemoglobin less than 9 g/dL
- Serum creatinine greater than 1.5 times upper limit of normal
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987935
Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Locations
| Korea, Republic of | |
| 1199.39.82001 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Seoul, Korea, Republic of | |
| 1199.39.82002 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Seoul, Korea, Republic of | |
| 1199.39.82003 Boehringer Ingelheim Investigational Site | Completed |
| Seoul, Korea, Republic of | |
| 1199.39.82004 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Seoul, Korea, Republic of | |
| 1199.39.82005 Boehringer Ingelheim Investigational Site | Completed |
| Seoul, Korea, Republic of | |
| 1199.39.82006 Boehringer Ingelheim Investigational Site | Completed |
| Seoul, Korea, Republic of | |
| Taiwan | |
| 1199.39.88606 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Changhua, Taiwan | |
| 1199.39.88610 Boehringer Ingelheim Investigational Site | Completed |
| Kaohsiung, Taiwan | |
| 1199.39.88609 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Kaohsiung, Taiwan | |
| 1199.39.88605 Boehringer Ingelheim Investigational Site | Completed |
| Taichung, Taiwan | |
| 1199.39.88602 Boehringer Ingelheim Investigational Site | Recruiting |
| Tainan, Taiwan | |
| 1199.39.88608 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Tainan City, Taiwan | |
| 1199.39.88601 Boehringer Ingelheim Investigational Site | Recruiting |
| Taipei, Taiwan | |
| 1199.39.88603 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Taipei, Taiwan | |
| 1199.39.88604 Boehringer Ingelheim Investigational Site | Active, not recruiting |
| Taoyuan County, Taiwan | |
| 1199.39.88607 Boehringer Ingelheim Investigational Site | Completed |
| Yunlin County, Taiwan | |
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: | NCT00987935 History of Changes |
| Other Study ID Numbers: | 1199.39 |
| Study First Received: | September 30, 2009 |
| Last Updated: | May 15, 2013 |
| Health Authority: | South Korea: Ministry of Food and Drug Safety (MFDS) Taiwan: Department of Health United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Liver Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013