Assessing BAY86-9766 Plus Sorafenib for the Treatment of Liver Cancer. (BASIL)
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01204177
First received: September 16, 2010
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
This study investigates the safety and efficacy of the combination therapy with BAY86-9766 and sorafenib in patients with liver cancer. Safety will be determined by laboratory and other evaluations. Efficacy of the combination BAY86-9766 and sorafenib will be determined by disease control rate, overall survival, time to progression, response rate and duration of response.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: BAY86-9766 MEK Inhibitor + Sorafenib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of BAY86-9766 Plus Sorafenib as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC) |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Disease Control Rate (DCR) [ Time Frame: From first dose of combination treatment until last tumor evaluation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival (OS) [ Time Frame: 1st dose of study medication to last date of follow up ] [ Designated as safety issue: No ]
- Time To Progression (TTP) [ Time Frame: 1st dose of study medication until disease progression ] [ Designated as safety issue: No ]
- Response Rate (RR) [ Time Frame: 1st dose of study medication until last tumor evaluation ] [ Designated as safety issue: No ]
- Duration Of Response (DOR) [ Time Frame: 1st dose of study medication until last tumor evaluation ] [ Designated as safety issue: No ]
- Safety: physical examination, vital signs, adverse events, safety lab [ Time Frame: At day 1, 8, 15 of cycle 1 and 2 and day 1 of each next cycle until 30 days after EOT ] [ Designated as safety issue: Yes ]
- Patients reported hepatobiliary cancer symptoms and Health Related Quality of Life (HRQoL) [ Time Frame: At day 1 of each cycle and within 7 day after the last treatment ] [ Designated as safety issue: No ]
- Pharmacokinetic (PK) profiles of BAY86-9766 and sorafenib to evaluate drug exposure (not in all patients) [ Time Frame: Day -3, cycle 2 (day 1) ] [ Designated as safety issue: No ]
- Biomarkers [ Time Frame: At screening, day 1 of cycle 1 - 4, EOT ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | January 2014 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: BAY86-9766 MEK Inhibitor + Sorafenib
All patients who meet the entry criteria will receive BAY86-9766 50mg (2x20mg + 1x10mg capsules) twice daily in combination with sorafenib 800 mg (2x200 mg tablets bid). During the first 3 weeks they will receive a reduced dose of sorafenib: 600 mg / daily (1x200mg tablet in the morning + 2x200mg tablets in the evening) daily. This dose will be increased to the standard dose of 800 mg (400 mg bid) if no major side effects occur. Treatment until PD or until one of the withdrawal criteria for this study is met as described in the protocol (e.g. radiological progression or clinical progression)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or Female age >/= 18 years of age
- Life expectancy >/= 12 weeks
- Histologically or cytologically confirmed diagnosis of HCC, unresectable advanced or metastatic
- Liver function status of Child-Pugh class A. Child-Pugh status based on clinical findings and laboratory results during the screening period
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Patients must have at least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Previous or concurrent cancer other than HCC, except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder tumors.
- History of cardiac disease: Congestive heart failure (CHF), unstable angina, arrhythmias, Uncontrolled hypertension
- Clinically significant GI bleeding (CTCAE grade 3 or higher) within 30 days
- Renal failure requiring hemo- or peritoneal dialysis
- Known human immunodeficiency virus (HIV) infection
- Known history or symptomatic metastatic brain or meningeal tumors
- History of organ allograft.
- History of interstitial lung disease (ILD).
Excluded previous therapies and medications:
- Prior use of systemic anti-cancer treatment for HCC including cytotoxic chemotherapy, targeted agents, or any experimental therapy
- Radiotherapy within 4 weeks prior to start of study treatment
- Any other investigational agents within 4 weeks from the first dose of study treatment
- Major surgery within 4 weeks of start of study
- Concomitant use of strong inhibitors and strong inducers of CYP3A4
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204177
Locations
| Hong Kong | |
| Shatin, New Territories, Hong Kong | |
| Hong Kong, Hong Kong | |
| Korea, Republic of | |
| Jung-gu, Daegu Gwang''yeogsi, Korea, Republic of, 700-721 | |
| Goyang-si, Gyeonggido, Korea, Republic of, 410-769 | |
| Busan, Korea, Republic of, 602-739 | |
| Seoul, Korea, Republic of, 138-736 | |
| Seoul, Korea, Republic of, 110-744 | |
| Seoul, Korea, Republic of, 135-710 | |
| Seoul, Korea, Republic of, 120-752 | |
| Singapore | |
| Singapore, Singapore, 258499 | |
| Singapore, Singapore, 228510 | |
| Taiwan | |
| Kaohsiung, Taiwan, 833 | |
| Tainan, Taiwan, 736 | |
| Tainan, Taiwan | |
| Taipei, Taiwan, 100 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01204177 History of Changes |
| Other Study ID Numbers: | 14899 |
| Study First Received: | September 16, 2010 |
| Last Updated: | May 10, 2013 |
| Health Authority: | Korea: Food and Drug Administration Taiwan: Department of Health Singapore: Ministry of Health Hong Kong: Department of Health |
Keywords provided by Bayer:
|
Hepatocellular carcinoma (HCC) MEK inhibitor Sorafenib Disease control rate (DCR) Safety |
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 21, 2013