| Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma |
| A Multicenter, Global, Randomized, Double-blind Study Of Axitinib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced Hepatocellular Carcinoma Following Failure Of One Prior Antiangiogenic Therapy |
| The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Hepatocellular Carcinoma |
- Drug: Axitinib (AG-013736)
Axitinib [tablet, 1 mg, 5 mg] will be given twice daily [BID] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID
- Other: Best Supportive Care
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
- Drug: Placebo
Placebo [tablet, 1 mg, 5 mg] will be given twice daily [BID] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID
|
- Experimental: A
Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration
Interventions:
- Drug: Axitinib (AG-013736)
- Other: Best Supportive Care
- Placebo Comparator: B
Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study
Interventions:
- Drug: Placebo
- Other: Best Supportive Care
|
| Kang YK, Yau T, Park JW, Lim HY, Lee TY, Obi S, Chan SL, Qin S, Kim RD, Casey M, Chen C, Bhattacharyya H, Williams JA, Valota O, Chakrabarti D, Kudo M. Randomized phase II study of axitinib versus placebo plus best supportive care in second-line treatment of advanced hepatocellular carcinoma. Ann Oncol. 2015 Dec;26(12):2457-63. doi: 10.1093/annonc/mdv388. Epub 2015 Sep 18. |
| |
| Completed |
| 225 |
| December 2016 |
| March 2014 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Locally advanced or metastatic HCC
- Failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and brivanib.
- Child-Pugh Class A or B (score 7 only) disease.
Exclusion Criteria:
- Prior treatment of advanced HCC with more than one prior first-line systemic therapy.
- Any prior local therapy within 2 weeks of starting the study treatment.
- Presence of hepatic encephalopathy and/or clinically relevant ascites.
- Presence of main portal vein invasion by HCC.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, China, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Slovakia, Taiwan, United Kingdom, United States |
| Singapore |
| |
| NCT01210495 |
A4061058
2010-021590-37 ( EudraCT Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| February 2017 |
