An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00247676
First received: November 1, 2005
Last updated: February 4, 2010
Last verified: February 2010
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Purpose
The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Neoplasms Unresectable Hepatocellular Carcinoma |
Drug: Sunitinib (SU011248) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Best Overall Response [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
- Objective Response (CR or PR) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of Objective Response (CR or PR) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death due to cancer ] [ Designated as safety issue: No ]
- Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks on study ] [ Designated as safety issue: No ]
- Best Overall Response of PR or SD With Duration ≥12 Weeks [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or SD with duration of at least 12 weeks or death due to cancer ] [ Designated as safety issue: No ]
- Progression-Free Survival (Overall ITT) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ] [ Designated as safety issue: No ]
- Progression-Free Survival (ITT Child Pugh Class A Subject Population) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ] [ Designated as safety issue: No ]
- Time to Tumor Progression (Overall ITT) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
- Time to Tumor Progression (ITT Child Pugh Class A Subject Population) [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ] [ Designated as safety issue: No ]
- Overall Survival (Overall ITT) [ Time Frame: From start of study treatment until death. ] [ Designated as safety issue: No ]
- Overall Survival (ITT Child Pugh Class A Subject Population) [ Time Frame: From start of study treatment until death. ] [ Designated as safety issue: No ]
- 1-Year Survival Probability [ Time Frame: From start of treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter up until 1 year. ] [ Designated as safety issue: No ]
- Trough Plasma Concentrations (Ctrough) of Sunitinib [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Ctrough of SU-012662 (Metabolite of Sunitinib) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Ctrough of Total Drug (Sunitinib + SU-012662) [ Time Frame: Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Dose-Corrected Ctrough of Sunitinib [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) [ Time Frame: Cycle 1 (Days 14, 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs) [ Time Frame: Cycle 1 (Days 1, 14), Cycle 2 (Days 1, 28), Cycle 5 (Day 1) ] [ Designated as safety issue: No ]
- Tissue Tumor Markers Assessed by Tumor Biopsy [ Time Frame: Day 28 of Cycle 1 (optional) ] [ Designated as safety issue: No ]
- Plasma Concentration of Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Plasma Concentration of VEGF-C [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
- Plasma Concentration of Soluble KIT (sKIT) [ Time Frame: Cycle 1 (Days 1, 14, 28), Cycle 2 (Days 1, 28), Cycle 5 (Day 28) ] [ Designated as safety issue: No ]
| Enrollment: | 37 |
| Study Start Date: | February 2006 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Sunitinib (SU011248)
Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
Other Name: SU011248, Sutent
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of hepatocellular carcinoma
- Patients must present with disease not amenable to curative surgery (i.e. either hepatectomy, or liver transplant).
- Evidence of measurable disease by radiographic technique
- Adequate organ function.
Exclusion Criteria:
- Prior treatment with any systemic treatment for liver cancer
- Presence of clinically relevant ascites
- Severe hemorrhage <4 weeks of starting study treatment.
- Diagnosis of second malignancy within last 3 years
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- Known human immunodeficiency virus (HIV)
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247676
Locations
| France | |
| Pfizer Investigational Site | |
| Clichy Cedex, France, 92118 | |
| Pfizer Investigational Site | |
| Rennes Cedex, France, 4422935062 | |
| Pfizer Investigational Site | |
| Saint Herrblain Cedex, France, 44805 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 135-710 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 138-736 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 152-703 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Taipei, Taiwan, 110 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00247676 History of Changes |
| Other Study ID Numbers: | A6181055 |
| Study First Received: | November 1, 2005 |
| Results First Received: | January 6, 2010 |
| Last Updated: | February 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Liver neoplasms, sunitinib, Phase 2 |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Adenocarcinoma Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013