Phase 2
N=37
An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
Liver Neoplasms · Unresectable Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00247676 ↗Enrolled (actual)
37
Serious AEs
64.9%
Results posted
Feb 2010
Primary outcome: Primary: Best Overall Response — 0; 1; 15; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sunitinib (SU011248) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response |
0; 1; 15; 11; 7; 3 | — |
| PRIMARY Objective Response (CR or PR) |
1 | — |
| SECONDARY Duration of Objective Response (CR or PR) |
32.4 | — |
| SECONDARY Clinical Benefit Response (CR, PR, or SD With Duration ≥12 Weeks) |
14 | — |
| SECONDARY Best Overall Response of PR or SD With Duration ≥12 Weeks |
14 | — |
| SECONDARY Progression-Free Survival (Overall ITT) |
16.1 | — |
| SECONDARY Progression-Free Survival (ITT Child Pugh Class A Subject Population) |
21.0 | — |
| SECONDARY Time to Tumor Progression (Overall ITT) |
23.00 | — |
| SECONDARY Time to Tumor Progression (ITT Child Pugh Class A Subject Population) |
23.00 | — |
| SECONDARY Overall Survival (Overall ITT) |
34.6 | — |
| SECONDARY Overall Survival (ITT Child Pugh Class A Subject Population) |
40.4 | — |
| SECONDARY 1-Year Survival Probability |
0.324 | — |
| SECONDARY Trough Plasma Concentrations (Ctrough) of Sunitinib |
0.00; 75.05; 64.19; 3.27; 47.68; 1.11 | — |
| SECONDARY Ctrough of SU-012662 (Metabolite of Sunitinib) |
0.00; 20.49; 20.77; 2.29; 18.04; 1.14 | — |
| SECONDARY Ctrough of Total Drug (Sunitinib + SU-012662) |
95.54; 87.99; 9.92; 65.73; 4.49; 61.41 | — |
| SECONDARY Dose-Corrected Ctrough of Sunitinib |
0.00; 78.52; 78.20; 6.55; 62.88; 3.01 | — |
| SECONDARY Dose-Corrected Ctrough of SU-012662 (Metabolite of Sunitinib) |
0.00; 21.07; 24.20; 3.63; 22.86; 2.71 | — |
| SECONDARY Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) |
99.59; 102.40; 8.89; 85.75; 4.63; 88.50 | — |
| SECONDARY Circulating Endothelial Cells (CECs) and Circulating Endothelial Progenitor Cells (CEPs) |
— | — |
| SECONDARY Tissue Tumor Markers Assessed by Tumor Biopsy |
— | — |
| SECONDARY Plasma Concentration of Vascular Endothelial Growth Factor (VEGF) |
54.9; 210.7; 182.9; 81.3; 234.7; 157.8 | — |
| SECONDARY Plasma Concentration of VEGF-C |
822.2; 731.7; 693.1; 733.8; 601.6; 802.7 | — |
| SECONDARY Plasma Concentration of Soluble VEGF Receptor-2 (sVEGFR-2) |
7068.5; 3824.5; 3105.8; 6121.5; 3542; 4408.5 | — |
| SECONDARY Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3) |
48700; 25300; 11075; 44100; 11450; 12430 | — |
| SECONDARY Plasma Concentration of Soluble KIT (sKIT) |
41960; 32680; 22910; 21615; 18125; 18420 | — |
Summary
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00247676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.