Clinical Trials Resource Center

New Medical Therapies™

Liver Cancer

September 24, 2012

Jennerex reported results from a phase II trial of JX-594 for the treatment of hepatocellular carcinoma (HCC). This nonrandomized study enrolled 25 Asian patients with advanced HCC; 20 were refractory to sorafenib and were treated with an intravenous dose of JX-594, while the majority of patients then received sequential intra-tumoral doses of JX-594 at week one and three. The majority subsequently received treatment with sorafenib. The study met its primary endpoint of determining the safety of JX-594 followed by sorafenib in patients with advanced HCC. After six or 12 weeks, 59% had disease control as measured by modified RECIST and 75% had objective responses by Choi criteria. 85% of patients had disease control by mRECIST or Choi response. The sequential treatment regimen was well tolerated with transient flu-like symptoms, with the most common adverse event being transient leukopenia. Jennerex is planning several phase II studies of JX-594 in liver cancer, HCC and colorectal cancer.

January 23, 2012

ArQule released initial results from a phase II trial of ARQ-197 for the treatment of hepatocellular carcinoma. This randomized, double-blind, placebo controlled trial enrolled 107 subjects with unresectable HCC who had failed one prior systemic therapy. The subjects initially received 360 milligrams twice daily or placebo. However, the dose was subsequently reduced to 240 milligrams twice daily following reports of neutropenia. Data showed a statistically significant 56% improvement in time-to-progression in the intent-to-treat population (p≡0.04). The subjects treated with ARQ-197 had a higher incidence of fatigue and hematologic events, including neutropenia and anemia. However, these declined following dose reduction of tivantinib.

May 16, 2011

Can-Fite Biopharma issued interim results from a phase I/II trial of CF-102 for hepatocellular carcinoma. This open label trial enrolled 18 subjects most of whom had failed prior treatment with sorafenib, the current standard of care. The subjects initially received 1 mg orally twice daily (BID), with subsequent escalations to 5 and 25 mg BID for 28-day cycles. The median overall survival time was 8.1 months and CF-102 had a positive safety profile.

April 11, 2011

Jennerex and Transgene reported results from combined phase I and II trials of JX-594 for the treatment of liver cancer. Data are from 35 subjects with either hepatocellular carcinoma or cancer metastases to the liver (including colorectal cancer, melanoma and renal cancer). All subjects received up to eight intratumoral injections of JX-594 therapy. Twenty-three subjects (66%) exhibited significant tumor necrosis and responses by modified Choi criteria (decreased tumor density). Seven subjects (20% of evaluable) also exhibited objective response by Response Evaluation Criteria in Solid Tumor (RECIST) criteria, including two complete responses upon long-term follow-up. Twenty subjects (57%) had stable disease as defined by RECIST criteria. The most common adverse events was transient flu-like symptoms.

September 25, 2006

AmpliMed released positive interim results from a phase I/II trial of Amplimexon in combination with the drug dacarbazine (DTIC) for the treatment of malignant melanoma. This trial enrolled 69 subjects with stage III and IV melanoma who had not received prior chemotherapy treatment. Subjects received Amplimexon intravenously for 30 minutes followed by an infusion of dacarbazine for 30 minutes, for five consecutive days every three weeks. The phase I portion of the study was designed to assess the safety of this combination treatment and to determine the maximum tolerated dose. The phase II portion was designed to determine the efficacy of the drug at the maximum tolerated dose. Results from phase I showed the combination to be safe and determined the MTD for phase II, with the most common adverse events mild in nature. At this time 32 out of a target 45 subjects had been enrolled in the phase II portion.

BioAlliance reported positive results from a phase I/II trial of doxorubicin Transdrug for the treatment of liver cancer. This trial enrolled 20 subjects who received at least one intra-arterial hepatic injection of doxorubicin Transdrug, at varied doses, in order to determine the maximum tolerated dose for future trials. Efficacy results from the subgroup receiving 30mg/m2 revealed this to be the most promising dose. Disease control was observed in 12 out of 20 (60%) of the subjects, with five partial responses and seven stabilizations. Phase II/III trials are expected to begin shortly.

SciClone and Sigma-Tau announced positive interim results from a phase II trial of Zadaxin for the treatment of stage IV malignant melanoma. Results are from 463 of the 485 enrolled subjects who received Zadaxane combined with standard dacarbazine chemotherapy (DTIC), with or without interferon alpha. Of the 99 subjects treated with 3.2 mg of Zadaxin/ DTIC combination treatment, 12.1% achieved an overall response versus a 5.3% response for the 95 patients in the control arm. Of the 97 subjects treated with 3.2 mg of Zadaxin/DTIC combination therapy and low-dose interferon alpha, 10.3% showed an overall response; and of the 97 subjects receiving 1.6 mg of Zadaxin/DTIC and low-dose interferon alpha, 7.2% showed an overall response. Final results are expected by the end of 2006 with phase III trials planned for early 2007.

June 27, 2005

Onyvax reported positive results from the second study cohort in a phase II trial of their investigational prostate cancer vaccine Onyvax-P. Results from the study yielded evidence of efficacy, with 42% of patients achieving statistically significant reduction in prostate specific antigen velocity, and an improvement in median time to disease progression to 58 weeks, vs. a historical baseline of 26-29 weeks. No significant toxicity was noted. This open-label study enrolled 13 patients with hormone-resistant prostate cancer (HRPC). Based on these results, the company announced plans to initiate phase IIb/III trials of the drug before the end of 2005.

pSivida has issued positive results of a phase IIa trial of BrachySil, their investigational brachytherapy for the treatment of liver cancer. Trial data met primary safety endpoints, with no serious adverse events noted and a positive overall tolerability profile. Secondary efficacy measures indicated that the drug was efficacious in inducing tumor regression in targeted lesions, including some 100% regressions. This open-label study enrolled 8 patients with inoperable liver tumors at the Singapore General Hospital, who received BrachySil implantations, with 3 and 6 month observational follow-ups. The company announced plans to initiate a multi-center, dose-escalating phase IIb trial of the drug in the second half of 2005.

October 4, 2004

Ariad Pharmaceuticals reported interim results of a pair of phase I single-agent study of AP23573, their mTOR inhibitor for the treatment of solid tumors. Trial results showed to drug to be efficacious in treating solid tumors, with 49% (24 of 49) of subjects demonstrating a tumor response; this included 9 partial responses (reduction of tumor size by at least 30%), 5 partial responses (reduction of tumor size by 15%-29%), and 14 disease stabilizations. Median response was 5 months, with some responses extending to 18 months. The drug was well tolerated in both trials, with oral mucositis observed as the dose limiting toxicity. The two trials have to date enrolled a total of 49 subjects with mixed solid tumors; 27 subjects in a daily-dosing investigation and 22 subjects on a weekly-dosing regimen. Both trials are ongoing.

Bayer Pharmaceuticals and Onyx Pharmaceuticals reported the results of a phase II single-agent study of BAY43-9006, their RAF kinase/VEGFR inhibitor being investigated for the treatment of advanced hepatocellular carcinoma (HCC), at the 16th meeting of the American Association for Cancer Research – National Cancer Institute – European Organization for Research and Treatment of Cancer in Geneva, Switzerland. Results of the trial indicated that the drug demonstrated significant efficacy, with 43% of subjects demonstrating 4-month stable disease state, 4% of subjects demonstrating a reduction in tumor size of 25% to 50%,and 5% of subjects demonstrating tumor shrinkage of 50% or more. Median survival rate for all subjects was 9.2 months, and median time to progression was 4.2 months. The open label study enrolled a total of 137 treatment-naïve patients with advanced HCC, all of whom received 400 mg. twice daily in continuous 4-week regimens. Based on this data, the companies announced plans to initiate a phase III single-agent trial, as well as a phase II chemotherapy adjuvant trial.

Epimmune Inc. announced positive combined results of two phase I trials of their multi-epitope cancer vaccine candidate EP-2101, for the treatment of non-small cell lung cancer (NSCLC) and colorectal cancer. Preliminary efficacy data have indicated that the vaccine is strongly immunogenic, with 93% of subjects demonstrating immunological response to at least 1 of the 9 antigenic vaccine components, 53% of subjects demonstrating response to 5 of the 9, and a median response to 4 of the 9. The vaccine was safe and well tolerated. The trials enrolled a total of 24 subjects with stage IIB/IIIA NSCLC or stage III colorectal cancer, all of whom received a total of 6 treatments with the vaccine, once every three weeks for 18 weeks. Following the results of these two investigations, Epimmune announced plans for the initiation of a phase II trial in NSCLC, to be initiated by the end of 2005.

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