Clinical Trials Resource Center


July 18, 2016

CytRx issued results of a phase III trial of aldoxorubicin compared to investigator’s choice of therapy in patients with relapsed or refractory soft tissue sarcomas (STS). The randomized, controlled trial enrolled 433 patients at 79 sites in 15 countries. Patients with metastatic, locally advanced or unresectable soft tissue sarcomas who had either not responded to, or who had progressed following treatment with one or more systemic regimens of non-adjuvant chemotherapy, were randomized 1:1 to be treated with aldoxorubicin or the investigator’s choice of an approved chemotherapeutic regimen, including doxorubicin, ifosfamide, dacarbazine, pazopanib (Votrient) or gemcitabine plus docetaxel. The primary endpoint of the study was PFS. Secondary endpoints include overall survival, response rates and safety. The study did not show a significant difference between aldoxorubicin and investigator’s choice of therapy for PFS, with a median of 4.17 months and 4.04 months, respectively, for the study’s primary endpoint (hazard ratio: 0.91). However, the most immediate indications of therapeutic activity, objective response rate (ORR) and disease control rate (ORR + stable disease four months), showed a near doubling in the aldoxorubicin arm compared to investigator’s choice, including in patients who previously received treatment with doxorubicin. Disease control rate for aldoxorubicin was significantly greater than investigator’s choice therapy in the intent-to-treat population (p=0.048) as well as in patients who received prior doxorubicin (p=0.0415). Patients continue to be followed for overall survival (OS), a secondary endpoint of the trial.

July 13, 2015

Eisai reported results of a phase III trial of eribulin mesylate for advanced leiomyosarcoma (LMS) or adipocytic sarcoma (ADI). The study was a randomized, openlabel, multicenter trial of eribulin mesylate 1.4mg/m2 administered intravenously (IV) on days one and eight of a 21-day cycle v. dacarbazine IV on day one, every 21 days (dose range of 850mg/m2 to 1,200 mg/m2) to patients (n=452) with locally advanced or recurrent and/or metastatic LMS or ADI who had disease progression following two standard therapies, one of which must have been an anthracycline (unless contraindicated). Data demonstrated patients treated with eribulin (n=228) experienced a median overall survival of 13.5 months compared to 11.5 months for those treated with dacarbazine (n=224) (HR 0.768; 95% CI 0.618-0.954; p=0.017). The secondary endpoints included progression-free rate (PFR) at week 12 and progression-free survival (PFS). While there was a numerical difference in PFR at week 12 between the eribulin and dacarbazine arms (33% v. 29%), this was not statistically significant. Median PFS was 2.6 months in both arms. Most frequent treatment-emergent adverse events in the eribulin arm were neutropenia, fatigue, nausea, alopecia and constipation.

February 9, 2015

CytRx reported results of a phase IIb study of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas (STS). In this randomized, open-label, 123-subject, 31-center, phase IIb trial, subjects with advanced soft tissue sarcomas were randomized 2:1 to receive either 350mg/m2 of aldoxorubicin (83 subjects) or 75mg/m2 of doxorubicin (40 subjects) every three weeks for up to six cycles. Subjects were then followed every six weeks with CT scans to monitor tumor size. The OS results in 123 patients showed aldoxorubicin-treated patients demonstrated a 27% reduction in the risk of death compared to patients treated with doxorubicin (HR 0.73: 95% confidence interval 0.44-1.20), the current standard-of-care in this indication. In addition, aldoxorubicin-treated patients demonstrated a 41% likelihood of surviving more than two years, a two-fold increase, compared to a 20% probability for doxorubicin- treated patients. Median overall survival was 16 months (95% confidence interval 13.1-not reached) for aldoxorubicin-treated patients v. 14.4 months (95% confidence interval 8.7-20.9) for doxorubicin-treated patients (p=0.21). For treatment-naive patients, representing 90% of the patients in the clinical trial, median overall survival was 16 months (95% confidence interval 13.1-not reached) for aldoxorubicin-treated patients v. 14 months (95% confidence interval 8.7-20.1) for doxorubicin treated patients (p=0.14). Progression-free survival (PFS) results demonstrated treatment with aldoxorubicin increased median PFS approximately 79% to 8.4 months, compared to 4.7 months with doxorubicin, meeting the study’s primary endpoint (HR=0.419; p=0.0007). In blinded central radiology review, PFS results demonstrated treatment with aldoxorubicin increased median PFS approximately 104% to 5.7 months, compared to 2.8 months with doxorubicin, also meeting the study’s primary endpoint (HR=0.584; p=0.024).

January 24, 2011

ARIAD Pharmaceuticals and Merck released positive results from a phase III trial of ridaforolimus, for the treatment of soft-tissue or bone sarcomas. This randomized, placebo-controlled, double-blind study, SUCCEED (Sarcoma Multi-Center Clinical Eval. of the Efficacy of Ridaforolimus), enrolled 711 subjects with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. The subjects received placebo or oral ridaforolimus administered at 40 mg a day for five consecutive days, followed by two days off, until disease progression. The primary endpoint of improved progression-free survival (PFS) compared to placebo was reached. Based on the full analysis of 552 PFS events, determined by an independent review committee, there was a statistically significant (p≡0.0001) 28% reduction by ridaforolimus in the risk of progression compared to placebo. Ridaforolimus treatment resulted in a statistically significant 21% (3.1 week) improvement in median PFS (ridaforolimus, 17.7 weeks versus placebo, 14.6 weeks). Based on the full analysis determined by the investigative sites, there was a statistically significant (p<0.0001) 31% reduction in the risk of progression compared to placebo. Ridaforolimus resulted in a statistically significant 52% (7.7 week) improvement in median PFS (ridaforolimus, 22.4 weeks versus placebo, 14.7 weeks).

January 28, 2008

Threshold released results from a phase II trial of glufosfamide for the treatment of soft tissue sarcoma. This open label trial enrolled twenty two subjects with metastatic and/or advanced unresectable soft tissue sarcoma, previously treated with one or two prior systemic therapies, in the United States. The primary endpoint was objective response rate. Secondary endpoints included duration of response, progression-free survival, overall survival and safety. Tumor response was evaluated at baseline and every six weeks using the Response Evaluation Criteria In Solid Tumors (RECIST). Eight of eighteen (44%) evaluable subjects demonstrated a clinical benefit of stable disease or partial response. Renal failure and renal toxicities were the most common adverse events. Based on the results Threshold planned to evaluate different dosing regimens likely required to improve the therapeutic index.

September 20, 2004

GenVec has published positive results from a phase I study of TNFerade, their gene therapy for the treatment of soft tissue sarcomas of the extremities. The results, published in the September 1st edition of Clinical Cancer Research, found a regimen of TNFerade and radiation therapy produced no dose-limiting toxicities; mild flu-like symptoms, including chills, fever and fatigue, was the most common adverse event. Furthermore, of the 13 subjects who received the drug, 11 (85%) showed objective tumor response, including 9 partial responses and 2 complete. Furthermore, 10 of the 11 subjects who received the treatment prior to surgery achieved either a complete response or >50% tumor cell necrosis. The study enrolled a total of 14 evaluable subjects with soft-tissue sarcomas of the extremities, who received one of three regimens of TNFerade during weeks one and two of a two-to-five week course of standard radiation therapy. TNFerade is currently in phase II studies in the treatment of esophageal, pancreatic, and renal cancers.

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