October 2012: Trials in Progress

Published: Thursday, Oct 18, 2012
This phase III study will compare denosumab versus placebo as adjuvant treatment for women with stage II or III breast cancer who are at high risk of disease recurrence, and whose hormone and HER2 receptor status is known. Study participants must be scheduled for standard-of-care adjuvant or neoadjuvant chemotherapy, endocrine, or HER2 targeted therapy to be administered alone or in combination. Patients will be randomized to receive 120 mg of denosumab or placebo subcutaneously monthly for 6 months, and then every 3 months, for a total of 5 years of treatment, along with vitamin D and calcium supplementation. The primary endpoint of the study is bone metastasis–free survival. Secondary endpoints include OS and distant recurrence–free survival. Investigators will also examine disease-free survival, as well as safety and tolerability.

Sponsor: Amgen, Daiichi Sankyo

ClinicalTrials.gov Identifier: NCT01077154


Aromatase inhibitor combined with lapatinib or trastuzumab or both for metastatic breast cancer

This phase III study will randomize postmenopausal women with metastatic breast cancer to one of three treatment arms as first-line therapy: lapatinib plus trastuzumab plus an aromatase inhibitor (AI); trastuzumab plus an AI; or lapatinib plus an AI. Study participants must have HER2+/HR+ metastatic breast cancer and have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting, but must be ineligible for chemotherapy. The AI can be letrozole, anastrozole, or exemestane, with the choice of treatment made by the investigator. The primary efficacy endpoint is OS for lapatinib/ trastuzumab/AI versus trastuzumab/AI. Secondary efficacy measures include a comparison of OS between trastuzumab/ AI and lapatinib/AI, as well as between trastuzumab/ lapatinib/AI and lapatinib/AI; comparisons of PFS, overall response rate (ORR); time to response; duration of response; and safety and tolerability for all three treatment groups.

Sponsor: GlaxoSmithKline

ClinicalTrials.gov Identifier: NCT01160211


Prostate Cancer

Orteronel for advanced prostate cancer

This phase III study will compare the investigational agent orteronel (TAK-700) plus prednisone versus placebo plus prednisone in patients with mCRPC that has progressed during or following docetaxel-based therapy. Orteronel is a selective inhibitor of 17,20-lyase, a key enzyme in the testosterone synthesis pathway. In order to be eligible, patients must have evidence of disease progression during or after receiving a total of 360 mg/m2 docetaxel or more within a 6-month period. Patients who cannot tolerate docetaxel or who have progressive disease before receiving 360 mg/m2 or more are also eligible if they have received at least 225 mg/m2 of docetaxel within a 6-month period and satisfy the other inclusion criteria, which include radiographically documented metastatic disease and baseline testosterone level lower than 50 ng/dL following surgical or medical castration. The primary endpoint is OS. Secondary endpoints include radiographic PFS, PSA decrease of ≥50% at 12 weeks, pain response at 12 weeks, safety, time to PSA progression, ORR by RECIST, circulating tumor cell and endocrine marker changes, and patient-reported outcomes. Tumor specimens will be analyzed for biomarkers that may predict orteronel antitumor activity.

Sponsor: Millennium Pharmaceuticals

ClinicalTrials.gov Identifier: NCT01193257


Sarcoma

Trabectedin- or doxorubicin-based chemotherapy for translocation-related sarcoma

This phase III study will compare trabectedin versus standard doxorubicin-based chemotherapy as first-line treatment in patients with advanced translocation-related sarcoma (TRS). Trabectedin is the first of a new class of antitumor agents with a transcription-targeted mechanism of action. Patients with confirmed TRS of several subtypes, including myxoid/round-cell liposarcoma, alveolar soft-part sarcoma, angiomatoid fibrous histiocytoma, clear-cell sarcoma, desmoplastic small round-cell tumor, low-grade endometrial stromal sarcoma, low-grade fibromyxoid sarcoma, myxoid chondrosarcoma, and synovial sarcoma, are stratified by performance status and sarcoma subtype and randomized to trabectedin or doxorubicin with or without ifosfamide. Confirmation of the translocation by fluorescence in situ hybridization is required for inclusion in the primary efficacy analysis. The primary outcome measure is PFS. Secondary outcome measures include best objective response, OS, duration of response, and incidence of adverse events.

Sponsor: Johnson & Johnson

ClinicalTrials.gov Identifier: NCT00796120



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