Reference Detail

Ref Type

Journal Article

PMID

(32398945)

Authors

Baird K, Glod J, Steinberg SM, Reinke D, Pressey JG, Mascarenhas L, Federman N, Marina N, Chawla S, Lagmay JP, Goldberg J, Milhem M, Loeb DM, Butrynski JE, Turpin B, Staddon A, Spunt SL, Jones RL, Rodler ET, Schuetze SM, Okuno SH, Helman L

Title

Results of a Randomized, Double-Blinded, Placebo-Controlled, Phase 2.5 Study of Saracatinib (AZD0530), in Patients with Recurrent Osteosarcoma Localized to the Lung.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Sarcoma	2020		2020	7935475	Sarcoma

URL

Abstract Text

Osteosarcoma is a rare cancer and a third of patients who have completed primary treatment will develop osteosarcoma recurrence. The Src pathway has been implicated in the metastatic behavior of osteosarcoma; about 95% of samples examined express Src or have evidence of downstream activation of this pathway. Saracatinib (AZD0530) is a potent and selective Src kinase inhibitor that was evaluated in adults in Phase 1 studies. The primary goal of this study was to determine if treatment with saracatinib could increase progression-free survival (PFS) for patients who have undergone complete resection of osteosarcoma lung metastases in a double-blinded, placebo-controlled trial. Patients and Methods. Subjects with recurrent osteosarcoma localized to lung and who had complete surgical removal of all lung nodules were randomized within six weeks after complete surgical resection. Saracatinib, or placebo, was administered at a dose of 175 mg orally, once daily, for up to thirteen 28-day cycles.Thirty-seven subjects were included in the analyses; 18 subjects were randomized to receive saracatinib and 19 to receive placebo. Intent-to-treat analysis demonstrated a median PFS of 19.4 months in the saracatinib treatment group and 8.6 months in the placebo treatment group (p=0.47). Median OS was not reached in either arm.Although saracatinib was well tolerated in this patient population, there was no apparent impact of the drug in this double-blinded, placebo-controlled trial on OS, and Src inhibition alone may not be sufficient to suppress metastatic progression in osteosarcoma. There is a suggestion of potential clinical benefit as evidenced by longer PFS in patients randomized to saracatinib based on limited numbers of patients treated.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials
Saracatinib	Saracatinib	3	1

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Saracatinib		AZD0530	BCR-ABL Inhibitor 31 SRC Inhibitor 31	Saracatinib (AZD0530) is a multi-kinase inhibitor with activity against ABL and SRC, which may block proliferation, metastasis, and survival in cancer cells (PMID: 19393585, PMID: 32398945).

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References