Fruzaqla (fruquintinib)

P3 | "Clinical Trial Registration Number: NCT02314819, NCT04322539"

P4, N=51, Active, not recruiting, Zhongnan Hospital | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jan 2024 --> Jan 2025

P2, N=141, Recruiting, Shandong Cancer Hospital and Institute

"BACKGROUND: Systemic therapies such as fruquintinib, regorafenib, and trifluridine/tipiracil (T/T) have demon- strated survival benefits vs best supportive care (BSC) in patients with metastatic colorectal cancer (mCRC) pre- viously treated with oxaliplatin- and irinotecan-based chemotherapy (OIC)...OBJECTIVE: To compare the AE management costs of fruquin- tinib, regorafenib, T/T and T/T+bevacizumab (T/T+bev) for mCRC previously treated with OIC, from US Commercial and Medicare payer perspectives... Based on the cost-consequence model results, fruquintinib was associated with lower AE manage- ment costs compared with regorafenib, T/T, and T/T+bev for patients with mCRC previously treated with OIC, which should be considered in treatment and formulary decision- making."

P1, N=30, Recruiting, Wuhan Union Hospital, China

Fruquintinib, a tyrosine kinase inhibitor, has been shown to be effective in heavily pretreated mCRC progressing to trifluridine-tipiracil (FTD/TPI) or regorafenib or both...These results led to FDA approval of fruquintinib for pretreated mCRC patients who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy...However, an optimal sequence of treatments is yet to be defined. In this review, we propose an algorithm for later lines of treatment to integrate fruquintinib as a standard of care together with the new therapeutic combinations that recently showed clinical benefit for chemorefractory mCRC, in both molecularly selected (e.g. KRASG12C or HER2 amplification) and in non-oncogenic driven patients.

P1/2, N=381, Recruiting, Hutchmed | Trial completion date: Sep 2023 --> Dec 2025 | Trial primary completion date: Sep 2023 --> Dec 2025

P2, N=84, Completed, BeiGene | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Feb 2024

P=N/A, N=36, Recruiting, Peking University First Hospital

P3, N=120, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting

Both fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab combined with 5-fluorouracil, l-leucovorin, and irinotecan (FOLFIRI) proved ineffective against the disease...The patient was initially treated with ensartinib monotherapy for 9 months, then with ensartinib combined with local radiotherapy and fruquintinib for another 4 months for isolated hilar hepatic lymph node metastasis. The patient experienced disease progression with an acquired ALK G1202R resistance mutation that responded well to lorlatinib...However, the patient responded remarkably well to alectinib. Our report emphasizes the importance of gene detection in the treatment of malignant tumors, and the significance of ALK mutations in CRC.

P2, N=45, Recruiting, Wuhan Union Hospital, China

Moreover, a possible connection between the induction potential on cytochrome P450 isoenzymes (CYP1A2 and CYP3A4) and passive transport of a given drug into the central nervous system via BBB was investigated. Current clinical experience and future directions regarding of fruquintinib (1) were also briefly outlined.

P1/2, N=112, Active, not recruiting, Hutchison Medipharma Limited | Recruiting --> Active, not recruiting

P=N/A, N=47, Recruiting, Peking University | Not yet recruiting --> Recruiting

P=N/A, N=20, Recruiting, Fudan University

P2, N=39, Active, not recruiting, Fudan University | Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Feb 2024

Six drugs (abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib, upadacitinib) are used for the treatment of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis)...The following seven drugs received FDA approval in 2023: capivasertib (HER2-positive breast cancer), fruquintinib (metastatic colorectal cancer), momelotinib (myelofibrosis), pirtobrutinib (mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma), quizartinib (Flt3-mutant acute myelogenous leukemia), repotrectinib (ROS1-positive lung cancer), and ritlecitinib (alopecia areata). All of the FDA-approved drugs are orally effective with the exception of netarsudil, temsirolimus, and trilaciclib. This review summarizes the physicochemical properties of all 80 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, polar surface area, potency, solubility, lipophilic efficiency, and ligand efficiency.

P=N/A, N=124, Completed, Peking University People's Hospital

P=N/A, N=47, Not yet recruiting, Peking University

Our results suggest that TAS-102 combined with fruquintinib has promising clinical efficacy and manageable safety for refractory mCRC patients in a real-world clinical setting. Further prospective trials are warranted to confirm our results.

P=N/A, N=520, Completed, Fudan University

P1/2, N=46, Recruiting, Chinese PLA General Hospital | Not yet recruiting --> Recruiting | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P=N/A, N=0, Available, Takeda

P1/2, N=220, Not yet recruiting, Zhejiang Cancer Hospital

P4, N=51, Active, not recruiting, Zhongnan Hospital | N=12 --> 51

P2, N=84, Active, not recruiting, BeiGene | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2023 --> Feb 2024

P2, N=40, Recruiting, Huazhong University of Science and Technology

Multivariate Cox regression showed that the adjusted HR was 0.49 (95% CI: 0.26-0.93), which was adjusted with sex, age greater than 65 yr, ECOG-PS, RAS mutation, BRAF mutation, location of lesion (left or right), surgery history, metastases (liver and lung), prior medication (bevacizumab and cetuximab), and current line (3 or later). Pts in FP cohort showed a significantly greater PFS than those in FM cohort. And with further analysis, FP indicated robustly lower HRs than FM. Our study suggests FP could provide additional benefits to pts with MSS/pMMR mCRC, and warrants further investigations in a large cohort.

P=N/A, N=58, Recruiting, Fudan University

P4, N=51, Recruiting, Henan Cancer Hospital; Henan Cancer Hospital

P2, N=43, Recruiting, Xiaofeng Chen | Not yet recruiting --> Recruiting

P2, N=30, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

P4, N=30, Recruiting, The First Affiliated Hospital of Nanchang University

P1/2, N=56, Not yet recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

P2, N=30, Recruiting, Tianjin Medical University Cancer Institute and Hospital

P2, N=30, Recruiting, Tianjin Medical University Cancer Institute and Hospital

P2, N=30, Recruiting, Tianjin Medical University Cancer Institute and Hospital

P=N/A, N=36, Recruiting, Wuhan Union Hospital, China

P2, N=45, Not yet recruiting, Second Affiliated Hospital of Nanchang University

P2, N=43, Not yet recruiting, Xiaofeng Chen

P1/2, N=96, Not yet recruiting, Fujian Cancer Hospital