Quinoline compound for combined treatment on carcinoma of colon and rectum

A colorectal cancer and compound technology, applied in the field of pharmaceutical preparations and medicine, can solve problems such as strong side effects and lack of more effective therapeutic drugs

Pending Publication Date: 2020-12-08
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Based on the strong side effects of high-dose multi-drug combined chemotherapy and the lack of more effective therapeutic drugs, it is necessary and urgent to further improve the curative effect

Method used

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  • Quinoline compound for combined treatment on carcinoma of colon and rectum
  • Quinoline compound for combined treatment on carcinoma of colon and rectum
  • Quinoline compound for combined treatment on carcinoma of colon and rectum

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0206] Example 1 Phase I / II exploratory study of anlotinib combined with irinotecan in the second-line treatment of mCRC

[0207] In patients with histologically and / or cytologically confirmed advanced metastatic colorectal cancer, combined administration of anlotinib and irinotecan, anlotinib once a day (qd) for 2 weeks and rest for 1 week, combined Irinotecan 180mg / m 2 , injected once every two weeks in each cycle, every 42 days as a treatment cycle, collecting safety information until disease progression or toxicity intolerable, so as to determine the efficacy of anlotinib combined with irinotecan in patients with advanced colorectal cancer The maximum tolerated dose (MTD, Maximum Tolerated Dose) and / or the recommended phase II dose (RP2D, Recommended Phase II Dose). The specific dosage regimen has the following three dosage groups from low to high:

[0208] A: Anlotinib 8mg qd, take two weeks and take one week off, + irinotecan 180mg / m 2 , injected once every two weeks;...

Embodiment 2

[0214] Example 2 Anlotinib hydrochloride combined with CAPEOX regimen for first-line treatment of RAS / BRAF wild-type advanced mCRC

[0215] Patients with stage IV (T1-4N0-2M1) unresectable or potentially resectable locally advanced, locally recurrent or metastatic colorectal cancer confirmed by histopathology, in which the primary tumor or metastatic tumor is detected as RAS / BRAF wild-type patients who have not previously received systemic therapy, including chemotherapy, targeted and immunotherapy, or (neo) adjuvant chemoradiotherapy / radical surgery for more than 6 months of recurrence, combined administration of anlotinib and CAPEOX Program. The specific administration method is as follows, and the following medicines all adopt 3 weeks (21 days) as a treatment cycle:

[0216] Anlotinib hydrochloride 12mg, orally once a day, on days 1-14 of each cycle;

[0217] Oxaliplatin 130mg / m 2 , intravenous drip, medication on the first day of each cycle;

[0218] Capecitabine 1000...

Embodiment 3

[0222] Example 3 First-line treatment of advanced mCRC with anlotinib hydrochloride combined with CAPEOX regimen

[0223] In patients with histologically or cytologically confirmed colon or rectal adenocarcinoma, combined administration of anlotinib and CAPEOX regimen.

[0224] The specific administration method is as follows:

[0225]

[0226] Among them, at least 6 cycles of initial treatment, capecitabine: 1000mg / m 2 , calculated based on the patient's body surface area at baseline.

[0227] To evaluate the efficacy and safety of anlotinib combined with CAPEOX regimen in the first-line and maintenance treatment of patients with metastatic colorectal cancer. The observed indicators are mainly progression-free survival (PFS), objective response rate (ORR), duration of response ( DOR), disease control rate (DCR) and safety indicators.

[0228] Clinical trial results: 3 patients have been evaluated so far, of which 1 patient achieved PR (Partial Response), and 2 patients ...

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Abstract

The application belongs to the technical field of medicines, provides a quinoline compound for combined treatment on the carcinoma of the colon and rectum and particularly provides use of combinationof a compound I or pharmaceutically acceptable salts thereof and a second therapeutic agent in preparation of drugs for treating the carcinoma of the colon and rectum and a combined pharmaceutical composition for treating the carcinoma of the colon and rectum. The combined pharmaceutical composition comprises: (i) the compound I or pharmaceutically acceptable salts thereof; and (ii) at least one second therapeutic agent, wherein a chemical name of the compound I is 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinol-7-yl]oxy]methyl]cyclopropylamine.

Description

technical field [0001] The invention belongs to the field of medicine, and the invention belongs to the technical field of pharmaceutical preparations, in particular to a quinoline compound or a pharmaceutically acceptable salt thereof for combined treatment of colorectal cancer. Background technique [0002] Colorectal cancer (carcinoma of colon and rectum, mCRC) is one of the most common malignant tumors, ranking third and fourth in terms of morbidity and mortality, and about 1.2 million patients worldwide die directly or indirectly from colorectal cancer every year . The incidence of colorectal cancer varies greatly in different regions of the world. Compared with developing countries in Asia and Africa, developed countries such as Europe and the United States are relatively higher. Due to the influence of the so-called Western-style life, the incidence rate of the original low-risk disease also showed a rapid increase trend. With the change of people's lifestyle and di...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4709A61K45/06A61P35/00
CPCA61K31/4709A61K45/06A61P35/00
Inventor 梁洪铭张喜全王训强于鼎申丽丽李琨
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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