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Anti-CTLA4 antibody and indolinone combination therapy for treatment of cancer

A technology of -CTLA4 and antibody, which is applied in the field of combined therapy of anti-CTLA4 antibody and indolinone for the treatment of cancer, can solve the problems of less complete response to treatment and great resistance to treatment methods in patient groups.

Inactive Publication Date: 2008-03-19
PFIZER PRODS ETAT DE CONNECTICUT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Similarly, despite the success of existing anticancer treatments, complete responses to said treatments rarely occur and patient populations remain resistant to these treatments

Method used

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  • Anti-CTLA4 antibody and indolinone combination therapy for treatment of cancer
  • Anti-CTLA4 antibody and indolinone combination therapy for treatment of cancer
  • Anti-CTLA4 antibody and indolinone combination therapy for treatment of cancer

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0260] Combination of Anti-CTLA4 Antibody with Indolinone RTK I (Compound 1) Effects Stem Metastasis of Kidney Cells First-line treatment for cell carcinoma

[0261] After surgery / radiation therapy, patients with metastatic renal cell carcinoma (RCC) have at least one lesion, if any, that can be accurately measured in two dimensions and its size measured by conventional CT scans Patients > 2 cm x 1 cm or > 1 cm x 1 cm as measured by helical CT scans were offered standard chemotherapy with Compound 1 (SU11248) by established methods. Briefly, Compound 1 was administered orally once daily at approximately 50 mg / day for a period of 4 weeks. Following a two-week rest period, patients were administered a second course of Compound 1 for a four-week period. Cycles of Compound 1 administration followed by drug withdrawal were repeated as described above.

[0262] The patient is also administered an IV infusion (100 mL / hr) of anti-CTLA4 antibody at a dose of approximately 3 mg / kg...

example 2

[0271] Anti-CTLA4 antibody combined with indolinone RTKI for metastatic renal cell carcinoma line therapy

[0272] After surgery / radiation therapy, patients with metastatic renal cell carcinoma (RCC) have at least one lesion, if any, that can be accurately measured in two dimensions and its size measured by conventional CT scans Patients > 2 cm x 1 cm or > 1 cm x 1 cm as measured by helical CT scans were offered standard chemotherapy with indolinone RTKI (Compound 1, Compound 2 or Compound 3) by established methods. Briefly, Compound 1 was administered orally once daily at approximately 50 mg / day for a period of 4 weeks. Following a two-week rest period, patients were administered a second course of four-week compound treatment. Repeat administration of the compound was followed by intermittent treatment with rest periods as indicated.

[0273] The patient is also administered an IV infusion (e.g., 100 mL / hr and 200 mL / hr, etc.) of anti-CTLA4 antibody at a dose of approx...

example 3

[0282] Combination of anti-CTLA4 antibody and indolinone RTK I in the treatment of imatinib-resistant gastrointestinal tract stromal carcinoma (G I ST)

[0283] Patients with imatinib-resistant GIST were treated with standard chemotherapy using an indolinone RTKI (compound 1 ) following surgery / radiation therapy, if available, using established methods. Briefly, Compound 1 was administered orally once a day at approximately 50 mg / day for a period of 4 weeks. Following a two week rest period, patients are administered a second course of compound over a four week period. Treatment cycles of compound 1 administration followed by rest periods were repeated as indicated.

[0284] The patient is also administered an IV infusion (100 mL / hr) of anti-CTLA4 antibody at a dose of approximately 1 mg / kg, 3 mg / kg, 6 mg / kg, 10 mg / kg or 15 mg / kg according to the instructions herein. Use prophylactic anti-emetic and anti-diarrheal agents as needed. Antibody treatment was repeated after ...

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Abstract

The present invention relates to the administration of anti-CTLA4 antibodies, particularly human antibodies against human CTLA4, such as with antibodies 3.1.1, 4.1.1, 4.8.1, 4.10.2, 4.13.1, 4.14.3, 6.1.1, ticilimumab (also known as 11.2.1 or CP-675, 206), 11.6.1, 11.7.1, 12.3.1.1, 12.9.1.1, and antibodies to the amino acid sequences of ipilimumab (also known as 10D1 or MDX-010) , with an indolinone receptor tyrosine kinase inhibitor (RTKI), for example, N-[2-diethylamino]ethyl]-5-[(Z)-(5-fluoro-2-oxo-1, 2-dihydro-3H-indole-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carbamoyl (compound 1), N-[2-(ethylamino) Ethyl]-5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H -pyrrole-3-carbamoyl (compound 2), and 5-[(Z)-(5-fluoro-2-oxo-1,2-dihydro-3H-indole-3-ylidene)methyl] -N-[(2S)-2-Hydroxy-3-morpholin-4-ylpropyl]-2,4-dimethyl-1H-pyrrole-3-carbamoyl (compound 3) combination for the treatment of cancer. The present invention relates to the administration of an anti-CTLA4 antibody in combination with an indolinone RTKI, such as, in particular, Compound 1. The present invention relates to neoadjuvant, adjuvant, first-line, second-line, and third-line treatments of cancer, whether localized or metastatic, and at any point in disease progression (eg, at any stage of the cancer).

Description

Background of the Invention [0001] Cancer is currently the leading cause of death in the United States. Currently, cancer is treated with one or a combination of three types of treatments: surgery, radiation, and chemotherapy. Chemotherapy involves disrupting cell replication or cell metabolism. The negative effects of systemic chemotherapy for the treatment of neoplastic diseases can be life-threatening and constitute a major task in the clinical management of cancer patients. [0002] The development of targeted therapy has focused on the specific targeting of tumor cells while sparing normal tissues in order to reduce side effects. Targeted therapy focuses on angiogenesis because as tumor cells grow they require a source of nutrients. Growth factors specifically produced by tumor cells (e.g., VEGF and PDGF) stimulate angiogenesis to form new blood vessels that provide vital nutrients and provide a means for tumor cell metastasis (Klagsburn and D'Amor e, 1996, Cy t ok i ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P35/00C07K16/28
CPCC07K2317/21A61K39/39541A61K2039/505C07K16/2818A61K31/404A61K45/06A61P31/00A61P35/00A61P35/04A61P37/04A61P43/00A61K2300/00A61K39/395A61K31/403A61K31/5377
Inventor J·格梅斯-纳瓦罗C·M·鲍姆
Owner PFIZER PRODS ETAT DE CONNECTICUT
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