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Method to treat small cell lung cancer

A technology for small cell lung cancer and therapy, applied in botany equipment and methods, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems that chemotherapy does not meet the requirements, etc.

Inactive Publication Date: 2013-08-21
PONIARD PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Therefore, there still clearly remains an unmet need in the industry for improved chemotherapy for SCLC

Method used

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  • Method to treat small cell lung cancer
  • Method to treat small cell lung cancer
  • Method to treat small cell lung cancer

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0058] Example 1. Phase II Study

[0059] Phase II study of picoplatin monotherapy in patients with co-occurring SCLC with non-responsive SCLC, or SCLC that responded to first-line therapy but then progressed within 90 days of completion of first-line therapy, or progressed at 91-180 days Disease (as defined herein). Use picoplatin at 150mg / m 2 Doses administered intravenously every 21 days over a 1-2 hour period treated a cohort of 77 patients with measurable disease comprising 44 SCLC patients treated with first-line organoplatinum chemotherapy (cisplatin, carboplatin, or oxali Platinum) nonresponders and 27 SCLC relapsed within 90 days of stopping first-line therapy and 6 patients with progressive SCLC between 91 and 180 days old. Picoplatin is supplied as a sterile isotonic 0.5 mg / mL aqueous solution for IV infusion.

[0060] Patients received 1-10 cycles of picoplatin. The median number of dose cycles administered was 2 and the mean number of dose cycles was 3. Adver...

example 2

[0076] Example 2. Phase III study

[0077] introduce

[0078] In non-responsive SCLC patients or responsive SCLC patients (including refractory and sensitive patients, as defined above) who show progressive disease within 180 days, conduct a phase III clinical study to illustrate the difference with best supportive care (BSC) only Median survival superiority compared with picoplatin monotherapy versus best supportive care.

[0079] Documentation about the treatment of the disease

[0080] Radiation therapy documentation for disease prior to first-line therapy must be available so that disease status at study baseline can be assessed for protocol eligibility and stratification purposes. The investigators determined eligibility by comparing chest x-rays or computed tomography (CT) scans obtained before, during, and after first-line chemotherapy. During screening, a baseline CT or magnetic resonance imaging (MRI) scan is performed for tumor evaluation.

[0081] The radiol...

example 3

[0463] Example 3. Treatment of SCLC brain metastases

[0464] Intracranial orthotopic SCLC model

[0465] Charles River Laboratories, Discovery and Imaging Services (formerly MIR Preclinical Services), Ann Arbor, MI in an Orthotopic Model of SCLC Brain Metastases (Ann Arbor, MI)) to evaluate picoplatin efficacy. will be 10 6 DMS114ACLC cells were implanted intracranially into 9-10 week old female athymic nude mice (outbred nu / nu). Treatment with vehicle or picoplatin (35 mg / kg) was initiated on day 18 with a dosing regimen of Q7DX4 at a mean tumor weight of 13 mg. Tumor mass and doubling time (Td) were assessed twice weekly using magnetic resonance imaging (MRI). use[ 18 F] Fluorothymidine positron emission tomography (FLT PET) as an indicator of tumor proliferation index, which is expressed in the form of standardized uptake value (SUV), and calculated as follows: SUV = (average tumor 18 F activity (μCi / g) x body weight (g)) ÷ decay-adjusted injected dose (μCi).

[0...

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PUM

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Abstract

A method for treatment of small cell lung cancer (SCLC) that does not respond to first-line treatment or that progresses following cessation of first-line organoplatinum chemotherapy is provided that includes the administration of picoplatin, optionally in conjunction with a regimen of best supportive care. Multiple doses of picoplatin can be administered. The picoplatin can also treat SCLC that has metastacized to the brain.

Description

[0001] Cross reference to related applications [0002] This application claims Serial Nos. 61 / 311,169, filed March 5, 2010; 61 / 345,442, filed May 17, 2010; 61 / 345,451, filed May 17, 2010; and 2010 Priority to U.S. Provisional Application No. 61 / 346,777, filed May 20, 2011, which is incorporated herein by reference. technical field Background technique [0003] Small cell lung cancer (SCLC) accounts for approximately 14% of all lung cancers. In 2004, there were about 26,000 new cases in the United States and about 51,000 new cases in Europe (Jemal, 2004). The median survival of patients with untreated SCLC is 2 to 4 months (Clark, 1998; Glisson, 2003; Davies, 2004). Combination chemotherapy is considered the standard first-line therapy currently used in SCLC. The most common regimens contain platinum (Pt) drugs such as cisplatin or carboplatin and etoposide. Unfortunately, despite a 40-90% response rate to first-line chemotherapy, long-term survival is often not possibl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N55/02A61K33/243
CPCA61K31/28A61P35/00A61P35/04A61K33/243A61K31/555A61K45/06
Inventor 黑兹尔·B·布莱茨罗伯特·德亚赫保罗·L·魏登
Owner PONIARD PHARMA INC
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