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five hundred patients suffering malignant cancer from eight wards ( breast , GIT ,gynecological , genitourinary , lung , head and neck, lymphoma and myeloma ,skin and melanoma) ,receiving various chemotherapy protocols .

patients' files are revised according to BCCA reference protocols to report errors which are categorized according to type,and severity including: BSA calculation, the eligibility of the chemotherapy protocol , the dosage form ,dosage , the modification of doses according to toxicity and laboratory data results ,frequency ,duration of treatment , intention of treatment , the omitted or duplicated medications ,and the drug interactions.

the impact of the risk factors on the incidence , and type of prescribing errors are studied including :The tumor type, Cancer stage , co morbid illness,The number of drugs in the treatment regimen ,The route of administration of chemotherapy ,Dosing Frequency of treatment, The toxicity of chemotherapy experienced by the patient, The number of abnormal lab data,The type of abnormal lab data ,the age of patient.

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determine the incidence , type , and severity of prescribing errors in the oncology department

Nagwa A Sabri, clinical pharmacy professor

Amr S Saad, clinical oncology lecturer

It is a cross-sectional study examining a random sample of in- and out-patients, with proven malignant disease receiving chemotherapy, over a period of 6 months from the start of the study who visit the Oncology department, Ain Shams University Teaching Hospitals. The effect of some risk factors on the prescribing error will be studied; these risk factors include the following: Tumor type ,Cancer stage ,type of comorbid illness ,type of medication , type of anti-cancer treatment , number of abnormal lab data ,type of abnormal lab data , the number of drugs in the treatment regimen , the number of side effects after chemotherapy administration, the age of patient ,the dosing frequency of anticancer ,the route of administration .

Summary statistics are performed to describe patient characteristics , frequency, types and classification of medication error; and frequency with which Medication errors occur.

Logistic regression will be applied to the collected data to perform a predictive relation between the risk factors which may be (categorical, continuous, or discrete) and the prescribing errors which are (categorical).

This study will be performed according to the hospital's ethics board. Data on age, cancer diagnosis, cancer stage, comorbid illness, details of the anticancer treatment, and drugs for comorbid illness as well as any laboratory abnormalities will be collected.The data will be collected from medical records review.Progress notes and changes made to patients' medication orders since admission are reviewed.

Drugs are classified as either "active agents" (defined as medications to treat cancer- and/or therapy-related symptoms) or "medications to treat comorbid conditions." A comorbid illness is defined as a non-cancer clinical condition that required pharmacologic treatment .

Prescribing errors will be classified as:

* Incorrect Medication: Medication ordered was not appropriate for patient based on indication, patient-specific variables, or clinical status.
* Medication Omission Error: patient having an indication for which no treatment or inadequate treatment was prescribed.
* Dose error: Under or over dosage of more than 5% of antineoplastic drugs .
* Dose omission: unspecified dosage for the medications.
* Incorrect Treatment Duration: Medication prescribed without an appropriate stop time.
* Potential drug-drug interactions: a modification of the effect of a drug when administered with another drug.
* Duplicate prescribing: two or more drugs from the same class are prescribed to treat the same condition, or different conditions.
* Omitted or improper route of administration: unspecified route, wrong route, or improper route to the patient clinical status.
* Improper medication infusion rate: wrong infusion rate for medications administrated via intravenous route.

The prescribing errors will be identified utilizing:

1. Clinical Oncology guidelines of Ain shams university hospitals.
2. BC cancer agency (BCCA) cancer drug manual
3. .the web site chemocalculator (will be used to identify errors in dose calculation).

4- .Drugs.com (used to identify drug-drug interaction, route of administration errors, dose errors, and infusion rate errors).

5-- Manual search for chemotherapy prescribing errors articles via pubmed., and science direct.

Prescribing errors will be schemed into 3 levels according to their scientific evidence.

1. Established: error confirmed by large clinical trials.
2. Probable: error with high likelihood of occurrence but without definitive randomized clinical trials.
3. Suspect: error likely to occur; data derived from case reports. To confirm the scientific evidence of the error, the investigators need to search BC Cancer Agency , pubmed, science direct and, medical journals literature to ensure the scientific evidence of the error. Reporting medication errors of scientific evidence from 1 to 3 to the physicians via e-mail.

Ranking the severity of the prescribing errors ,in which major, when the potential error could lead to permanent damage or risk of death; moderate, when the clinical consequence of an error requires medical treatment; or minor, when small or no clinical effect is expected from the error .

Clinical pharmacist will discuss and study the effect of the following risk factors on prescribing error:

* The tumor type (breast cancer, lymphoma and myeloma ,lung cancer ,genitourinary cancer ,gynecological cancer , GIT cancer, melanoma,head and neck cancer).
* Cancer stage.

  1. early: indicates Carcinoma in situ
  2. : locally- advanced: indicate more extensive disease: Larger tumor size and/or spread of the cancer beyond the organ in which it first developed to nearby lymph nodes and/or tissues or organs adjacent to the location of the primary tumor
  3. metastatic : indicates The cancer has spread to distant tissues or organs.
* Type of comorbid illness (heart disease /renal disease /hepatic disease /diabetes/ hypertension / gastric disease/ blood abnormality/ osteoporosis).
* The number of drugs in the treatment regimen .
* Type of medication ( active agent ,comorbid illness medication )
* Type of anticancer treatment
* The route of administration of chemotherapy (intravenous, intramuscular, Oral, Intrathecal).
* Dosing Frequency of treatment.
* The number of side effects of chemotherapy administrated experienced by the patient.
* The number of abnormal lab data.
* The type of abnormal lab data (kidney function test ,liver function test ,blood test ).
* The age of patient. Summary statistics of the data will be performed to determine the incidence of prescribing errors in the oncology department of Ain shams university hospitals.

Logistic regression analysis of the data will be performed using SPSS.

* Dependent variable is the presence or absence of prescribing error for which there is reasonable supportive evidence (i.e., scientific evidence levels 1 - 3).
* Explanatory variables (risk factors) are age, cancer type, cancer stage, treatment type, type of comorbid illness, number of drugs, type of medications, the number of laboratory abnormality, type of lab abnormality the route of administration, the frequency of treatment.

Logistic regression is used to model the determinants and predict the likelihood of the prescribing errors in the oncology department, Ain shams university hospital. The impact (coefficient) of each risk factor will be quantitatively correlated to prescribing errors.

Charts will be performed to inform physicians of the prescribing errors of high incidence, as well as, the risk factors increasing the likelihood of prescribing errors.

Enhancement of the Prediction of Chemotherapy Prescribing Errors for Oncology Patients

Cross-sectional Study to Enhance the Prediction of Prescribing Errors for Oncology Patients

to determine the average number of prescribing errors per patient

to determine the enhancement or progression of cancer staging

hadeer ehab

clinical pharmacist

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Lymphoma

Recurrence

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Anti-Infective Agents

Antineoplastic Agents

Sirolimus

Temsirolimus

MTOR Inhibitors

Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.

ARQ 092

This is an open-label, Phase 1, dose escalation study of oral ARQ 092 administered to subjects with advanced solid tumors and recurrent malignant lymphoma. The study is designed to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARQ 092 and to define a recommended Phase 2 dose of ARQ 092.

Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

A Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Digestive System Diseases

Carcinoma

Cholangiocarcinoma

Liver Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Bile Duct Cancer

Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma

Crouzon Syndrome

Jackson-Weiss Syndrome

Pfeiffer Syndrome

Hematinics

Amino Acids

Liver Extracts

Mitogens

Tyrosine Kinase Inhibitors

Tyrosine

Patients who received derazantinib orally at dose levels from 25 mg every other day (QOD) - 200 mg daily (QD) on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Derazantinib was administered orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule.

Derazantinib low dose range

Derazantinib was administered orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule.

Derazantinib middle dose range

Derazantinib was administered orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule.

Derazantinib high dose range

Derazantinib was administered orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule.

Derazantinib at recommended phase 2 dose (RP2D)

Marc Engelhardt, MD

This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR genetic aberrations, including iCCA with FGFR2 gene fusion (Part 2; Expanded Cohort, signal finding).

Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations

A Phase 1/2 Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma With FGFR2 Gene Fusion

Adverse events were graded for severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. CTCAE is classifying AEs and their associated severity from Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences) to Grade 5 (Death related to AE)

The number of patients with an objective tumor response, which included those with either a complete response (CR) or a partial response (PR) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response.

The objective response rate (ORR) was defined as the proportion of patients with a CR or PR.

The number of patients with tumor disease control, which included those with either a complete or partial tumor response, or a stable disease (SD) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response. The disease control rate (DCR) was defined as the proportion of patients with CR, PR or SD.

PFS was calculated as the time from the date of first dose until documented radiographic disease progression or death from any cause, whichever occurred first. Disease progression is measured according to a specified radiologic increase in tumor size.

Basilea Pharmaceutica

Adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Patients who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Derazantinib 25 mg QOD - 200 mg QD - Low Dose Group

Derazantinib 250 mg QOD - 325 mg QD -Middle Dose Group

Derazantinib 400 mg QOD - 425 mg QD - High Dose Group

Derazantinib 300 mg QD - Expanded Cohort Group

Derazantinib 250 mg QOD - 325 mg QD - Middle Dose Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Safety Population (patients who received any amount of derazantinib)

Study Director

The safety population included all subjects who received at least one dose of derazantinib.

Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs)

Evaluable Population: patients who received at least one cycle of study treatment and had at least one postbaseline tumor evaluation.

Proportion of Patients With an Objective Tumor Response Per RECIST 1.1

Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria .

Proportion of Patients With Disease Control Per RECIST 1.1

Progression-free Survival (PFS)

Subjects who received derazantinib orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Subjects who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Subjects who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Subjects who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Enhancement of the Prediction of Chemotherapy Prescribing Errors for Oncology Patients	NCT02435290	Inappropriate P... Clinical Oncolo...	determine the i...	18 Years - 80 Years	Ain Shams University
Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma	NCT01473095	Solid Tumor Malignant Lymph... Tumor	ARQ 092	18 Years -	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant Lymphoma	NCT01473095	Solid Tumor Malignant Lymph... Tumor	ARQ 092	18 Years -	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Enhancement of the Prediction of Chemotherapy Prescribing Errors for Oncology Patients	NCT02435290	Inappropriate P... Clinical Oncolo...	determine the i...	18 Years - 80 Years	Ain Shams University
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations	NCT01752920	Solid Tumor	Derazantinib lo... Derazantinib mi... Derazantinib hi... Derazantinib at...	18 Years -	Basilea Pharmaceutica

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