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Study of Dasatinib (BMS-354825) in Patients With Solid Tumors

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tumors

Intervention: Dasatinib (Drug); Dasatinib (Drug); Dasatinib (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The primary objective of this study is to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of Dasatinib (BMS-354825) in patients in Japan.

Clinical Details

Official title: A Phase I Study of BMS-354825 in Patients With Solid Tumors

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD) and Maximum Acceptable Dose (MAD) of Dasatinib as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to Dasatinib Treatment

Secondary outcome:

Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs (SAEs), Drug Related AEs and Discontinued Due to AEs

Number of Participants With Grade 3 or 4 Hematology Abnormalities

Number of Participants With Grade 3-4 Serum Chemistry Abnormalities

Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=10% Participants: Low Lymphocyte Count

Most Frequent Serum Chemistry Laboratory Abnormalities Occurring in >=10% Participants: High Magnesium

Number of Participants With Clinically Meaningful Physical Examination Measures

Number of Participants With Clinically Meaningful Vital Signs

Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

Number of Participants With Clinically Significant Change in QT Interval Corrected for Heart Rate (QTcF)

Maximum Plasma Concentration (Cmax) of Dasatinib

Area Under the Plasma-concentration-time Curve [AUC (INF)] of Dasatinib on Day 1

AUC[TAU] of Dasatinib

Time to Reach Maximum Observed Plasma Concentration of Dasatinib (Tmax)

Terminal Elimination Half-life (T-half) of Dasatinib

Accumulation Index (AI) of Dasatinib

Mean Apparent Oral Clearance (CLo) of Dasatinib

Mean Apparent Volume of Distribution (Vz/F) of Dasatinib

Cmax of Metabolite BMS-582691

AUC (0-t) of Metabolite BMS-582691

Tmax of the Metabolite BMS-582691

Mean Urine Concentration of Urinary N-telopeptide Type 1 Collagen (NTx) Biological Marker

Mean Urine Concentration of Deoxypyridinoline (Dpyr) Biological Marker

Mean Serum Concentration of Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP-5b) Biological Marker

Mean Serum Concentration of Bone Alkaline Phosphatase (BAP) Biological Marker

Number of Participants With Sarcoma (Src) and Phosphorylated Src (pSRc) Protein Expression in Peripheral Blood Mononuclear Cells (PBMC)

Number of Participants With Complete Response (CR) or Partial Response (PR)

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Performance status (general conditions) specified by the Eastern Cooperative Oncology

Group: 0-2

- Histologic or cytologic diagnosis of a solid tumor which has progressed on or

following standard therapies (including relapsed disease) or for which no standard therapy exists.

- men and women, ages 20 and over

- women of childbearing potential (WOCBP) must be using an adequate method of

contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized

- Adequate hepatic function

Exclusion Criteria:

- Participants who are eligible and willing to undergo transplantation at pre- study.

- Women who are pregnant or breastfeeding with known brain metastasis or symptoms of

brain metastasis

- Uncontrolled or significant bleeding disorder unrelated to a primary tumor

- Dementia or mental illness that would prohibit understanding or giving informed

consent.

- Severe allergy to drugs required for appropriate supportive care of patients in this

study.

- History of gastrointestinal surgery or of any digestive disorder which has the

potential to inhibit absorption of the study drug.

- Pleural effusion > Grade 1

- Patient with dysphagia

- Does not agree to blood/blood products transfusion(s)

- Donated blood over 200 mL within 4 weeks prior to the start of study therapy

- Medication that known to have a risk of causing Torsade de pointes

- Participants who are compulsorily detained for legal reasons or treatment of either a

psychiatric or physical (e. g., infectious disease) illness must not be enrolled into this study

Locations and Contacts

Local Institution, Osakasayama City, Osaka 589-0014, Japan

Local Institution, Koto-Ku, Tokyo 135-0063, Japan

Additional Information

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: January 2007
Last updated: November 19, 2010

Page last updated: August 23, 2015

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