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

NCT00339144 | Completed Phase 1 Results DMC

• 1 other identifier: CA180-058
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tumors

Keywords

Solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists

Outcome Measures

Primary Outcomes (1)

• 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

  MAD: highest dose level at which \>=1 DLTs were reported, MTD: dose one step lower than MAD. DLT: any of the following considered related to dasatinib during course 1:Grade 3(dose reduction by 1 dose level)/Grade 4:recurring nausea, vomiting or diarrhea; any other Grade \>=3 non-hematologic toxicity except alopecia or fatigue;any grade toxicity requiring two dose reductions or participant's discontinuation; Grade 4 neutropenia \<500 cells/mm\^3 for \>=5 consecutive days or febrile neutropenia; Grade 4 thrombocytopenia \<25,000 cells/mm\^3 or Grade 3 bleeding requiring platelet transfusion.

  From start of the treatment i.e.Day 1 to end of Cycle 1 i.e. Day 30 (4 weeks)

Secondary Outcomes (26)

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

  From start of study drug therapy up to 30 days after the last dose.

• Number of Participants With Grade 3 or 4 Hematology Abnormalities

  From start of study drug therapy up to 30 days after the last dose.

• Number of Participants With Grade 3-4 Serum Chemistry Abnormalities

  From start of study drug therapy up to 30 days after the last dose.

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

  From start of study drug therapy up to 30 days after the last dose.

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

  From start of study drug therapy up to 30 days after the last dose.

Study Arms (3)

Dasatinib (100 mg)

EXPERIMENTAL

Drug: Dasatinib

Dasatinib (150 mg)

EXPERIMENTAL

Drug: Dasatinib

Dasatinib (200 mg)

EXPERIMENTAL

Drug: Dasatinib

Interventions

Dasatinib DRUG

tablets, Oral, 100 mg, once daily for 4 weeks

Also known as: Sprycel, BMS-354825

Dasatinib (100 mg)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution

Sayama, Osaka, 589-0014, Japan

Location

Local Institution

Koto-Ku, Tokyo, 135-0063, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Dasatinib

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 20, 2006
• Study Start: January 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 15, 2010
• Results First Posted: December 15, 2010

Record last verified: 2010-11

Locations

JP (2)