A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

NCT00886782 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: CA198-002EUDRACT Number: 2009-010572-20
• Study Type: interventional
• Target: 11
• Locations: 3 countries
• Sites: 6

Brief Summary

The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.

Conditions

Advanced Solid Cancers; Metastatic Cancer

Keywords

Advanced and/or Metastatic solid cancers

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Dose Limiting Toxicities (DLTs) of BMS-863233

  DLT is defined based on adverse events that are deemed to be drug-related and occur during the first cycle of therapy using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

  Up to 28 days

• Number of Participants With Adverse Events (AEs)

  Number of participants with any grade adverse events (AEs), any grade drug-related AEs, any grade serious adverse events (SAEs), any grade drug-related SAEs, and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

  From first dose to 30 days post last dose (Up to 14 months)

• Number of Participants Who Died

  Number of participants who died due to any cause.

  From first dose to 30 days post last dose (Up to 14 months)

• Number of Participants With Lab Abnormalities Grade 3-4

  Number of participants with lab abnormalities grade 3-4 including hematology, chemistry, coagulation, liver and kidney function, and electrolytes using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade 3 = severe Grade 4 = very severe

  From first dose to 30 days post last dose (Up to 14 months)

Secondary Outcomes (13)

• BMS-863233 Maximum Observed Plasma Concentration (Cmax)

  PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

• BMS-863233 Time of Maximum Observed Plasma Concentration (Tmax)

  PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

• BMS-863233 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))

  PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

• BMS-863233 Clearance (CL)

  PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

• BMS-863233 Effective Elimination Half-Life (T-HALFeff)

  PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 36-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14

Study Arms (1)

Cdc7-inhibitor

EXPERIMENTAL

Drug: Cdc7-inhibitor

Interventions

Cdc7-inhibitor DRUG

Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months

Also known as: BMS-863233, XL413

Cdc7-inhibitor

Eligibility Criteria

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

You may qualify if:

• Subjects with advanced and/or metastatic solid tumors who are either refractory to or have relapsed from standard therapies, or for whom a standard therapy does not exist.
• ECOG performance status ≤ 2
• Accessible for treatment, PK sample collection and required study follow-up
• Total Bilirubin ≤ 1.5 x ULN and ALT, AST ≤ 2.5 x ULN

You may not qualify if:

• Women who are pregnant or breastfeeding
• Subjects with known or suspected brain metastasis, primary brain tumors, or brain as the only site of disease
• Exposure to any investigational agent within 4 weeks of study drug administration
• Subjects a history of gastrointestinal disease

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Exelixis: collaborator

Study Sites (6)

Dana-Farber Cancer Institute-Vendor

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Local Institution - 003

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution

Villejuif, 94800, France

Location

Related Links

• Investigator Inquiry form
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

Clinical.Trials@bms.com

Please Email

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: May 31, 2009
• Primary Completion: August 4, 2010
• Study Completion: August 4, 2010
• Last Updated: April 28, 2023
• Results First Posted: April 28, 2023

Record last verified: 2023-04

Locations

US (3); CA (2); FR (1)