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A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

Thank you

Trial Information

A Phase 1B, Open-Label, Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors


Inclusion Criteria:



- ≥ 18 years old with a histologically or cytologically documented, advanced solid
tumor

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (without granulocyte
colony-stimulating factor [G-CSF] support within 2 weeks of study day 1); platelet
count ≥ 100.0 x 10^9/L (without transfusion within 2 weeks of study day 1); and
hemoglobin ≥ 9.0 g/dL (erythropoietic agents allowed)

- At least a 14-day period from end of last dose of chemotherapy received

- Any prior toxicity from prior chemotherapeutic treatment recovered to ≤ grade 1

Exclusion Criteria:

- Subject enrolled in another investigational device or drug trial, or is receiving
other investigational agents

- Hematological malignancies

- Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive
of but not limited to surgery, radiation, and corticosteroids.

- History of seizure disorder

- Myocardial infarction (MI) within 6 months of study day 1, unstable angina,
congestive heart failure (CHF) with New York Heart Association (NYHA) > class II, or
uncontrolled hypertension

- Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low dose
for port maintenance allowed)

- Specified concomitant medications

- Serum creatinine > 1.5 x upper limit of normal (ULN)

- Elevated liver enzymes (AST/ALT) > 2.5 x ULN, or > 5.0 x ULN if secondary to liver
metastases; alkaline phosphatase > 2.5 x ULN or > 5.0 x ULN if secondary to liver or
bone metastases; total bilirubin > 1.5 x ULN

- Radiation therapy within 14 days of study day 1

- Antibody therapy for the treatment of an underlying malignancy within 14 days of
study day 1

- Concurrent radiation therapy is not permitted throughout the course of the study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

safety and efficacy

Outcome Time Frame:

ongoing

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

TCD11484

NCT ID:

NCT00422682

Start Date:

January 2007

Completion Date:

September 2011

Related Keywords:

  • Tumors
  • Solid tumors

Name

Location

Research SiteDanbury, Connecticut  
Research SiteBattle Kreek, Michigan  
Research SiteAlbany, New York  
Research SiteAllentown, Pennsylvania  
Research SiteAbilene, Texas