Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors - Full Text View

Sponsored by:	BiPar Sciences
Information provided by:	BiPar Sciences
ClinicalTrials.gov Identifier:	NCT00298675

Purpose

The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available. Additionally, the safety and tolerability and clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic breast cancer in the phase 1b portion of the study.

Condition	Intervention	Phase
Tumors	Drug: BSI-201 Drug: BSI-201 + irinotecan	Phase I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors

Further study details as provided by BiPar Sciences:

Primary Outcome Measures:

Maximum tolerated dose [ Time Frame: After one cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical Response [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: BSI-201 iv, 2 x weekly
2: Experimental	Drug: BSI-201 + irinotecan i.v.; 2x weekly for BSI-201, 1x weekly for irinotecan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically documented, advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available.
ECOG performance status of 0, 1, or 2
Adequate hematological status
Any prior toxicity from prior chemotherapeutic treatment recovered to grade 1 or grade 0
18 years of age or older
Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
For phase 1b portion only: metastatic breast cancer

Exclusion Criteria:

Hematologic malignancies
Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
Myocardial infarction within 6 months of study day 1, unstable angina, congestive heart failure with NYHA > class II, uncontrolled hypertension
Known positive test for HIV or hepatitis C virus, or chronic active hepatitis
Major surgery within 1 month of study day 1
History of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary cancer with no known active disease present and no curative treatment administered for the last 3 years
History of seizure disorder or currently on anti-seizure medication
Systemic chemotherapy or radiation therapy within 28 days of study day 1
Antibody therapy for treatment of underlying malignancy within 1 month of study day 1
Evidence of liver disease shown by elevated enzymes
Evidence of renal disease shown by serum creatinine > 1.5 x upper limit of normal
Currently receiving platelet of GCF support for any medical condition
Concurrent use of herbal medications taken with the intent to treat cancer
Enrolled in or not yet completed at least 30 days since ending other investigational device or drug study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298675

Contacts

Contact: BiPar Sciences

650-635-6055

Locations

United States, Connecticut
Research Site	Not yet recruiting
new haven, Connecticut, United States
United States, Texas
Research Site	Recruiting
San Antonio, Texas, United States
Research Site	Recruiting
Houston, Texas, United States

Sponsors and Collaborators

BiPar Sciences

More Information

Responsible Party:	BiPar Sciences ( VP Clinical Development )
Study ID Numbers:	BSI-201 20060101
Study First Received:	March 1, 2006
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00298675
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Irinotecan

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009