MDACC Study Summary 2008-0194

Study Summary
No. 2008-0194:.......Pancreas......David Fogelman......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2008-0194

Study Title:	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 (20060102)

Physician

New Patient Referral



Name:	David Fogelman	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gastrointestinal Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2828 Contact us about clinical trials

General Information



Disease Group:	Pancreas	Supported By:	BiPar Sciences Inc.

Phase of Study:	Phase I	Return Visit:	Twice a week, every third or fourth day. One cycle is 28 days.

Treatment Agents:	BSI-201 Gemcitabine	Home Care:	NA

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	The goal of this clinical research study is to learn if and how pancreatic cancer may be affected by BSI-201 in combination with gemcitabine hydrochloride. The safety of this combination will also be studied.

Study Objectives / Outcomes

Please note: This is a multicenter study for advanced solid tumors (including advanced ovarian, sarcoma, and non-small cell lung cancer (NSCLC). MDACC will only take part in Arm 3 of the Study Arm Concentration Phase - (Gemcitabine) in Pancreatic Cancer.
Study Arm Concentration Phase (MDACC participation) objectives are as follows:
Primary
· To evaluate the response in study subjects (per RECIST) with measurable disease, dosed with a fixed combination (BSI-201 plus chemotherapeutic agent regimen) dose level
Secondary
· To assess safety profiles: significant laboratory changes and adverse events (AEs).
Exploratory
· To assess the extent and duration of PARP inhibition with combination therapy.
To assess the relationship between BRCA status and response in subjects with pancreatic or ovarian cancer.

Study Status Information



Study Activation / Registration Date:	10/27/2008

IRB Review and Approval Date:	10/27/2008

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	152

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) At least 18 years of age

2) Eastern Oncology Cooperative Group (ECOG) performance status of </=1

3) Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (without GCF 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)

4) Subjects must have recovered (toxicity recovered to </= grade 1) from effects of recent surgery, radiotherapy or other therapy

5) The subject has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques or as >/=10 mm with spiral computerized tomography (CT) scan

6) Signed, IRB approved written informed consent

7) Patients previously treated on this protocol who have come off study for reasons not related to disease progression or toxicity may be re-entered into the study.

8) For STUDY ARM CONCENTRATION PHASE - Gemcitabine (Arm 3) - Pancreatic Cancer: Patients must have histological or cytologically confirmed adenocarcinoma of the pancreas.

9) For STUDY ARM CONCENTRATION PHASE - Gemcitabine (arm 3) - Pancreatic Cancer: Either a known BRCA 1 or 2 mutation identified by commercial assay, or a family history of at least 2 first degree relatives (parent, sibling, offspring), or 3 first or second degree relatives (grandparent, grandchild, uncle, aunt, nephew, niece, half-sibling) with BRCA 1-2-related cancers (breast, ovarian, prostate, pancreas, buccal cavity, pharynx, stomach, gallbladder, bile ducts, lymphoma, or melanoma) will be considered eligible for enrollment. Patients with personal or family histories of PALB2, FANC protein, RAD51, or other BRCA pathway mutations may also be included.

Exclusion Criteria:

1) Hematological malignancies

2) Other active metastatic malignancies

3) Primary brain tumors

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

5) Myocardial infarction (MI) within 6 months of study day 1, unstable angina, congestive heart failure [CHF] with New York Heart Association [NYHA] > class II, uncontrolled hypertension (2 or more readings of 140/90)

6) Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, or chronic active hepatitis B infection

7) Major surgery within 1 month of study day 1, unless approved by the sponsor

8) History of seizure disorder or currently on anti-seizure medication

9) Any co-morbid medical condition that, in the opinion of the investigator, would increase the risk of toxicity

10) Serum creatinine > 1.5 x ULN

11) 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 bone or liver metastases; or total bilirubin > 1.5x ULN

12) Systemic chemotherapy within 14 days of study day 1

13) Radiation therapy within 14 days of study day 1

14) Antibody therapy for treatment of underlying malignancy within 14 days of study day 1

15) Concurrent use of herbal medications taken with the intent to treat cancer or ameliorate side effects, including St. John's Wort.

16) Currently receiving platelet or G-CSF support for any medical condition

17) Concurrent chemotherapy with any agent other than BSI-201 and the protocol mandated co-administered chemotherapeutic treatment is not permitted throughout the course of the study

18) Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) not approved for any indication

19) Subject of child-bearing potential who is evidently pregnant (e.g., positive HCG test) or breast feeding

20) Subject of child-bearing potential, or subject who has a partner of childbearing potential, and is not using adequate contraceptive precautions

21) Subject will not be available for follow-up assessment

22) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures

23) The subject has received radiation to >/=25% of his or her bone marrow within 30 days of treatment

24) For STUDY ARM CONCENTRATION PHASE - Gemcitabine (Arm 3) - Pancreatic Cancer: Immune-suppressive therapy < 4 weeks prior to inclusion

25) For STUDY ARM CONCENTRATION PHASE - Gemcitabine (Arm 3) - Pancreatic Cancer: Known sensitivity to any components of BSI-201 or gemcitabine

Links

Registration Number: NCT00422682
Study Information on Clinical Trials Registry (clinicaltrials.gov)