MDACC Study Summary 2006-0604 (Archived)

Study Summary
No. 2006-0604:.......Advanced Cancers; Solid Tumors......George Blumenschein......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2006-0604

Study Title:	Open Label, Dose Escalation Trial of Oral PXD101 in Patients with Advanced Solid Tumors

Physician

New Patient Referral



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

Dept:	Investigational Cancer Therapeutics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6363 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers Solid Tumors	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Prescreening (2xs), Cycle 1-8, Days 1, 5 or 7, 14, 21

Treatment Agents:	PXD-101	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	For patients on the twice daily dosing, patients will stay overnight two times in the first cycle.

Description/
Intervention:

The goal of this clinical research study is to find the highest tolerated dose
of PXD101 that can be given to patients who have cancer that has spread to
other parts of the body or who have lymphoma. Researchers want to learn if
PXD101 can help to control the disease. Unless you have lymphoma, you will
also have blood drawn for pharmacokinetic (PK) testing. PK testing measures
the amount of study drug in the body at different time points. The safety of
the drug will also be studied, based on the side effects caused by the drug.

Study Objectives / Outcomes

The primary objectives of the study are to determine the safety, tolerability and
pharmacokinetics of orally administered PXD101 and to establish a Maximum Tolerated
Dose (MTD) for once daily dosing and twice daily dosing in patients with advanced solid
tumors.

Secondary objectives include:
-To determine the pharmacokinetics of oral PXD101 when dosed once or twice daily at various dose levels.
-To explore anti-tumor activity.
- To determine the safety, tolerability and anti-tumor activity of orally administered PXD101 to patients with lymphoma.

Study Status Information



Study Activation / Registration Date:	11/17/2006

IRB Review and Approval Date:	08/16/2006

Study Type:	Phase I

Recruitment Status:	Terminated

Projected Accrual:	100

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) Age >/= 18 years.

2) Solid Tumor: Histologically documented diagnosis of primary or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists. Entry will include, but is not limited to patients with androgen-independent prostate cancer, and cancers of the breast, ovary, head and neck, non-small cell lung, bladder, colorectal or kidney. Lymphoma: Relapsed or refractory B-Cell, T-Cell or NK-Cell lymphoma or Hodgkins Disease.

3) At least one evaluable lesion. Lesions must be evaluated by CT-scan, MRI, or bone scan. Patients with prostate cancer, bone disease and rising PSA but no other evaluable disease are eligible and will be evaluated based on PSA. For lymphoma patients, lesions can also be measured by PET and/or evaluated in peripheral blood or bone marrow.

4) Progressive disease: Progressive disease will be defined as new or progressive lesions on CT-scan, MRI, bone scan or by rising PSA.

5) >/= 4 weeks since prior RT or chemotherapy.

6) Karnofsky Performance Status >/= 60%.

7) Solid Tumor: Acceptable liver, renal and bone marrow function including the following: Absolute neutrophil count >/= 1.5 x 10^9/L; Hemoglobin >/= 9.0 g/dl; Platelets >/= 100 x 10^9/L ; Bilirubin </= 1.5 times the upper limit of normal (x ULN) ; Aspartate transaminase (AST) and alanine transaminase (ALT) </= 3.0 x ULN (</= 5.0 x ULN is acceptable if liver has tumor involvement) ; Serum Creatinine </= 1.5 x ULN ; PT-INR/PTT </= 1.5 x ULN or in the therapeutic range if on anticoagulation therapy

8) (cont from #7) Lymphoma: Acceptable liver, renal and bone marrow function including the following: Absolute Neutrophil Count >/= 1.0 x 10^9/L; Platelets >/= 50 x 10^9/L; Bilirubin </= 1.5 times the upper limit of normal (x ULN), or </= 3 times ULN if documented hepatic involvement with lymphoma, or </= 5 times ULN if history of Gilbert's disease; Aspartate transaminase (AST) and alanine transaminase (ALT) </= 3.0 x ULN (</= 5.0 x ULN is acceptable if liver has tumor involvement); Serum Creatinine </= 1.5 x ULN; PT-INR/PTT </= 1.5 x ULN or in the therapeutic range if on anticoagulation therapy.

9) Serum potassium within normal range

10) Estimated life expectancy greater than 3 months

11) Signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

1) Prior treatment with PXD101.

2) Solid Tumor: Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 4 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin or nitrosourea). Lymphoma: No anticancer therapy within 2 weeks except for Rituximab which patients should be off for greater than three months unless there is evidence of disease progression.

3) Lymphoma patients who have relapsed within 100 days of autologous or allogeneic transplantation.

4) Serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.

5) Presence of metastatic disease that, in the opinion of the investigator, would require palliative treatment within 4 weeks of enrollment.

6) Symptomatic brain metastases.

7) Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (NYHA Class III or IV) related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry.

8) A marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval > 500 msec; Long QT Syndrome; the required use of concomitant medication on PXD101 dosing days that may cause Torsade de Pointes.

9) Altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies.

10) Pregnant or breast-feeding women.

11) Men and women of childbearing age and potential, who are not willing to use effective contraception.

12) Major surgery within the last 4 weeks.

13) Known HIV positivity, as safety in this patient population has not been assessed.

Links

Registration Number: NCT00413075
Study Information on Clinical Trials Registry (clinicaltrials.gov)