Trial of PBI-05204 in Advanced Cancer Patients
This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: November 2, 2007
Last updated: April 23, 2013
Last verified: April 2013
The goal of this clinical research study is to find the highest safe dose of PBI-05204 that can be given to patients with advanced solid tumors. The study will also look at how PBI-05204 is processed by the body, how it leaves the body, how it affects the body, and if it is affecting certain proteins in the cancer cells.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open Label Phase I Trial of PBI-05204 in Advanced Cancer Patients
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: Continuous assessment of safety throughout entire study period and determination of dose-limiting toxicities during and at the end of 28 Day Cycle(s). ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
PBI-05204 starting dose = 0.0083 mg/kg/day by mouth (PO) x 3 weeks per cycle.
Starting dose = 0.0083 mg/kg/day by mouth (PO) x 3 weeks per cycle
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Participants must have an ECOG performance status score of 0-1
- Histologic or cytologic diagnosis of a primary solid malignancy
- Evidence (radiographic or tissue confirmation) that the disease is metastatic, or locally advanced in patients who are not candidates for standard therapy
- Measurable disease, as defined by RECIST
- Adequate bone marrow function defined as: a) absolute neutrophil count (neutrophil and bands) >/= 1,500 cells/mm3; b) platelet count >/= 100,000 cells/mm^3; c) hemoglobin >/= 9.0 g/dl
- Adequate hepatic function defined as: a) total bilirubin </= 1.5 times the institutional upper limit ULN; b) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 2.0 times the institutional ULN; c) Exception: patients with primary liver tumors or known liver metastases: </= 3.0 times the institutional ULN for AST and ALT
- Adequate renal function defined as serum creatinine </= 1.5 times the institutional ULN
- Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal. Patients with low potassium, calcium and magnesium levels may be repleted to allow for protocol entry.
- Prior chemo-, radio-, hormonal or immunotherapy are allowed. At least 4 weeks must have elapsed since the last chemotherapy or investigational agent (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin), immunotherapy or radiotherapy and the beginning of protocol therapy. At least 2 weeks must have elapsed since last hormonal therapy or exposure to any other targeted kinase inhibitor (e.g., imatinib mesylate).
- Men and women, ages 18 and older.
- Women of childbearing potential (WOCBP) must be using an adequate method (i.e. barrier, spermicidal) of contraception to avoid pregnancy throughout the study and for a period of at least 1 month prior and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
- continued from 11: WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea >/= 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL].
- continued from 12: Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
- Participants must sign the written informed consent
- Participants must be available for protocol-required follow-up
- WOCBP who are unwilling or unable to use an acceptable method (i.e. barrier, or spermicidal) to avoid pregnancy for the entire study period including the period from one month prior to starting study medication and for a period of at least 3 months after the study.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) on enrollment or prior to study drug administration.
- Men who are unwilling or unable to use an acceptable method (i.e. barrier, or spermicidal) of birth control for the entire study period and for at least 3 months after completion of study medication if their sexual partners are WOCBP.
- Received extensive prior radiation therapy to the bone marrow. Generally, patients should have radiation to </= 25% of bone marrow-containing skeleton.
- Symptomatic brain metastases that are either untreated or uncontrolled by surgery and or radiotherapy. Patients with symptoms of brain metastasis are not eligible unless brain metastasis are ruled out by CT or MRI and/or fully treated surgically or with WBRT.
- A serious uncontrolled medical disorder or active infection which would impair the ability of the patient to receive protocol therapy.
- Uncontrolled or significant cardiovascular disease, including: a) A myocardial infarction within 6 months b) Uncontrolled angina within 3 months c) Congestive heart failure within 3 months defined as NYHC-II d) Diagnosed or suspected congenital long QT syndrome
- continued from 8: e) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes). Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec). If the automated reading is prolonged (i.e., > 450 msec), the ECG should be manually overread. f) Any history of second or third degree heart block (may be eligible if currently have a pacemaker) g) Heart rate < 50 / minute on pre-entry electrocardiogram h) Uncontrolled hypertension (blood pressure >140 sys. and >90 dia.)
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- Patients who have not recovered from adverse events greater than grade 1 due to agents administered more than 4 weeks earlier.
- Prior exposure to PBI-05204
- Subjects taking these medications: digoxin/digitoxin, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, sotalol, and quinidine. Subjects taking non-potassium sparing diuretics (with the exception of lasix or furosemide) or other investigational drugs.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with myelosuppressive therapy, patients known to have tested HIV-positive are excluded from the study.
- Social situations that would limit compliance with study requirements.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to PBI-05204, or other agents used in this study
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554268
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||David S. Hong, MD
||M.D. Anderson Cancer Center
No publications provided by M.D. Anderson Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 2007
||April 23, 2013
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
ClinicalTrials.gov processed this record on February 11, 2016