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Phase I Trial of ZIO-101 in Patients With Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00509782
First Posted: July 31, 2007
Last Update Posted: August 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ziopharm
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

Primary Objectives:

  1. To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors.
  2. To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks.

Secondary Objective:

1. To determine the anti-tumor effects of ZIO-101.


Condition Intervention Phase
Solid Tumors Drug: ZIO-101 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of ZIO-101 in Patients With Solid Tumors

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: Daily for 5 consecutive days repeated every 4 weeks for 1 cycle; evaluation of 4-6 dose escalations to determine an MTD ]

Enrollment: 47
Study Start Date: May 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZIO-101 Drug: ZIO-101
Starting Dose 78 mg/m^2 intravenously daily for 5 consecutive days repeated every 4 weeks.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histological confirmation solid malignancy refractory to conventional standard therapies for their condition.
  2. Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents.
  3. Pediatric patients will be eligible at the discretion of the primary investigator.
  4. ECOG performance status score </= 2.
  5. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods.
  6. Patients must provide written informed consent prior to treatment.
  7. At least four weeks from completion of prior therapy to day 1 of study drug.
  8. Baseline toxicity assessment less than or equal to grade 1 except treatment induced alopecia (NCI Common Terminology Criteria for Adverse Events [CTCAE] version 3.0).
  9. Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values: - Serum creatinine </= 2 times the upper normal limit OR a calculated creatinine clearance </= 50 cc/min. - Total bilirubin </= 2 times the upper normal limit. - Alanine aminotransferase (ALT), OR aspartate aminotransferase (AST) </= 3 times the upper limit of normal.
  10. Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 cells/microL.

Exclusion Criteria:

  1. Uncontrolled systemic infection (documented with microbiological studies).
  2. Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Patient has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Patient experiences symptoms even while at rest.
  3. Concomitant therapy for solid cancer.
  4. Pregnant subjects and those who are breast-feeding.
  5. History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I Endometrial/Cervical Carcinoma or Prostate Carcinoma treated surgically, and non-melanoma skin cancer.
  6. Documented personal or family history of prolonged QT syndrome.
  7. 12 lead electrocardiogram with a corrected QT interval >/= 460 milliseconds.
  8. History of confusion or dementia.
  9. History of seizure disorder.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509782


Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Ziopharm
Investigators
Principal Investigator: Razelle Kurzrock, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00509782     History of Changes
Other Study ID Numbers: 2004-0909
First Submitted: July 30, 2007
First Posted: July 31, 2007
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors
Anti-Tumor Effects
ZIO-101