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Phase I Study of TAS-106 in Combo With Carboplatin
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
Taiho Pharmaceutical Co., Ltd.
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00752011
  Purpose

Primary Objectives:

  • To determine the maximum tolerated dose (MTD) of the combination of TAS-106 and carboplatin administered by intravenous infusion every 3 weeks.
  • To perform Pharmacokinetic (PK) analysis of TAS-106 and carboplatin

Secondary Objectives:

  • To assess the antitumor activity of TAS-106 combined with carboplatin
  • To investigate the relationship between selected biomarkers and efficacy and safety outcomes.

Condition Intervention Phase
Cancer
Solid Tumors
Drug: TAS-106
Drug: Carboplatin
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Carboplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors

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

Primary Outcome Measures:
  • To find highest safe dose of the combination of TAS-106 and carboplatin that can be given to patients with advanced cancer or cancer that has spread. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To review relationship between selected biomarkers and efficacy/safety outcomes. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: September 2008
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Day 1 of each 3 week cycle, carboplatin by vein over 60 minutes followed by TAS-106 by vein over 24 hours.
Drug: TAS-106
Starting dose of TAS-106 2.0 mg/m^2 administered by vein over 24 hours, Day 1 of 3 Week Cycle
Drug: Carboplatin
Escalating doses, starting target AUC of carboplatin is 4, administered at each individual dose level by vein over 60 minutes, Day 1 of 3 Week Cycle

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of a solid tumor. Advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy exists
  2. Objective evidence or disease recurrence or metastatic disease
  3. Age >/= 18 years old at study entry
  4. Measurable or evaluable disease
  5. A score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
  6. Hemoglobin > 9.0 g/dL; Platelet count >/=100,000/uL; Absolute neutrophil count (ANC) >/=1500/uL
  7. Serum creatinine </=1.5 mg/dL; if > 1.5mg/dL, then a calculated creatinine clearance must be >/=60 mL/min
  8. Total bilirubin </=1.5 mg/dl; ALT </= 2 times the upper limit of normal (ULN) (may be </= 5 times ULN if due to metastatic disease in the liver).
  9. Fertile men and women, and their partners, must use a medically effective contraception method (spermicide with male or female condoms, cervical sponge, IUD, cervical cap, or diaphragm or oral, implantable, transdermal, or injectable contraceptives) throughout the treatment period and for 30 days after the last dose of study medication. Premenopausal women of reproductive capacity and women less than 12 months after menopause must have a negative pregnancy test documented prior to study entry.
  10. Signed written informed consent per institutional and federal regulatory requirements

Exclusion Criteria:

  1. Has known hypersensitivity to carboplatin
  2. Radiological or clinical evidence of brain involvement or leptomeningeal disease
  3. Have history of Human Immunodeficiency Virus, hepatitis B, or hepatitis C infection
  4. >/=grade 2 peripheral neuropathy
  5. Women who are pregnant or breast feeding.
  6. Serious illness or medical condition(s) including but not limited to the following: a) Congestive heart failure or uncontrolled angina pectoris. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or dysrhythmias. b) Active infection. c) Unstable diabetes mellitus. d) Psychiatric disorder that may interfere with consent and/or protocol compliance
  7. Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.
  8. Receiving concurrent chemotherapy, investigational agents radiotherapy, or surgery.
  9. Received radiation therapy to >30% of bone marrow (e.g., whole of pelvis or half of spine).
  10. Received any investigational drug within the last 30 days.
  11. Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752011

Contacts
Contact: Aung Naing, MD 713-563-0181

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Taiho Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Aung Naing, MD U.T. M.D. Anderson Cancer Center
  More Information

U.T. M.D. Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: U.T. M.D. Anderson Cancer Center ( Aung Naing, MD/Assistant Professor )
Study ID Numbers: 2007-0623
Study First Received: September 10, 2008
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00752011  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Solid Tumors
Carboplatin
TAS-106
Antitumor Activity
Pharmacokinetics

Study placed in the following topic categories:
Carboplatin

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009