Phase I Study of TAS-106 in Combo With Carboplatin

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. Identifier: NCT00752011
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : October 18, 2012
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to find the 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.


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 or disease Intervention/treatment Phase
Cancer Solid Tumors Drug: TAS-106 Drug: Carboplatin Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors
Study Start Date : June 2008
Actual Primary Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Carboplatin + TAS-106
Carboplatin starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle. TAS-106 starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.
Drug: TAS-106
Starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.
Drug: Carboplatin
Starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle.
Other Name: Paraplatin

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: With every 3 week cycle ]

Secondary Outcome Measures :
  1. To review relationship between selected biomarkers and efficacy/safety outcomes. [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00752011

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Taiho Pharmaceutical Co., Ltd.
Principal Investigator: Aung Naing, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00752011     History of Changes
Other Study ID Numbers: 2007-0623
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012

Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors
Advanced Cancer
Antitumor Activity

Additional relevant MeSH terms:
Antineoplastic Agents