Phase I Study of TAS-106 in Combo With Carboplatin

This study has been completed.
Sponsor:
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00752011
First received: September 10, 2008
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.

Objectives:

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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors

Resource links provided by NLM:


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

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

Enrollment: 45
Study Start Date: June 2008
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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: NCT00752011

Locations
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.
Investigators
Principal Investigator: Aung Naing, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00752011     History of Changes
Other Study ID Numbers: 2007-0623
Study First Received: September 10, 2008
Last Updated: October 16, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carboplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014