Phase I Study of TAS-106 in Combo With Carboplatin

NCT00752011 | Completed Phase 1

• 1 other identifier: 2007-0623
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Cancer; Solid Tumors

Keywords

Cancer; Solid Tumors; Advanced Cancer; Carboplatin; Paraplatin; TAS-106; Antitumor Activity; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  With every 3 week cycle

Secondary Outcomes (1)

• To review relationship between selected biomarkers and efficacy/safety outcomes.

  2 years

Study Arms (1)

Carboplatin + TAS-106

EXPERIMENTAL

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; Drug: Carboplatin

Interventions

TAS-106 DRUG

Starting dose 2.0 mg/m\^2 by vein over 24 hours, Day 1 of 3 Week Cycle.

Carboplatin + TAS-106

Carboplatin DRUG

Starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle.

Also known as: Paraplatin

Carboplatin + TAS-106

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Objective evidence or disease recurrence or metastatic disease
• Age \>/= 18 years old at study entry
• Measurable or evaluable disease
• A score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
• Hemoglobin \> 9.0 g/dL; Platelet count \>/=100,000/uL; Absolute neutrophil count (ANC) \>/=1500/uL
• Serum creatinine \</=1.5 mg/dL; if \> 1.5mg/dL, then a calculated creatinine clearance must be \>/=60 mL/min
• 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).
• 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.
• Signed written informed consent per institutional and federal regulatory requirements.

You may not qualify if:

• Has known hypersensitivity to carboplatin
• Radiological or clinical evidence of brain involvement or leptomeningeal disease
• Have history of Human Immunodeficiency Virus, hepatitis B, or hepatitis C infection
• \>/=grade 2 peripheral neuropathy
• Women who are pregnant or breast feeding.
• 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
• Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.
• Receiving concurrent chemotherapy, investigational agents radiotherapy, or surgery.
• Received radiation therapy to \>30% of bone marrow (e.g., whole of pelvis or half of spine).
• Received any investigational drug within the last 30 days.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• U.T. M.D. Anderson Cancer Center website

MeSH Terms

Conditions

Neoplasms

Interventions

1-(3-C-ethynylribopentofuranosyl)cytosine; Carboplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Aung Naing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 12, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2012
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

US (1)