Phase I Study of TAS-106 in Combo With Carboplatin

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Taiho Pharmaceutical Co., Ltd.
• Treatments: Carboplatin

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 creatinine1.5mg/dL, then a calculated creatinine clearance must be >/=60 mL/min

8. Total bilirubin

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.