A study of TAS-120 in patients with advanced cancer with or without genetic abnormalities
- Conditions
- Advanced solid tumors and multiple myelomaMedDRA version: 16.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 16.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004810-16-ES
- Lead Sponsor
- Taiho Pharma USA, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 835
1. Provide written informed consent.
2. Age of 18 years or over.
3. Phase 1 Dose Escalation:
Patients with histologically or cytologically confirmed advanced, measurable or non-measurable (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] guidelines [version 1.1, 2009]) metastatic solid tumor(s) who have failed all standard therapies or for whom standard therapy does not exist. Starting with Dose Level 5 of each dosing schedule, only patients with locally diagnosed amplification, mutation, translocation or other associated abnormalities of FGF/FGFR will be enrolled (see Section 8.12, Pharmacogenomic (FGF/FGFR) Analysis).
6. Able to take medications orally (eg, no feeding tube).
7. Adequate organ function as defined by the following criteria:
a. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST and ALT <= 5 × ULN.
b. Total serum bilirubin <= 1.5 × ULN.
c. Absolute neutrophil count >= 1 500/mm3 (ie, >= 1.5 × 109/L by International Units [IU]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF]).
d. Platelet count >= 100 000/mm3 (IU: >= 100 × 109/L) (excluding measurements obtained within 7 days after a transfusion of platelets).
e. Hemoglobin >= 8.0 g/dL (excluding measurements within 4 weeks of a transfusion of packed red blood cells [RBCs] or whole blood).
f. Serum Phosphorus <= ULN
g. Serum Calcium <= ULN
8. Creatinine < 1.5 × ULN.
9. Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to administration of the first dose of TAS-120. Both males and females of reproductive potential must agree to use adequate birth control during the study and for 6 months after the last dose of TAS-120. Female patients are not considered to be of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 1 year without menses.
Phase 1 Expansion and Phase 2:
Patients with histologically or cytologically confirmed advanced, measurable (as defined by RECIST guidelines [version 1.1, 2009]), metastatic solid tumor(s) or multiple myeloma (with measurable disease as defined by International Myeloma Working Group [IMWG] criteriaFGF/FGFR for whom no available therapy is likely to convey clinical benefit.
Patients with multiple myeloma can be enrolled provided they have measurable disease as defined by at least 1 of the following criteria:
? Serum protein electrophoresis (SPEP) >= 1 g/dL of monoclonal protein in serum.
? Urine protein electrophoresis (UPEP) > 200 mg of monoclonal protein in urine (based on 24-hour urine).
? Serum free light chain (SFLC): involved free light chain (FLC) >= 10 mg/dL (>= 100 mg/L) AND abnormal kappa to lambda SFLC ratio.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 335
1. History and/or current evidence of endocrine alteration of calcium-phosphorus homeostasis.
2. History and/or current evidence of ectopic mineralization/calcification including but not limited to soft tissue, kidneys, intestine, or myocardia and lung with the exception of calcified lymph nodes and asymptomatic arterial calcification.
3. Current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuctivitis, etc, confirmed by ophthalmologic examination.
5.QTc > 470 msec on ECG conducted during Screening period
6. Treatment with any of the following within the specified time frame prior to the first dose of TAS-120:
a. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of TAS-120).
b. Radiotherapy for extended field within 4 weeks prior to the first dose of TAS-120 or limited field radiotherapy within 2 weeks prior to the first dose of TAS-120.
c. Any noninvestigational anticancer therapy within 3 weeks prior to TAS-120 administration (mitomycin within prior 5 weeks).
d. Any medication administered within 7 days prior to first dose of TAS-120 that is known to affect QT interval or to be arrhythmogenic such as, but not limited to, the following drugs (http://creciblemeds.org/pdftemp/pdf/CompositeList.pdf):
i. Ondansetron
ii. Erythromycin
iii.Droperidol
iv. Halofantrine
e. Any investigational agent received either concurrently or within the previous 30 days.
7. A serious illness or medical condition(s) including, but not limited to, the following:
a. Known brain metastasis unless patient is clinically stable and off corticosteroids for >= 2 months.
b. Known leptomeningeal metastasis.
c. Known acute systemic infection.
d. Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV (see Appendix B, New York Heart Association [NYHA] Classification) within the previous 6 months; if > 6 months cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms.
e. Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the investigator.
f. Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness, or a history of serum positivity to hepatitis B or C.
g. Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death.
h. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or TAS-120 administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
8. Pregnant or lactating female.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method