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A Phase I Study of TS-1, Cisplatin & RAD001 (Everolimus)

Phase 1
21 Years
80 Years
Not Enrolling

Thank you

Trial Information

A Phase I Study of TS-1, Cisplatin & RAD001 (Everolimus)

Inclusion Criteria:

- Histologically documented locally advanced, metastatic or recurrent solid
malignancies that are refractory to standard therapy, for which convention therapy is
not effective or platinum/fluoropyrimidine is indicated.

- At least one measurable or evaluable disease defined by RECIST

- Age >21 years old

- Performance status (ECOG) 0-2

- Life expectancy >3 months

- No significant problems for oral intake and drug administration

- Adequate organ functions:

- bone marrow function (ANC ≥ 1,500/uL, Platelet ≥ 100,000/ uL, Hb ≥ 9.0 g/dl)

- renal function: serum creatinine ≤ UNL (if serum creatinine > ULN, creatinine
clearance should be ≥ 60 mL/min)

- hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x ULN without
liver metastasis, total bilirubin < 3x ULN and AST/ALT levels < 5 x ULN with
liver metastasis)

- Prior systemic therapy (eg, cytotoxic chemotherapy or biologic therapy) and major
surgery are allowed if at least 28 days has elapsed between completion of therapy and
administration of study drugs

- Ability to understand and willingness to sign a written informed consent before study

Exclusion Criteria:

- Failure to recover from the reversible effects of previous chemotherapy,
radiotherapy, hormonal, or biologic therapy prior to enrollment

- Second primary malignancy (except in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin or prior malignancy treated more than 5
years ago without recurrence)

- Prior radiotherapy was administered to target lesions selected for this study, or
radiotherapy to the non-target lesions has been completed within 4 weeks before

- Prior mTOR inhibitor

- Presence of symptomatic or progressing CNS metastasis

- Serious illness or medical conditions:

- Congestive heart failure (NYHA class III or IV), unstable angina or myocardial
infarction within the past 12 months

- Significant arrhythmias requiring medication and conduction abnormality such as
over 2nd degree AV block

- Uncontrolled hypertension

- Hepatic cirrhosis (≥ Child class B)

- Interstitial pneumonia

- Psychiatric disorder that may interfere with protocol compliance

- Unstable diabetes mellitus

- Uncontrolled ascites or pleural effusion

- Active infection

- Receiving a concomitant treatment interacting with TS-1, cisplatin or RAD001.
Flucytosine (a fluorinated pyrimidine antifungal agent) Antivirals such as
sorivudine, ramivudine, brivudine or other chemically related agents, warfarin,
phenprocoumon, phenytoin, allopurinol, immunosuppressive agents. Strong and
moderate inhibitors or inducers of P-glycoprotein, CYP3A4 and CYP3A5 (appendix
A) are not eligible; a minimal of 2 weeks wash- out period will be required
after stop such medications

- Known hypersensitivity to TS-1, CDDP or mTOR inhibitor.

- Pregnant or lactating woman. Women of child bearing potential not using a
contraceptive method

- Sexually active fertile men not using effective birth control during medication of
study drug and up to 6 months after completion of study drug if their partners are
women of child-bearing potential

- Any patients judged by the investigator to be unfit to participate in the study

Type of Study:


Study Design:


Principal Investigator

Wei Peng Yong, MRCP, MB ChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Cancer
  • The purpose of the study is to evaluate the safety and feasibility of combining TS-1/CDDP with RAD001. Primary
  • Objectives
  • To determine the MTD/recommended phase II dose of TS-1/CDDP/RAD001 combination —To determine
  • the safety of TS-1/CDDP/RAD001 combination Secondary Objectives —To preliminarily describe any clinical activity in
  • platinum refractory disease
  • To assess to effect of concurrent TS-1/CDDP on RAD001 pharmacokinetics —To explore
  • the relationship of tumour biomarkers and treatment response