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A Phase II Trial of RAD001 (Everolimus) for 2nd Line Treatment After Failure of Fluoropyrimidine Plus Platinum Chemotherapy in Patients With Metastatic or Recurrent Gastric Cancer With pS6 Ser 240/4 Expression


Phase 2
20 Years
75 Years
Open (Enrolling)
Both
Stomach Neoplasm

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Trial Information

A Phase II Trial of RAD001 (Everolimus) for 2nd Line Treatment After Failure of Fluoropyrimidine Plus Platinum Chemotherapy in Patients With Metastatic or Recurrent Gastric Cancer With pS6 Ser 240/4 Expression


Methodology: Prospective, non blinded, open label, single center phase II study

Criteria for evaluation: Assessment of response will be assessed radiologically according to
RECIST criteria after completion of the two cycles. Evaluation will be by physical
examination, chest X-ray, abdomen-pelvis CT scan Safety criteria: Physical examination,
vital signs, performance status, CBC, serum chemistry, NCI CTC V.3.0


Inclusion Criteria:



- histologically or cytologically documented stomach adenocarcinoma including
adenocarcinoma of the esophagogastric junction

- non-resectable disease by metastasis or recurrent disease after curative surgical
resection (See Appendix A) with uni-dimensionally measurable disease

- failure of 1st line chemotherapy including fluoropyrimidine (capecitabine, S1, or
5-FU,) and platinum (cisplatin or oxaliplatin) in palliative setting; progression
during or within 6 months after chemotherapy

- High expression of pS6 Ser 240/4 (proportion of pS6 Ser 240/4 positive cancer cells
by immunohistochemistry > 10%)

- Age 20 to 75 years old

- Estimated life expectancy of more than 3 months

- ECOG performance status of 2 or lower

- Adequate bone marrow function

- Adequate kidney function

- Adequate liver function

- Fasting serum cholesterol ≤ 300 mg/dL AND fasting triglyceride ≤ 2.5 X ULN

- No prior radiation therapy to more than 25% of BM

- psychological, familial, sociological or geographical conditions which do not permit
medical follow-up and compliance with this study

- Women of childbearing potential must have a negative pregnancy test on admission

- Written informed consent

Exclusion Criteria:

- Other tumor type than adenocarcinoma

- CNS metastases or prior radiation for CNS metastases

- Gastric outlet obstruction or intestinal obstruction

- Evidence of active gastrointestinal bleeding

- Bone lesions as the sole evaluable disease

- Past or concurrent history of neoplasm other than stomach cancer

- Pregnant or lactating women, women of childbearing potential not employing adequate
contraception

- Other serious illness or medical conditions

- Concomitant or with a 4-week period administration of any other experimental drug
under investigation

- Concomitant chemotherapy, hormonal therapy, or immunotherapy

- Any preexisting medical condition of sufficient severity to prevent full compliance
with the study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

4-month progression-free survival

Outcome Description:

Progression-free survival is defined as the time from the first treatment to the onset of progressive disease per RECIST criteria or to the date of death whichever comes first. For patients who do not experience progressive disease or death, the progression-free survival duration will be right censored on the last disease assessment date.

Outcome Time Frame:

up to 3years

Safety Issue:

No

Principal Investigator

Yoon-Koo Kang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

AMC1103

NCT ID:

NCT01482299

Start Date:

November 2011

Completion Date:

August 2013

Related Keywords:

  • Stomach Neoplasm
  • pS6 Ser 240/4
  • RAD001 (everolimus)
  • second-line treatment
  • advanced gastric cancer
  • Neoplasms
  • Stomach Neoplasms

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