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Phase Ib/IIa, Two-stage Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Gastric Adenocarcinoma

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Trial Information

Phase Ib/IIa, Two-stage Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients

This study is a two-stage design. Stage 1

The investigator should evaluate two recommend dose and tolerability of nab-paclitaxel plus
S-1 after one course of treatment as 3+1 design:

nab-paclitaxel should be given intravenously on days 1 and 8 at a dose as follows, Treatment
should be repeated every 3 weeks: Treatment arm A:125 mg /m2; Treatment arm B:100 mg /m2;
Treatment arm C: 80 mg /m2; S-1 should be given orally twice a day as follows for 14
consecutive days, followed by a 1-week rest. Treatment should be repeated every 3 weeks. BSA
< 1.5 m2,40mg,bid;BSA ≥ 1.5 m2,50mg,bid.

The investigator should determine whether to continue the original regimen; compare the
safety and pharmacokinetic results with original profile of combination therapy to select
the best therapy programs (RD, recommended dose).

Stage 2 According to two-stage design (Simon,1989), re-entry subjects to the recommended
dose group to a total of 25 valid cases. If 11 patients achieve response, then enter the
second phase of total 66 patients.

Inclusion Criteria:

1. Signed informed consent form

2. Age 18-75 years;

3. Histologically or cytologically confirmed gastric cancer;

4. Advanced or recurrent, metastatic disease;

5. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;

6. Life expectancy of at least 12 weeks;

7. At least have one measurable disease(according to RECIST, Response Evaluation
Criteria in Solid Tumors )

8. Subjects who have received one prior regimen for gastric carcinoma and developed
disease progression or recurrence within 6 months after the end of systemic adjuvant
treatment. The regimen must have contained fluorouracil(e.g. 5-FU,capecitabine)
and/or cisplatin;

9. Haematopoietic status:

- Absolute neutrophil count > 1.5 x 109/L,

- Platelet count > 90 x 109/L,

- Hemoglobin at least 9 g/dl,

10. Hepatic status:

- Bilirubin ≤ 1.5 x upper limit of normal (ULN),

- AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver

11. Renal status:

- Creatinine ≤1.5 times ULN or calculated creatinine clearance, using the
Cockcroft-Gault formula, ≥40 mL/min;

12. Able to swallow and retain oral medication;without malabsorption syndrome, or disease
significantly affecting gastrointestinal function, such as ulcerative colitis and
Crohn's disease;

13. Cardiovascular: Baseline LVEF 50% measured by echocardiography (ECHO) ;

14. Negative serum pregnancy test (For women of childbearing potential);Fertile patients
must use effective contraception.

Exclusion Criteria:

1. Received any prior treatment including taxane or S-1;

2. Concurrent systemic anti-cancer therapy (immunotherapy, biologic therapy, hormone
therapy, etc ); received treatment with an investigational agent or participation in
another therapeutic clinical trial within 4 weeks;

3. Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities
greater than grade 2; peripheral neuropathy of grade 2 or greater

4. Symptomatic brain metastasis;

5. Known history of uncontrolled or symptomatic angina, clinically significant
arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110),
unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen;

6. History of other malignancy. However, subjects with a past or current history of
completely resected basal and squamous cell carcinoma of the skin or successfully
treated in situ carcinoma of the cervix are eligible

7. Dementia, altered mental status, or any psychiatric condition that would prevent the
understanding or rendering of ICF;

8. Active or uncontrolled infection;

9. Concurrent treatment with an investigational agent or participation in another
therapeutic clinical trial;

10. Pregnant or lactating women.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

adverse events

Outcome Description:

participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Outcome Time Frame:

during the treatment in the hosptital,an expected average of 3 weeks

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

December 2012

Related Keywords:

  • Gastric Adenocarcinoma
  • advanced
  • resistant to prior chemotherapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms