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Gastric AdenocarcinomaPhase 1/2NCT01336062

Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients

A Phase 1/2 study testing Nanoparticle Albumin-Bound Paclitaxel in people with Gastric Adenocarcinoma, run by Peking University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Gastric cancer have poor prognosis and majority of patients resistant to 5-FU/DDP based first-line chemotherapy in China. There was no recommended second-line chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
Nanoparticle Albumin-Bound Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
Apr 2011to Dec 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form
  • Age 18-75 years;
  • Histologically or cytologically confirmed gastric cancer;
  • Advanced or recurrent, metastatic disease;
  • Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
  • Life expectancy of at least 12 weeks;
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  • At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
  • 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;
  • Haematopoietic status:
  • Absolute neutrophil count > 1.5 x 109/L,
  • Platelet count > 90 x 109/L,
  • Hemoglobin at least 9 g/dl,
  • 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 metastasis)
  • Renal status:
  • Creatinine ≤1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥40 mL/min;
  • Able to swallow and retain oral medication；without malabsorption syndrome, or disease significantly affecting gastrointestinal function, such as ulcerative colitis and Crohn's disease;
  • Cardiovascular: Baseline LVEF 50% measured by echocardiography (ECHO) ;
  • Negative serum pregnancy test (For women of childbearing potential);Fertile patients must use effective contraception.

Who cannot join

  • Received any prior treatment including taxane or S-1;
  • 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;
  • Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater
  • Symptomatic brain metastasis;
  • 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;
  • 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
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  • Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
  • Active or uncontrolled infection;
  • Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Lin Shen

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

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

Gastric cancer have poor prognosis and majority of patients resistant to 5-FU/DDP based first-line chemotherapy in China. There was no recommended second-line chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound Paclitaxel (Abraxane，ABI-007) has good convenience to use and been approved in breast cancer in many countries. The investigator then initiated a prospective phase Ib/IIa clinical trial with nab-paclitaxel plus TS-1 as the second-line treatment in advanced gastric cancer to observe the safety and efficacy.

Read the detailed description

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.

Being tested
Nanoparticle Albumin-Bound Paclitaxel
Keywords
advanced, resistant to prior chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nanoparticle Albumin-Bound PaclitaxelDrug

    this study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;

Study groups in NCT01336062
Study groupRoleWhat they receive
Nanoparticle Albumin-Bound PaclitaxelExperimentalThe study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;
Receives: Drug: Nanoparticle Albumin-Bound Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse events

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

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

  2. Objective response rate

    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

    Measured: 6 weeks

Secondary outcomes (3)

  1. progression free survival

    the follow-up visit of PFS will be performed every 6 weeks

    Measured: 1 year

  2. overall survival of participants

    OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost

    Measured: 2 years

  3. biomarkers

    If the tumour samples available, to identify the molecular characteristics(such as SPARK,ABCG2,β-Tubulin III,PDGFRA,etc) of responding tumours by immunohistochemical, FISH, genomic and proteomic analysis; To study biomarkers expression before and during therapy and establish correlations with clinical outcome and toxicity;

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01336062
Sponsor's protocol ID
NAB-PTX-GC
Status last verified
May 2015
First submitted
4 Apr 2011
Last updated
19 May 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nanoparticle Albumin-Bound Paclitaxel in people with Gastric Adenocarcinoma, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events (time frame: during the treatment in the hosptital,an expected average of 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01336062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.

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