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Gastric CancerPhase 2NCT01956149

Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer

A Phase 2 study testing Cabazitaxel in people with Gastric Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 3 sites in Germany.

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

Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Cabazitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
3 sitesGermany
Study dates
Sep 2013to 4 Apr 2018
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach
  • Progression of a measurable lesion (RECIST) on previous palliative chemotherapy. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs < 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line.
  • Male and female patients aged > 18 years
  • ECOG ≤ 1
  • neutrophils ≥ 1500/µl
  • Haemoglobin ≥ 9 g/dl
Show all 11Show fewer
  • Platelets ≥ 100,000/µl
  • AST/SGOT and/or ALT/SGPT ≤2.5 x ULN;
  • Total bilirubin ≤1.0 x ULN
  • Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min
  • Written patient informed consent

Who cannot join

  • A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3)
  • Active CAD, cardiomyopathy or NYHA stage III-IV heart failure
  • Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)
  • Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection
  • Concomitant medication or planned treatment with strong CYP450 3A4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment
  • Peripheral polyneuropathy > NCI grade II
Show all 10Show fewer
  • Severe hepatic impairment (AST/ALT > 2.5 x ULN, , bilirubin > 1 x ULN)
  • Chronic inflammatory bowel disease
  • Participation in another study
  • Pregnancy or lactation

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Krankenhaus Dresden Friedrichstadt

    Dresden

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

  • Universitätsklinikum Jena

    Jena, 07747

Other trials in Germany

About this study

Official title: Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach

Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.

Read the detailed description

65 patients with advanced or metastatic adenocarcinoma of the oesophagogastric junction and stomach will be treated with 20mg/m2 Cabazitaxel for a maximum of 6 cycles. Main objective of the study is the Disease Control Rate (DCR) with Cabazitaxel.

Conditions
Gastric Cancer
Being tested
Cabazitaxel
Keywords
gastric cancer, second-line treatment, Cabazitaxel, response
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • CabazitaxelDrug

    20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.

Study groups in NCT01956149
Study groupRoleWhat they receive
CabazitaxelExperimentalCabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22
Receives: Drug: Cabazitaxel

What is being measured

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

  1. Disease Control Rate (DCR)

    Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)

    Measured: up to 17 months

Secondary outcomes (6)

  1. Overall survival (OS)

    From date of randomization until the date of death from any cause, assessed up to 17 months

    Measured: up to 17 months

  2. Progression-free survival (PFS)

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 17 months

    Measured: up to 17 months

  3. Response rate by subgroup (with and without previous treatment with a taxane)

    Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)

    Measured: up to 17 months

  4. Toxicity

    incidence and intensity of adverse events

    Measured: up to 18 weeks

  5. Correlation of circulating tumor cells with PFS and OS

    samples for analysis of circulating tumor cells are taken before therapy, before every new cycle, and at the end of treatment (every 3 weeks).

    Measured: up to 18 weeks

  6. Correlation of circulating tumor cells with the clinical response

    Measured: up to 18 weeks

Timeline

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

  1. First posted8 Oct 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2017
  4. Study completion4 Apr 2018

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01956149
Sponsor's protocol ID
CabaGast
Status last verified
Jan 2018
First submitted
3 Jul 2013
Last updated
18 Apr 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabazitaxel in people with Gastric Cancer, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 3 sites in Germany.

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 11 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. 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 phase mean?

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?

Disease Control Rate (DCR) (time frame: up to 17 months). 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 NCT01956149.

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 18 Apr 2018; AzTrials last refreshed its copy on 2 Nov 2026.

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