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Adenocarcinoma of the StomachPhase 2NCT01095120

Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer

A Phase 2 study testing Tesetaxel in people with Adenocarcinoma of the Stomach and Adenocarcinoma of Esophagogastric Junction, run by Genta Incorporated at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tesetaxel
How many people
27 participants
Where
4 sitesin 2 countries
Study dates
Mar 2010to Oct 2012
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

Primary inclusion criteria:

  • Confirmed diagnosis of adenocarcinoma of the stomach or esophagogastric junction
  • Measurable disease (revised RECIST; Version 1.1) based on computed tomography
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Treatment with only 1 prior regimen (as first-line therapy) and that regimen included a fluoropyrimidine and/or a platinum analogue
  • Documented disease progression within 4 months of the last dose of the 1 prior regimen
  • Adequate bone marrow, hepatic, and renal function, as defined in the protocol
  • At least 4 weeks and recovery from effects of prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy, with an approved or investigational agent
  • Ability to swallow an oral solid-dosage form of medication

Primary exclusion criteria:

  • Nonmeasurable disease only (revised RECIST; Version 1.1)
  • History or presence of brain metastasis or leptomeningeal disease
  • Operable gastric cancer or operable cancer of the esophagogastric junction
  • Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the patient's usual number of bowel movements on at least 2 days within the 14 days prior to enrollment
  • Uncontrolled nausea or vomiting within the 14 days prior to enrollment despite the administration of standard antiemetic therapy
  • Known malabsorptive disorder
  • Significant medical disease other than cancer, as defined in the protocol
  • Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; Version 4.0)
  • Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
  • Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • The University of Texax MD Anderson Cancer Center

    Houston, Texas, 77030

  • Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

Other trials in United States

South Korea1 site

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

Other trials in South Korea

About this study

Official title: A Phase II Study of Tesetaxel Administered at a Flat Dose Once Every 21 Days as Second-line Therapy to Subjects With Advanced Gastric Cancer

Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer.

Being tested
Tesetaxel

What participants receive

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

  • TesetaxelDrug

    Also called DJ-927

    For subjects in Cohort A, a flat dose of 40 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the Cycle 1 flat dose may be increased by 5 mg in Cycle 2, and the Cycle 2 flat dose may again be increased by 5 mg in Cycle 3.

    For subjects in Cohort B, a flat dose of 50 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the dose may be increased by 10 mg in Cycle 2.

    For subjects in Cohort C, a dose of 27 mg/m2 will be administered in Cycle 1. In subsequent cycles, depending on tolerability, the dose will be increased to 35 mg/m2 in Cycle 2.

What is being measured

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

  1. Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))

    Measured: 12 months from date of first dose of study medication

Secondary outcomes (4)

  1. Disease control rate (ie, the percentage of patients with a confirmed complete or partial response [of any duration] or stable disease at least 6 weeks in duration)

    Measured: 12 months from date of first dose of study medication

  2. Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)

    Measured: 12 months from date of first dose of study medication

  3. Duration of response

    Measured: 12 months from date of first dose of study medication

  4. Adverse events

    Measured: Through 30 days post last dose of study medication

Timeline

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

  1. First posted29 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionSep 2012 (estimated)
  4. Study completionOct 2012 (estimated)

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
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01095120
Sponsor's protocol ID
TOG201
Status last verified
Mar 2012
First submitted
26 Mar 2010
Last updated
15 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tesetaxel in people with Adenocarcinoma of the Stomach and Adenocarcinoma of Esophagogastric Junction, run by Genta Incorporated at 4 sites in 2 countries.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, South Korea. 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?

Results are not available in the source record.

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?

Response rate (Response Evaluation Criteria In Solid Tumors (RECIST)) (time frame: 12 months from date of first dose of study medication). 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 NCT01095120.

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 15 Mar 2012.

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