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Stomach NeoplasmsPhase 2NCT00620607

huC242-DM4 Treating Patients With Metastatic Gastric or Gastroesophageal Junction Carcinomas

A Phase 2 study testing huC242-DM4 in people with Stomach Neoplasms and Metastatic or Locally Advanced Gastric Cancer, run by ImmunoGen, Inc. at 4 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To assess the response rate of huC242-DM4 given as an intravenous infusion to patients with metastatic or locally advanced gastric or gastroesophageal junction cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
huC242-DM4
Type of treatment
Injection or infusion
How many people
0 participants
Where
4 sitesUnited States
Study dates
May 2007to Sep 2010
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

  • Patients must understand and voluntarily sign an informed consent.
  • Patients must have histological documentation of metastatic or locally advanced (American Joint Committee on Cancer Staging System: Stages IIIA, IIIB, and IV) gastric or gastroesophageal junction adenocarcinoma.
  • Patients must have ECOG performance status < 1.
  • Patients must be at least 18 years of age.
  • Patients who have been treated with only one prior chemotherapy regimen and who have documented disease progression.
  • Patients must have confirmation of CanAg expression performed prior to enrollment by immunohistochemical assessment for CanAg on archived biopsy samples.
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  • Patients must have measurable disease with at least one lesion that can be accurately measured by Response Evaluation Criteria in Solid Tumors (RECIST). The lesion size must be at least 20 mm by conventional radiological techniques or at least 10 mm by spiral CT scan. Disease in an irradiated field as the only site of measurable disease is acceptable if there has been a clear progression of the lesion.
  • Patients with reproductive potential must agree to use an effective contraceptive method during the study and for 30 days after receiving the last dose of study drug.
  • Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within one week prior to enrollment in the study.
  • Patients must have any chemotherapy, immunotherapy, hormonal therapy, radiotherapy for cancer or surgery (except for minor surgical procedures) completed at least 3 weeks before starting study medication.
  • Patients must have resolution of all clinically significant toxic effects (excluding alopecia) of any prior treatments including surgery, radiotherapy, hormone therapy, immunotherapy, targeted non-cytotoxic therapy, or chemotherapy to grade ≤ 1 by NCI CTCAE v. 3.0 unless otherwise specified in the inclusion laboratory values.
  • Patients must have adequate organ function including:
  • Hematopoietic:
  • Absolute neutrophil count > 1,500/mm3. ii. Platelet count > 100,000/mm3. iii. Hemoglobin > 9 g/dL (transfusion allowed).
  • Renal:
  • Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) ii. Calculated creatinine clearance > 60 mL/min/1.73m2.
  • Hepatic:
  • Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 2.5 x ULN ii. Total bilirubin ≤ 1.5 x ULN

Who cannot join

  • Pregnant or lactating women. Women of childbearing potential (WCBP) must have a negative urine or blood test for pregnancy before first treatment.
  • Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids.
  • Active and uncontrolled infection.
  • Known history hepatitis B or C, HIV, or history of alcoholic liver disease.
  • Patients with any serious medical or psychiatric disorder that would interfere with patient safety or informed consent.
  • Patients with peripheral neuropathy grade 2 or greater.
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  • Patients with known leptomeningeal disease or progressive brain metastasis. Routine screening with CNS imaging studies (CT or MRI) is required only if clinically indicated.
  • Patients with concomitant malignancies or previous malignancies with less than a 2 year disease free interval at the time of dosing. Patients with adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low-grade prostate cancer may enroll irrespective of the time of diagnosis.
  • Patients who are receiving concomitant chemotherapy, immunotherapy, radiotherapy, or investigational therapy. Radiotherapy for palliation of related bone metastases is permitted upon the agreement between the investigator and the ImmunoGen Medical Monitor and as long as radiation does not involve target lesions that are followed for drug treatment response evaluation.
  • Patients with any severe concurrent disease or condition, which in the judgment of the Investigator, would make the patient inappropriate for study participation. The disease or condition include, but are not limited to, one or more of the following: bleeding diathesis, uncontrolled chronic kidney or liver disease, uncontrolled diabetes, history of cardiac disease, myocardial infarction within the past 6 months, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and uncontrolled hypertension.
  • Patients who must use contact lenses and cannot discontinue use of their contact lenses during the course of the clinical study. Patients must discontinue use of contact lenses prior to receiving study drug.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • U.T. M.D. Anderson Cancer Center

    Houston, Texas

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas

Other trials in United States

About this study

Official title: A Phase II, Open Label, Multiple Center Study of huC242-DM4 Given as an Intravenous Infusion Once Every Three Weeks to Patients With Metastatic Gastric or Gastroesophageal Junction Carcinomas

To assess the response rate of huC242-DM4 given as an intravenous infusion to patients with metastatic or locally advanced gastric or gastroesophageal junction cancer.

Being tested
huC242-DM4
Keywords
gastric
Medical subject headings
Stomach Neoplasms, Neoplasm Metastasis

What participants receive

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

  • huC242-DM4Drug

    dose of 126 mg/m2 or 168 mg/m2 given as IV once every 3 weeks

What is being measured

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

  1. response rate

    Measured: year

Secondary outcomes (5)

  1. duration of response

    Measured: as necessary

  2. progression free survival

    Measured: as necessary

  3. safety and tolerability

    Measured: while on study

  4. Pharmacokinetic (PK) assessment

    Measured: while on study

  5. effect of huC242-DM4 on tumor uptake of FDG

    Measured: while on study

Timeline

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

  1. First posted21 Feb 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionMay 2010 (estimated)
  4. Study completionSep 2010 (estimated)

Why it stopped: Lack of accrual

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00620607
Sponsor's protocol ID
IMGN 102
Status last verified
Apr 2009
First submitted
7 Feb 2008
Last updated
26 Aug 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing huC242-DM4 in people with Stomach Neoplasms and Metastatic or Locally Advanced Gastric Cancer, run by ImmunoGen, Inc. at 4 sites in United States.

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 18 inclusion and 11 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: withdrawn, as of the sponsor's last update on 26 Aug 2015. 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. 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 was withdrawn before enrolling participants, so there are no results.

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 (time frame: year). 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 NCT00620607.

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 26 Aug 2015.

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