AzTrials
AzTrials

Solid TumorPhase 1NCT00721669

A Phase I Dose-Escalation Study of IMGN388 in Patients With Solid Tumors

A Phase 1 study testing IMGN388 in people with Solid Tumor, run by ImmunoGen, Inc. at 3 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

Primary objective is to evaluate the safety and PK of IMGN388 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
IMGN388
How many people
60 participants
Where
3 sitesUnited States
Study dates
Jun 2008to Dec 2012
Phase
Phase 1
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

  • Male or female age greater than 18 years
  • Signed informed consent(s): Patients must provide informed consent for study participation prior to performing any study-specific procedures
  • Histologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
  • Specifically for the dose expansion phase, enrollment will be limited to patients with αv integrin positive melanomas or carcinomas of breast, lung, or ovary. Patients must also have confirmation of αv integrin expression performed prior to enrollment by immunohistochemical assessment for αv integrin on archived or if not available, freshly collected tumor biopsy samples. αv integrin positive tumors are defined as having a staining intensity of at least 2+ and a staining uniformity of heterogeneous (25 - 75% of tumor cells stain positively for αv integrin) or homogeneous staining (>75% of tumor cells are positive for αv integrin) of tumor cells when evaluated by immunohistochemistry .
  • Evidence of measurable or evaluable metastatic disease at baseline
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of less than or equal to 2
Show all 17Show fewer
  • Adequate bone marrow, liver, and renal function at the time of first dose of study agent, as described below:
  • Hemoglobin greater than or equal to 9.0 g/dL (5.6 mmol/L; 90 g/L) without transfusion dependency
  • Absolute neutrophil count (ANC)greater than or equal to 1.5 x 109/L (1500/mm3) without hematopoietic cytokine support
  • Platelets greater than or equal to 100,000 x 109/L (100,000/mm3) without transfusion dependency
  • Coagulation [prothrombin time (PT) or international normalized ratio (INR) and activated partial prothrombin time (aPTT)] ≤ 1.25 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN if no liver metastasis; ≤ 5 x ULN if liver metastasis
  • Total Bilirubin ≤ 1.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN
  • Female patients must be postmenopausal (at least 12 months since last menses), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before study entry, for the duration of study participation, and for three months after the last infusion of study agent and must have a negative urine or serum pregnancy test within 1 week before beginning treatment on this study and at all specified timepoints throughout the study. Men must be sterilized or agree to use a double-barrier method of birth control and must agree to not donate sperm during the study and for three months after the last infusion of study agent.
  • Able to adhere to study visit schedule and all protocol requirements
  • The anticipated life expectancy is such that the patient is expected to be able to participate for the duration of the study

Who cannot join

  • Patients meeting any of the following criteria may not be enrolled in the study:
  • Residual toxicities resulting from previous therapy that are ≥ Grade 1
  • Neuropathy of > Grade 1
  • History of uveitis within 6 months of first dose of study agent or presenting with uveitis at baseline
  • Concomitant or prior malignancy (other than the one under study) except adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Patients with solid tumors with history of active bleeding
Show all 18Show fewer
  • Treatment with systemic cancer therapy, radiotherapy or any investigational agent within 4 weeks or five half-lives (whichever is longer) of first dose of study agent
  • Known allergies or clinically important reactions to human proteins or to therapeutic antibodies
  • Major surgery within 4 weeks of first dose of study agent, or planning to have surgery (except for minor surgical procedures) during the study, or planned major surgery within 8 weeks after the last dose of study agent
  • Serious concurrent illness (medical or psychiatric), altered mental status (e.g., dementia) or any uncontrolled medical condition (eg, uncontrolled diabetes), including the presence of laboratory abnormalities, that would place the patient at unacceptable risk by participating in the study or would confound the ability to interpret data from the study
  • Uncontrolled infection, clinically important active infection within 4 weeks before the first dose of study agent, or currently receiving treatment for an infection
  • Active angina pectoris or New York Heart Association (NYHA) Class III or IV heart disease. Cardiac disease characterized by significant ischemic coronary disease, significant arrhythmias, or congestive heart failure (greater than NYHA Class II) or myocardial infraction within the past 6 months
  • Known or symptomatic central nervous system (CNS) metastases
  • Known to be seropositive for human immunodeficiency virus (HIV), or active Hepatitis A, B, or C infection
  • Any other concomitant anti-cancer treatment such as immunotherapy, biotherapy, radiotherapy, chemotherapy, investigative therapy, or high-dose steroids; however, low-dose steroids and Luteinizing Hormone Releasing Hormone (LHRH) at doses that have been stable for ≥ 14 days are permitted for patients with prostate cancer
  • Any medical condition that, in the opinion of the investigator, may compromise the safety of the patient or their ability to receive study treatment
  • Pregnant or lactating women
  • Patients will continue to be followed for short term follow-up and long term survival.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Sarah Cannon Research Institute

    Nashville, Tennessee

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Primary objective is to evaluate the safety and PK of IMGN388

Read the detailed description

The secondary objectives are to assess the pharmacodynamics, immunogenicity, and tumor response of IMGN388 administered as an IV infusion once every three weeks in patients with solid tumors

Conditions
Solid Tumor
Being tested
IMGN388
Keywords
solid tumor

What participants receive

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

  • IMGN388Drug

    IMGN388 is a human IgG1 anti-integrin antibody conjugated to the maytansinoid, DM4.

What is being measured

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

  1. evaluate the safety

    Measured: during study

  2. evaluate pharmacokinetics

    Measured: during study

Secondary outcomes (3)

  1. assess the pharmacodynamics

    Measured: during study

  2. assess immunogenicity

    Measured: during study

  3. assess tumor response

    Measured: during study

Timeline

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

  1. First posted24 Jul 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionOct 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00721669
Sponsor's protocol ID
IMGN388
Status last verified
Sep 2013
First submitted
22 Jul 2008
Last updated
13 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMGN388 in people with Solid Tumor, run by ImmunoGen, Inc. at 3 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 17 inclusion and 18 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 13 Sep 2013. 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 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 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.

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?

evaluate the safety (time frame: during study). 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 NCT00721669.

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 13 Sep 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in