Know Cancer

or
forgot password

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Gastrointestinal Malignancies

Thank you

Trial Information

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C


Inclusion Criteria:



- Voluntary consent form

- Diagnosis of GI malignancy with a GCC protein expressing tumor

- Male or female patients 18 years or older with measurable disease as defined by
RECIST

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception or agree to abstain from heterosexual intercourse

- Male patients who agree to practice effective barrier contraception or agree to
abstain from heterosexual intercourse

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate bone marrow, hepatic and renal function as specified in the protocol

Exclusion Criteria:

- Female patients who are lactating or have a positive serum pregnancy test during the
screening period

- Any serious medical or psychiatric illness that could interfere with the completion
of treatment

- Major surgery or treatment with investigational drug before the first dose

- Serious infection within 14 days before the first dose of study drug

- Known HIV, inflammatory bowel disease, viral hepatitis or cerebral/meningeal brain
metastases

- Patients with cardiovascular conditions specified in protocols

- Patients with history of another primary malignancy not in remission for at least 3
years

Please note that there are additional inclusion and exclusion criteria. The study center
will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if
you do qualify for the study. You can then decide whether or not you wish to participate.
If you do not qualify for the trial, site personnel will explain the reasons.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Dose-limiting toxicities (DLTs), adverse events, serious adverse events, assessment of clinical laboratory values and vital sign measurements

Outcome Description:

To assess the safety profile, including DLTs, of MLN0264

Outcome Time Frame:

From the time informed consent is signed through 30 days after the last dose of study drug, approximately 36 to 42 months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C26001

NCT ID:

NCT01577758

Start Date:

June 2012

Completion Date:

March 2015

Related Keywords:

  • Advanced Gastrointestinal Malignancies
  • Phase 1,
  • Advanced gastrointestinal malignancies,
  • MLN0264,
  • Guanylyl Cyclase C(GCC),
  • Antibody Drug Conjugate(ADC)
  • Neoplasms

Name

Location

Moffitt Cancer CenterTampa, Florida  33612