Phase 1 Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C

Millennium Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Advanced Gastrointestinal Malignancies

Treatments: Drug: MLN0264

Study type: Interventional

Funder types: Industry

Identifiers

NCT01577758

U1111-1163-9720 (Registry Identifier)

C26001

2011-002260-24 (EudraCT Number)

Details and patient eligibility

About

This is an Open-Label, Multicenter, Dose Escalation, First-in-Human Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Response Evaluation Criteria in Solid Tumors (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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

MLN0264

Experimental group

Description:

MLN0264 starting dose 0.3 mg/kg escalated until Maximum Tolerated Dose (MTD) was determined, 30-minute infusion, on Day 1 of each 21-Day treatment cycle.

Treatment:

Drug: MLN0264