Phase 1
N=19
Phase 1 Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C
Advanced Gastrointestinal Malignancies
Bottom Line
View on ClinicalTrials.gov: NCT01577758 ↗Enrolled (actual)
19
Serious AEs
39.0%
Results posted
Jul 2016
Primary outcome: Primary: Number of Participants With Dose-Limiting Toxicities (DLTs) — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MLN0264 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicities (DLTs) |
0; 0; 0; 0; 1; 2 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events |
19; 25; 8; 9 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of MLN0264 |
1.8 | — |
| PRIMARY Cmax: Maximum Observed Serum Concentration for MLN0264 |
48.63 | — |
| PRIMARY Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE) |
7.91 | — |
| PRIMARY AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MLN0246 |
67.81 | — |
| PRIMARY AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MMAE |
51.90 | — |
| SECONDARY Best Overall Response |
0; 0; 6; 0; 6; 0 | — |
| SECONDARY Number of Participants With Antitherapeutic Antibodies (ATA) |
0; 0; 0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01577758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.