Advanced Gastrointestinal MalignanciesPhase 1NCT01577758

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

A Phase 1 study testing MLN0264 in people with Advanced Gastrointestinal Malignancies, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.

Completed

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

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Gastrointestinal Malignancies
What is being tested?: MLN0264
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Feb 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

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

Show all 9Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Moffitt Cancer Center
Tampa, Florida, 33612

Other trials in United States

About this study

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

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.

Conditions: Advanced Gastrointestinal Malignancies
Being tested: MLN0264
Keywords: Phase 1,, Advanced gastrointestinal malignancies,, MLN0264,, Guanylyl Cyclase C(GCC),, Antibody Drug Conjugate(ADC)

What participants receive

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

MLN0264Drug
MLN0264 30-minute infusion on Day 1 of each treatment cycle

Study groups in NCT01577758
Study group	Role	What they receive
MLN0264	Experimental	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. Receives: Drug: MLN0264

What is being measured

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

Number of Participants With Dose-Limiting Toxicities (DLTs)
DLT was defined as any of the following Adverse Events (AEs) that occur and are considered by the investigator to be related to therapy.
1. Grade 4 neutropenia (Absolute Neutrophil Count < 500 cells/mm^3).
2. Grade 3 or greater neutropenia with fever and/or infection.
3. Grade 4 thrombocytopenia (platelets < 25,000/mm^3).
4. Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time.
5. Grade 3 or greater nausea and/or emesis that occurs despite of prophylaxis.
6. Grade 3 or greater diarrhea that occurs despite supportive care.
7. Any other Grade 3 or greater non-hematological toxicity other than Grade 3 fatigue or Grade 3 Alopecia.
8. Inability to start the next cycle of therapy due to treatment delay of more than 2 weeks because of lack of recovery.
9. Other MLN0264-related non-hematologic toxicities Grade 2 or greater requiring discontinuation of therapy.
Measured: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months
Maximum Tolerated Dose (MTD) of MLN0264
MTD of MLN0264 was determined. Decisions regarding dose escalation were made based on any DLT that occurred during the first cycle of treatment.
Measured: Every 3 weeks until MTD is established, approximately 9 months
Cmax: Maximum Observed Serum Concentration for MLN0264
Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.
Measured: Cycle 1: Day 1 pre-dose to Day 21 post-dose
Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.
Measured: Cycle 1: Day 1 pre-dose to Day 21 post-dose
AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MLN0246
Area under the drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.
Measured: Cycle 1: Day 1 pre-dose to 21 Days post-dose
AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MMAE
Area under the plasma drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.
Measured: Cycle 1: Day 1 pre-dose to 21 Days post-dose

Secondary outcomes (2)

Best Overall Response
The percentage of participants in each best overall response category, was determined using the Modified Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response: Disappearance of all target lesions and all non-target lesions and normalization of tumor marker level.
Partial Response: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD.
Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the start or the appearance of one or more new lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Measured: At the completion of every second cycle up to 12 cycles (approximately 9 months). Each cycle is a 21 days cycle
Number of Participants With Antitherapeutic Antibodies (ATA)
Blood was collected and sent to a laboratory to determine the immunogenicity, whether binding antibodies to MLN0264 were present (ATA development).
Measured: Day 1 of every 21 days cycle and at End of study (EOS) approximately 9 months

Timeline

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

Jun 2012Feb 2014

First posted16 Apr 2012 (estimated)
Study startJun 2012
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Gastrointestinal MalignanciesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01577758
Sponsor's protocol ID: C26001
Other IDs: 2011-002260-24, U1111-1163-9720
Status last verified: Sep 2016
First submitted: 2 Apr 2012
Last updated: 7 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Advanced Gastrointestinal Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C
ClinicalTrials.gov ID: NCT01577758
Acronym / sponsor ID: C26001
Conditions: Advanced Gastrointestinal Malignancies
Keywords: Phase 1,, Advanced gastrointestinal malignancies,, MLN0264,, Guanylyl Cyclase C(GCC),, Antibody Drug Conjugate(ADC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 16 Apr 2012 (estimated)
Results: Posted 25 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MLN0264	Experimental	Drug: MLN0264MLN0264 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MLN0264MLN0264 30-minute infusion on Day 1 of each treatment cycle	Drug	MLN0264

Primary outcome

Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months
DLT was defined as any of the following Adverse Events (AEs) that occur and are considered by the investigator to be related to therapy. 1. Grade 4 neutropenia (Absolute Neutrophil Count < 500 cells/mm^3). 2. Grade 3 or greater neutropenia with fever and/or infection. 3. Grade 4 thrombocytopenia (platelets < 25,000/mm^3). 4. Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time. 5. Grade 3 or greater nausea and/or emesis that occurs despite of prophylaxis. 6. Grade 3 or greater diarrhea that occurs despite supportive care. 7. Any other Grade 3 or greater non-hematological toxicity other than Grade 3 fatigue or Grade 3 Alopecia. 8. Inability to start the next cycle of therapy due to treatment delay of more than 2 weeks because of lack of recovery. 9. Other MLN0264-related non-hematologic toxicities Grade 2 or greater requiring discontinuation of therapy.
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Time frame: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Maximum Tolerated Dose (MTD) of MLN0264
Time frame: Every 3 weeks until MTD is established, approximately 9 months
MTD of MLN0264 was determined. Decisions regarding dose escalation were made based on any DLT that occurred during the first cycle of treatment.
Cmax: Maximum Observed Serum Concentration for MLN0264
Time frame: Cycle 1: Day 1 pre-dose to Day 21 post-dose
Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.
Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)
Time frame: Cycle 1: Day 1 pre-dose to Day 21 post-dose
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.
AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MLN0246
Time frame: Cycle 1: Day 1 pre-dose to 21 Days post-dose
Area under the drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.
AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MMAE
Time frame: Cycle 1: Day 1 pre-dose to 21 Days post-dose
Area under the plasma drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.

2 secondary outcomes

Best Overall Response
Time frame: At the completion of every second cycle up to 12 cycles (approximately 9 months). Each cycle is a 21 days cycle
Number of Participants With Antitherapeutic Antibodies (ATA)
Time frame: Day 1 of every 21 days cycle and at End of study (EOS) approximately 9 months

Results and safety

Results posted to the registry on 25 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MLN0264 0.3 mg/kg	2	0
MLN0264 0.6 mg/kg	2	0
MLN0264 1.2 mg/kg	2	0
MLN0264 1.5 mg/kg	2	0
MLN0264 1.8 mg/kg	6	0
MLN0264 2.1 mg/kg	4	0
MLN0264 2.4 mg/kg	1	0
MLN0264 1.8 mg/kg (mCRC Expansion)	0	0

Primary outcome: Number of Participants With Dose-Limiting Toxicities (DLTs)

Time frame: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months. Number. Unit: participants

Measure	MLN0264 0.3 mg/kg n = 2	MLN0264 0.6 mg/kg n = 2	MLN0264 1.2 mg/kg n = 2	MLN0264 1.5 mg/kg n = 2	MLN0264 1.8 mg/kg n = 6	MLN0264 2.1 mg/kg n = 4	MLN0264 2.4 mg/kg n = 1
Value	0	0	0	0	1	2	1

Population analysed: DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.

Primary outcome: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Time frame: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months. Number. Unit: participants

Measure	MLN0264 Dose Escalation Phase n = 19	MLN0264 1.8 mg/kg (mCRC Expansion) n = 25
Adverse Events	19	25
Serious Adverse Events	8	9

Population analysed: Safety Analysis Set included all participants who received at least one dose of study drug.

Primary outcome: Maximum Tolerated Dose (MTD) of MLN0264

Time frame: Every 3 weeks until MTD is established, approximately 9 months. Number. Unit: mg/kg

Measure	MLN0264 Dose Escalation Phase n = 19
Value	1.8

Primary outcome: Cmax: Maximum Observed Serum Concentration for MLN0264

Time frame: Cycle 1: Day 1 pre-dose to Day 21 post-dose. Geometric mean (Full Range). Unit: μg/mL

Measure	MLN0264 1.8 mg/kg n = 28
Value	48.63 (34.10 to 85.90)

Population analysed: Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time informed consent is signed through 30 days after the last dose of study drug (approximately 9 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MLN0264 0.3 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
MLN0264 0.6 mg/kg	2 of 2 (100%)	2 of 2 (100%)	Not reported
MLN0264 1.2 mg/kg	1 of 2 (50%)	2 of 2 (100%)	Not reported
MLN0264 1.5 mg/kg	0 of 2 (0%)	2 of 2 (100%)	Not reported
MLN0264 1.8 mg/kg	10 of 28 (35.7%)	28 of 28 (100%)	Not reported
MLN0264 2.1 mg/kg	2 of 4 (50%)	4 of 4 (100%)	Not reported
MLN0264 2.4 mg/kg	1 of 1 (100%)	1 of 1 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Millennium Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MLN0264 in people with Advanced Gastrointestinal Malignancies, run by Millennium Pharmaceuticals, Inc. at 1 site 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 7 inclusion and 9 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 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 25 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months). The study lists 7 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 NCT01577758.

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 7 Sep 2016.