A Study of MLN0264 in Patients With Pancreatic Cancer

NCT02202785 | Terminated Phase 2 Results

• 4 other identifiers: C260032014-000805-11U1111-1155-8964REec-2014-1177
• Study Type: interventional
• Target: 43
• Locations: 4 countries
• Sites: 16

Brief Summary

The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in patients with advanced or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the pancreas.

Conditions

Pancreatic Adenocarcinoma

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)

  ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.

  Day 21, every other cycle, starting with Cycle 2 until disease progression, death or study closure (Up to 16 months)

Secondary Outcomes (14)

• Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings

  Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 7.9 months)

• Number of Participants With Potentially Clinically Significant Vital Signs Findings

  Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 7.9 months)

• Progression Free Survival (PFS)

  Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 13.9 months)

• Duration of Response

  From first documented response until disease progression (Up to 16 months)

• Disease Control Rate

  Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 13.9 months)

Study Arms (1)

MLN0264 1.8 mg/kg

EXPERIMENTAL

MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.

Drug: MLN0264

Interventions

MLN0264 DRUG

MLN0264 IV infusion

MLN0264 1.8 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants 18 years of age or older when written informed consent is obtained.
• Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the pancreas with immunohistochemistry (IHC) evidence of guanylyl cyclase C (GCC) expression indicated by an H-score of 10 or greater.
• Treatment with 1 or more prior chemotherapies for advanced or metastatic adenocarcinoma of the pancreas.
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. All scans and x-rays used to document measurable disease must be done within 28 days before enrollment (ascites and bone lesions are not considered measureable disease).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days before enrollment.
• Female participants who:
• Are postmenopausal for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.)
• Male participants, even if surgically sterilized (ie, status postvasectomy), who:
• Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods for the female partner\] and withdrawal are not acceptable methods of contraception.)
• Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
• Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment:

You may not qualify if:

• Radiotherapy within 4 weeks before enrollment.
• Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent or chemotherapy.
• Female participants who are lactating and breastfeeding or have a positive pregnancy test during the Screening period.
• Uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months before enrollment, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication.
• Treatment with any medication that has a clinically relevant potential risk of prolonging the QT interval or inducing torsades de pointes that cannot be discontinued or switched to a different medication before starting study drug.
• Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc).
• Ongoing or clinically significant active infection as judged by the investigator.
• Signs of peripheral neuropathy (PN) ≥ NCI CTCAE Grade 2.
• Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment.
• Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug.
• Any preexisting medical condition of sufficient severity to prevent full compliance with the study.
• History of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri.
• Known diagnosis of human immunodeficiency virus (HIV) infection (testing is not mandatory).
• Symptomatic brain metastases.
• Ongoing anticoagulant therapy (eg, aspirin, coumadin, heparin).

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (16)

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

St. Petersburg, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Bruges, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Barcelona, Barcelona, Spain

Location

Unknown Facility

Madrid, Madrid, Spain

Location

Unknown Facility

Málaga, Malaga, Spain

Location

Unknown Facility

Seville, Sevilla, Spain

Location

Unknown Facility

London, Greater London, United Kingdom

Location

Unknown Facility

Manchester, Greater Manchester, United Kingdom

Location

Unknown Facility

Sutton, Surrey, United Kingdom

Location

Related Publications (1)

• Almhanna K, Wright D, Mercade TM, Van Laethem JL, Gracian AC, Guillen-Ponce C, Faris J, Lopez CM, Hubner RA, Bendell J, Bols A, Feliu J, Starling N, Enzinger P, Mahalingham D, Messersmith W, Yang H, Fasanmade A, Danaee H, Kalebic T. A phase II study of antibody-drug conjugate, TAK-264 (MLN0264) in previously treated patients with advanced or metastatic pancreatic adenocarcinoma expressing guanylyl cyclase C. Invest New Drugs. 2017 Oct;35(5):634-641. doi: 10.1007/s10637-017-0473-9. Epub 2017 May 19.

  PMID: 28527133 DERIVED

MeSH Terms

Interventions

indusatumab

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 29, 2014
• Study Start: July 2, 2014
• Primary Completion: January 15, 2016
• Study Completion: January 15, 2016
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-04

Locations

US (7); GB (3); ES (4); BE (2)