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History of Changes for Study: NCT02785068
Evaluation of MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer
Latest version (submitted January 10, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 24, 2016 None (earliest Version on record)
2 May 26, 2016 Outcome Measures and Study Status
3 August 2, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 November 11, 2016 Contacts/Locations and Study Status
5 November 29, 2016 Contacts/Locations and Study Status
6 December 1, 2016 Contacts/Locations and Study Status
7 January 10, 2017 Recruitment Status, Study Status, Study Design and Contacts/Locations
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Study NCT02785068
Submitted Date:  May 24, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: MM-151-06-12-04
Brief Title: Evaluation of MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer
Official Title: A Phase 1 Study Combining MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2016
Overall Status: Not yet recruiting
Study Start: May 2016
Primary Completion: May 2018 [Anticipated]
Study Completion: October 2018 [Anticipated]
First Submitted: May 11, 2016
First Submitted that
Met QC Criteria:
May 24, 2016
First Posted: May 27, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 24, 2016
Last Update Posted: May 27, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Merrimack Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: A phase 1b/2a study evaluating the combination of MM-151 + nal-IRI + 5-FU + Leucovorin in RAS/RAF wild-type Metastatic Colorectal Cancer.
Detailed Description:

Part 1: Patients will be enrolled to determine the maximum tolerated dose, safety and tolerability of MM-151 + nal-IRI + 5-FU + LV in patients with mCRC that are RAS/RAF wild-type.

Part 2: Patients will be enrolled at the maximum tolerated dose of MM-151 in combination with nal-IRI + 5-FU + LV to characterize initial efficacy in conjunction with levels of irinotecan and SN-38 measured in tissue.

Open or close this module Conditions
Conditions: Colorectal Cancer
Keywords: Phase I
Cancer
EGFR
Metastatic Colorectal Cancer
Oncology
RAS/RAF Wild-Type
Nal-IRI
EGFR Inhibitor
Oligoclonal Antibody
Nanoliposome
Nanoliposomal Irinotecan
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 28 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Phase 1b/2a

Phase 1b: Safety Evaluation - MM-151 (weekly dosing) in combination with fixed doses of nal-IRI 70mg/m2 + Leucovorin 400 mg/m2 + 5-FU 2400mg/m2 every two weeks.

Phase 2a: Expansion - MM-151 (Maximum Tolerated Dose or Recommended Phase 2 Dose) in combination with fixed doses of nal-IRI 70mg/m2 + Leucovorin 400 mg/m2 + 5-FU 2400 mg/m2.

Drug: MM-151
Oligoclonal antibody
Drug: nal-IRI
Nanoliposomal irinotecan
Other Names:
  • MM-398
  • Onivyde
Drug: Leucovorin
folinic acid
Other Names:
  • folinic acid
Drug: 5-FU
Chemotherapy
Other Names:
  • fluorouracil
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To find the phase II dose of MM-151 based on safety and tolerability of MM-151 + nal-IRI + 5-FU + Leucovorin that will be assessed through evaluation of dose limiting toxicity reporting.
[ Time Frame: The DLT timeframe is from date of first dose up until 42 days after that date ]

2. To correlate disease response according to RECIST with levels of irinotecan and SN-38 in tumor tissue
[ Time Frame: 2 years ]

Secondary Outcome Measures:
1. The adverse event profile of MM-151 + nal-IRI + 5-FU + leucovorin
[ Time Frame: 2 years ]

2. The PK parameters of MM-151 and nal-IRI will be described per Cmax
[ Time Frame: 2 years ]

3. Presence of immunogenicity will be assessed
[ Time Frame: 2 years ]

4. Objective response based on RECIST
[ Time Frame: 2 years ]

5. Measure pre-treatment and on-treatment levels of EGFR ligands
[ Time Frame: 2 years ]

6. The PK parameters of MM-151 and nal-IRI will be described per AUC
[ Time Frame: 2 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patients must be greater than 18 years of age
  • Patients must be able to provide informed consent
  • Patients must have KRAS/NRAS/BRAF wild-type colorectal cancer
  • Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 120 days following the last dose of any study therapy). This applies to women of childbearing potential as well as fertile men and their partners

Exclusion Criteria:

  • Patients who have had previous pelvic radiation treatment
  • Patients who are pregnant or lactating
  • Patients who have untreated (primary) or uncontrolled Central Nervous System (CNS) (primary or metastatic) malignancies; patients with CNS metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial.
  • History of any second malignancy in the last 3 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible.
  • Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days and bevacizumab within 28 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment
Open or close this module Contacts/Locations
Central Contact Person: Andrea Valencia
Telephone: 7747761488
Email: avalencia@merrimack.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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