M6620 First in Human Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT02157792
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M6620 — DRUG
  • Gemcitabine — DRUG
  • Cisplatin — DRUG
  • Etoposide — DRUG
  • Carboplatin — DRUG
  • Irinotecan — DRUG

Study Details

An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics (PK) of M6620 in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors

Key Dates

Start date
Dec 10, 2012
Status verified
Mar 2020
Primary completion
Mar 11, 2020
Completion
Mar 11, 2020

Study Design

Enrollment
200 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    This part will be 3 + 3 dose escalation study of M6620 in combination with gemcitabine as well as gemcitabine and cisplatin in participants with advanced solid tumors.
  • Experimental: Part B
    This part will be 3 + 3 dose escalation study of M6620 in combination with cisplatin or cisplatin and etoposide in participants with advanced solid tumors.
  • Experimental: Part B2
    This part will be 3 + 3 dose escalation study of M6620 in combination with irinotecan in participants with advanced solid tumors.
  • Experimental: Part C1
    This will be the expansion part of the study in which participants with advanced non-small cell lung cancer (NSCLC) will be administered M6620 in combination with gemcitabine.
  • Experimental: Part C2
    This will be the expansion part of the study in which participants with advanced triple negative breast cancer (TNBC) will be administered M6620 in combination with cisplatin.
  • Experimental: Part C3
    This will be the expansion part of the study in which participants with platinum-resistant advanced small cell lung cancer (SCLC) will be administered M6620 in combination with cisplatin or carboplatin.

Primary Outcome Measure

Parts A, B, B2, C1, C2, C3: Safety parameters, including adverse event (AEs), clinical laboratory values (serum chemistry, hematology, and urinalysis), vital signs, and electrocardiogram (ECG) assessments [ Time Frame: Screening through Safety Follow-up (approximately 22 weeks) ]

Locations (24)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
Sharp Memorial HospitalSan DiegoCalifornia92123-
-StanfordCalifornia--
Rocky Mountain Cancer Centers, LLPDenverColorado80218-
Emory UniversityAtlantaGeorgia30322-
Northwestern Center for Clinical ResearchChicagoIllinois60611-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Breslin Cancer CenterLansingMichigan48910-
University Of Minnesota HospitalMinneapolisMinnesota55455-
Mayo Clinic - RochesterRochesterMinnesota55905-
Washington University in St. LouisSt LouisMissouri63110-
Hackensack University Medical Center PARTNERHackensackNew Jersey07601-
Long Island Jewish Medical Center - Monter Cancer CenterLake SuccessNew York11042-
University Hospitals Case Medical Center - Case Comprehensive Cancer Center atClevelandOhio44106-
OSU - James Comprehensive Cancer Center - Division of HematologyColumbusOhio43210-
Greenville Health SystemGreenvilleSouth Carolina29605-
Vanderbilt University Medical CenterNashvilleTennessee37232-
US Oncology - Texas Oncology-Midtown - Austin MidtownAustinTexas78705-
Texas Oncology, P.A.DallasTexas75231-
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics - PartnerHoustonTexas77030-
Texas Oncology San Antonio Medical CenteSan AntonioTexas78240-
Virginia Cancer Specialists, PCFairfaxVirginia22031-
Virginia Oncology Associates - HamptonNorfolkVirginia23502-
Northwest Cancer Specialists , P.C.VancouverWashington98684-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Arizona· Phoenix, AZSharp Memorial Hospital· San Diego, CARocky Mountain Cancer Centers, LLP· Denver, COEmory University· Atlanta, GANorthwestern Center for Clinical Research· Chicago, ILDana Farber Cancer Institute· Boston, MA

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