Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
200 participants
INTERVENTIONAL
2012-12-10
2020-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
M6620
Gemcitabine
Cisplatin
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.
M6620
Cisplatin
Etoposide
Part B2
This part will be 3 + 3 dose escalation study of M6620 in combination with irinotecan in participants with advanced solid tumors.
M6620
Irinotecan
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.
M6620
Gemcitabine
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.
M6620
Cisplatin
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.
M6620
Cisplatin
Carboplatin
Interventions
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M6620
Gemcitabine
Cisplatin
Etoposide
Carboplatin
Irinotecan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Parts A and B/B2: Histologically or cytologically confirmed advanced solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or for whom regimens containing gemcitabine, cisplatin, etoposide, and/or irinotecan might be considered, and with measurable disease according to RECIST criteria
* Part C1:
For Pre-screening:
* Advanced (metastatic or locally-advanced unresectable and not eligible for definitive treatment, e.g., surgery/radiotherapy), histologically confirmed non-small cell lung cancer (NSCLC)
* Available historical tumor specimen at the time of pre-screening or willing to provide a tumor biopsy (core) if the biopsy may be considered as part of standard clinical practice for the participant
* Received or did not tolerate standard approved targeted therapy, if appropriate for tumor genotype
For Screening:
* Measurable disease according to RECIST criteria
-Part C2:
* Advanced (locally-advanced incurable or metastatic) histologically confirmed estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) negative breast cancer.
* Adequate available historical tumor specimen or willing to provide a tumor biopsy (core) if the biopsy may be considered as part of standard clinical practice for the participant
* Measurable disease according to RECIST criteria
-Part C3:
* Advanced (locally-advanced incurable or metastatic) histologically confirmed SCLC that is platinum-resistant, defined as disease progression during initial treatment with a platinum-based regimen or progression within 90 days of completion of platinum therapy. Participants with platinum-resistant disease may receive a second-line non-platinum-based chemotherapy and subsequently be enrolled to this study. Participants who received and are resistant to a second-line platinum-based chemotherapy may also be enrolled into the study.
* Adequate available historical tumor specimen or willing to provide a tumor biopsy (core) if the biopsy may be considered as part of standard clinical practice for the participant
* Measurable disease according to RECIST criteria
* WHO performance status of 0 or 1
* Life expectancy of \>=12 week
* Hematological and biochemical indices within protocol specified ranges at screening.
Exclusion Criteria
* Parts A, B and B2:
* Greater than 6 cycles of prior treatment with cisplatin and/or carboplatin.
1. Part A/B: History of prior dose reductions or dose interruptions while receiving cisplatin or carboplatin due to toxicity from the platinum or intolerance to either agent.
2. Part B2: Prior exposure to irinotecan is permitted except for participants with a known hypersensitivity reaction to irinotecan.
* Participants with a known history of Grade 4 thrombocytopenia or Grade 4 neutropenia while receiving prior therapy.
* Part C1:
* Any cytotoxic chemotherapy beyond 1 line of platinum-based chemotherapy. One additional line of non-platinum based therapy in the advanced setting
1. Pre-screening Only\*: Participants may currently be receiving platinum-based chemotherapy in the advanced setting, or have completed 1 line of platinum-based chemotherapy and are currently receiving a second-line non-platinum-based therapy or maintenance therapy
2. There is no restriction on prior immunotherapy or targeted therapy unless combined together with a cytotoxic agent
* Any prior gemcitabine for the treatment of NSCLC in any setting within 6 months
* Participants who are known to be TP53 wild-type, unless they are determined to have ATM loss of expression during screening or pre-screening or until all the planned participants with TP53 mutation are enrolled as determined by the medical monitor
* Participants with unknown TP53 mutational status will be enrolled until the group of approximately 10 participants without TP53 mutation or until all the planned participants with TP53 mutation are enrolled as determined by the medical monitor
* Part C2:
* Any prior platinum therapy in the adjuvant or neoadjuvant within 6 months of screening
* Relapse within 3 months of completion of prior adjuvant or neoadjuvant chemotherapy
* Any prior chemotherapy in the metastatic setting with the exception of either a taxane or an anthracycline in the first-line metastatic setting
(a) There is no restriction on prior immunotherapy or targeted therapy in the metastatic setting unless combined together with a cytotoxic agent
* Participants with known BRCA1/BRCA2 germline mutations, either determined and documented prior to Screening, or determined during Screening. Participants with unknown BRCA1/BRCA2 status may be enrolled at discretion of the sponsor
* Participants who are documented to be non-basaloid subtype using molecular profiling assay (e.g. PAM50 assay) prior to Screening
* Participants with unknown BRCA1/BRCA2 or basaloid subtype status will be enrolled until the number of enrolled participant is approximately 40. If approximately 40 participants have been enrolled and a minimum of 30 participants who are basaloid positive and BRCA1/BRCA2 germline wild-type have not been enrolled, the basaloid subtype and BRCA status assay will be required at Screening to exclude participants who are basaloid negative or have BRCA1/BRCA2 germline mutations.
* Part C3:
* Prior platinum-sensitive participants , unless they progress on or within 90 days of completion of platinum-based regimen
* There is no restriction on prior immunotherapy or targeted therapy in the metastatic setting unless combined together with a cytotoxic agent
* During prior carboplatin therapy, requirement for dose reduction below AUC 5 mg.min/mL or discontinuation of carboplatin for toxicity or lack of tolerability.
* Unresolved toxicity of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater from previous anti-cancer therapy or radiotherapy
* History of spinal cord compression or brain metastases, unless asymptomatic, treated, stable, and not requiring treatment with steroids for at least 4 weeks before first dose of study drug. Any history of leptomeningeal metastases.
* Female participants who are already pregnant or lactating, or plan to become pregnant within 6 months of the last dose of study drug are excluded. Female participants of childbearing potential must adhere to contraception guidelines
* Male participants with partners of child-bearing potential must agree to adhere to contraception guidelines. Men with pregnant or lactating partners or partners who plan to become pregnant during the study or within 6 months of the last dose of study drug are excluded
* Serious cardiac or other co-morbid disease, as specified in the protocol
* Prior bone marrow transplant or extensive radiotherapy to greater than 15% of bone marrow
* Part C:
* Current malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
* Major surgery =\<2 weeks before starting study drug, or incomplete recovery from a prior major surgical procedure.
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Research & Development Institute, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
Locations
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Mayo Clinic Arizona
Phoenix, Arizona, United States
Sharp Memorial Hospital
San Diego, California, United States
Stanford, California, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Emory University
Atlanta, Georgia, United States
Northwestern Center for Clinical Research
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Breslin Cancer Center
Lansing, Michigan, United States
University Of Minnesota Hospital
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Hackensack University Medical Center PARTNER
Hackensack, New Jersey, United States
Long Island Jewish Medical Center - Monter Cancer Center
Lake Success, New York, United States
University Hospitals Case Medical Center - Case Comprehensive Cancer Center at
Cleveland, Ohio, United States
OSU - James Comprehensive Cancer Center - Division of Hematology
Columbus, Ohio, United States
Greenville Health System
Greenville, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
US Oncology - Texas Oncology-Midtown - Austin Midtown
Austin, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics - Partner
Houston, Texas, United States
Texas Oncology San Antonio Medical Cente
San Antonio, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Oncology Associates - Hampton
Norfolk, Virginia, United States
Northwest Cancer Specialists , P.C.
Vancouver, Washington, United States
Freeman Hospital - PARENT
Newcastle upon Tyne, England, United Kingdom
Churchill Hospital - PARENT
Oxford, England, United Kingdom
Beatson West of Scotland Cancer Centre - Dept of Medical Oncology
Glasgow, Scotland, United Kingdom
Royal Marsden Hospital - Dept of Oncology
Sutton, Surrey, United Kingdom
Guy's Hospital - PARENT
London, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
The Christie - Dept of Oncology
Manchester, , United Kingdom
Countries
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References
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Middleton MR, Dean E, Evans TRJ, Shapiro GI, Pollard J, Hendriks BS, Falk M, Diaz-Padilla I, Plummer R. Phase 1 study of the ATR inhibitor berzosertib (formerly M6620, VX-970) combined with gemcitabine +/- cisplatin in patients with advanced solid tumours. Br J Cancer. 2021 Aug;125(4):510-519. doi: 10.1038/s41416-021-01405-x. Epub 2021 May 26.
Shapiro GI, Wesolowski R, Devoe C, Lord S, Pollard J, Hendriks BS, Falk M, Diaz-Padilla I, Plummer R, Yap TA. Phase 1 study of the ATR inhibitor berzosertib in combination with cisplatin in patients with advanced solid tumours. Br J Cancer. 2021 Aug;125(4):520-527. doi: 10.1038/s41416-021-01406-w. Epub 2021 May 26.
Terranova N, Jansen M, Falk M, Hendriks BS. Population pharmacokinetics of ATR inhibitor berzosertib in phase I studies for different cancer types. Cancer Chemother Pharmacol. 2021 Feb;87(2):185-196. doi: 10.1007/s00280-020-04184-z. Epub 2020 Nov 4.
Other Identifiers
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VX12-970-001
Identifier Type: OTHER
Identifier Source: secondary_id
2012-003126-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS201923_0001
Identifier Type: -
Identifier Source: org_study_id
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