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ATRi Transition Rollover Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309150
Recruitment Status : Active, not recruiting
First Posted : October 13, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief Summary:
The main purpose of the study is to monitor the safety of subject receiving long-term treatment of M6620 as monotherapy or in combination with carboplatin and paclitaxel.

Condition or disease Intervention/treatment Phase
Advanced Stage Solid Tumors Drug: M6620 Drug: Carboplatin Drug: Paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Rollover Study to Provide Continued Treatment With M6620
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : January 12, 2021
Estimated Study Completion Date : January 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: M6620 Monotherapy or Combination Therapy Drug: M6620
Subject will either receive M6620 intravenously as a monotherapy on Day 1, 8 and 15 OR as a combination therapy on Day 2 and 9 of the study.

Drug: Carboplatin
Subject will receive carboplatin intravenous infusion as a combination therapy on Day 1 of the study.

Drug: Paclitaxel
Subject will receive paclitaxel intravenous infusion as a combination therapy on Day 1, 8 and 15 of the study.




Primary Outcome Measures :
  1. Occurrence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (Version 4.03) [ Time Frame: Up to Day 43 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects ongoing treatment in Vertex study VX13-970-002.
  • Subject must be able to understand and provide written informed consent.
  • Subject must be willing and able to comply with the scheduled visits, treatment plan, lifestyle,laboratory tests, contraceptive guidelines, and other study procedures.

Exclusion Criteria:

  • Subjects experiencing disease progression or unacceptable toxicity at the time of transition into the this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309150


Locations
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United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT03309150    
Other Study ID Numbers: MS201923-0007
2017-002354-37 ( EudraCT Number )
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck KGaA, Darmstadt, Germany:
Ataxia telangiectasia mutated and Rad3-related protein inhibitor (ATRi)
M6620
Solid tumors
Additional relevant MeSH terms:
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Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action