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
|Condition or disease||Intervention/treatment||Phase|
|Advanced Stage Solid Tumors||Drug: M6620 Drug: Carboplatin Drug: Paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: M6620 Monotherapy or Combination Therapy||
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.
Subject will receive carboplatin intravenous infusion as a combination therapy on Day 1 of the study.
Subject will receive paclitaxel intravenous infusion as a combination therapy on Day 1, 8 and 15 of the study.
- 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 ]
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
|Royal Marsden NHS Foundation Trust|
|Sutton, United Kingdom|
|Study Director:||Medical Responsible||Merck KGaA, Darmstadt, Germany|