ATRi Transition Rollover Study
Sponsor
Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03309150
Collaborator
(none)
1
1
1
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Study Details
Study Description
Brief Summary
The main purpose of the study is to monitor the safety of participant receiving long-term treatment of M6620 as monotherapy or in combination with carboplatin and paclitaxel.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
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
:
Jan 10, 2018
Anticipated Primary Completion Date
:
Dec 31, 2022
Anticipated Study Completion Date
:
Dec 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: M6620 Monotherapy or Combination Therapy
|
Drug: M6620
Participant 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
Participant will receive carboplatin intravenous infusion as a combination therapy on Day 1 of the study.
Drug: Paclitaxel
Participant will receive paclitaxel intravenous infusion as a combination therapy on Day 1, 8 and 15 of the study.
|
Outcome Measures
Primary Outcome Measures
- 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) [Up to Day 43]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants ongoing treatment in Vertex study VX13-970-002.
-
Participant must be able to understand and provide written informed consent.
-
Participant must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
Exclusion Criteria:
- Participants experiencing disease progression or unacceptable toxicity at the time of transition into the this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Marsden NHS Foundation Trust | Sutton | United Kingdom |
Sponsors and Collaborators
- Merck KGaA, Darmstadt, Germany
Investigators
- Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:
NCT03309150
Other Study ID Numbers:
- MS201923-0007
- 2017-002354-37
First Posted:
Oct 13, 2017
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
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
Additional relevant MeSH terms: