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MK-1775 and carboplatin

Phase 2

Epithelial Ovarian Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Sep 7, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

MK-1775 and carboplatin · 1 trial · 1 indication

Phase 2 1
NCT01164995Study With Wee-1 Inhibitor AZD1775 (MK-1775) and Carboplatin to Treat p53 Mutated Refractory and Resistant Ovarian CancerEpithelial Ovarian Cancer
COMPLETED24 Analytics
PHASE2COMPLETED
Study With Wee-1 Inhibitor AZD1775 (MK-1775) and Carboplatin to Treat p53 Mutated Refractory and Resistant Ovarian Cancer
Epithelial Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number and percentage of Participants with Adverse Events
During treatment with carboplatin and MK-1775 AEs will be recorded up to 30 days after treatment (or until death whatever comes first). Treatment will occur until progressive disease

Descriptive tables that summarize the number and percentage of patients that experience adverse events as categorized in the NCI CTCAE version 4.0 will be generated for the overall population. Laboratory assessments: screening/day 1, 8, 15 of each cycle, and regular physical examination at the start of each cycle or on indication will be performed and followed until 30 days after the end of study (defined as disease progression or unacceptable toxicity (AEs) or patient withdrawal or patient death) or in case of AEs or Stable disease until time of progression.

Radiological antitumor activity
As long as the patient is treated with carboplatin and MK-1775 radiological assessments will be performed every 2 cycles (42 days) until progressive disease occurs, and evaluated in comparison to the baseline scan

Radiological assessment (CT scan or MRI) per RECIST 1.1

Secondary Endpoints

Pharmacokinetics assessments (not in additional safety and efficacy cohort)
Cycle 1: day 1, 2, 3
Pharmacodynamic assessments (not in additional safety and efficacy cohort)
Cycle 1: Day 1 (pre-dose) and day 3 and Cycle 2: day 1
In the additional safety and preliminary anti-tumor activity cohort
From day of first treatment cycle until end of study (progression or death whatever comes first), assessed up to 24 months (estimated)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-1775 and carboplatinEXPERIMENTALMK-1775: oral capsules. Carboplatin: intravenous infusion in 30 minutes

Interventions

NameTypeDescription
MK-1775 and carboplatinDRUGCarboplatin will be administered in a dose resulting in AUC5 (i.v. 30 min) at day 1 of each cycle. Concomittantly with the start of the carboplatin infusion 225 mg of MK-1775 will be administered as an oral capsule, followed by 4 additional doses at 12 hour increments ( = 5 BID doses of MK-1775 in 2.5 days in total). One cycle will last 21 days.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histological or cytological proof of epithelial ovarian cancer, and proven p53 mutated pathway by PCR/Sequencing. IHC will also be performed. In the additional safety and efficacy cohort also inclusion of NSCLC, SCLC, cervical and endometrial cancer (only ovarian cancer cohort...

Countries:Netherlands
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Frequently asked questions about MK-1775 and carboplatin

What is MK-1775 and carboplatin used for?

MK-1775 and carboplatin is an investigational combination being studied for the treatment of epithelial ovarian cancer. It is specifically being evaluated in patients with p53 mutated refractory and resistant ovarian cancer. The combination is in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does MK-1775 and carboplatin target?

MK-1775 is a Wee-1 inhibitor, which targets the Wee-1 kinase, a protein involved in cell cycle regulation. The combination with carboplatin is being studied in patients with p53 mutated tumors. The study is biomarker-selected, meaning patients are chosen based on the presence of p53 mutations.

Who makes MK-1775 and carboplatin?

MK-1775 and carboplatin is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The combination is currently in Phase 2 clinical development for epithelial ovarian cancer.

What phase is MK-1775 and carboplatin in?

MK-1775 and carboplatin is in Phase 2 clinical development. It is an investigational combination and has not received FDA approval. The Phase 2 study has been completed, and the drug remains under investigation for the treatment of epithelial ovarian cancer.

What clinical trials is MK-1775 and carboplatin in?

MK-1775 and carboplatin has one completed clinical trial, identified as NCT01164995. This Phase 2 study, titled 'Study With Wee-1 Inhibitor AZD1775 (MK-1775) and Carboplatin to Treat p53 Mutated Refractory and Resistant Ovarian Cancer,' enrolled 24 female participants in the Netherlands.

Is MK-1775 the same as AZD1775?

Yes, MK-1775 is also known as AZD1775. The clinical trial NCT01164995 refers to the drug as both MK-1775 and AZD1775. This is the same Wee-1 inhibitor being studied in combination with carboplatin for epithelial ovarian cancer.