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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01164995Study With Wee-1 Inhibitor AZD1775 (MK-1775) and Carboplatin to Treat p53 Mutated Refractory and Resistant Ovarian CancerPHASE2 COMPLETED 24 — — Jul 1, 2010Apr 1, 2023Sep 7, 20231 Netherlands
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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 — 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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