A Study of MK-4827 in Combination With Standard Chemother... | NCT01110603

Studies
A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)

NCT01110603

Sponsor

Tesaro, Inc.

Status

Terminated

Last Update Posted

May 5, 2016Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Cancer: Solid Tumors

Interventions

MK-4827
carboplatin
paclitaxel
liposomal doxorubicin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MK-4827-008

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Apr 22, 2010

First Submission Date that Met QC Criteria

Apr 23, 2010

First Posted Date

Apr 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2016

Last Update Posted Date

May 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.

Detailed Description

The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
MK-4827 + carboplatin	Experimental	Drug: MK-4827 Drug: carboplatin
MK-4827 + carboplatin/paclitaxel	Experimental	Drug: MK-4827 Drug: carboplatin Drug: paclitaxel
MK-4827 + carboplatin/liposomal doxorubicin	Experimental	Drug: MK-4827 Drug: carboplatin Drug: liposomal doxorubicin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK-4827	Drug	Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose.	MK-4827 + carboplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with dose limiting toxicities (DLTs)		Each cycle (21 or 28 Days)

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with clinical and laboratory adverse events (AEs)		Baseline to 30 days post last dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.
Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

Exclusion Criteria:

Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.
Participant has had more than two prior lines of chemotherapy.
Participant has known central nervous system metastases or a primary central nervous system tumor.
Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.
Participant is known to be human immunodeficiency virus (HIV) positive.
Participant has a history of Hepatitis B or C.
Participant has a symptomatic pleural effusion.
Participant with a left ventricular ejection fraction (LVEF) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the MK4827 + carboplatin/liposomal doxorubicin study arm.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
C545685	niraparib
D016190	Carboplatin
D017239	Paclitaxel
C506643	liposomal doxorubicin

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes

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Browse Branches

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