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

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: NCT01110603
Recruitment Status : Terminated
First Posted : April 26, 2010
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Tesaro, Inc.

Tracking Information
First Submitted Date  ICMJE April 22, 2010
First Posted Date  ICMJE April 26, 2010
Last Update Posted Date May 5, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2011)
Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Each cycle (21 or 28 Days) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: 21 Days ]
  • Maximum tolerated dose (MTD) of MK4827 in combination with carboplatin and paclitaxel [ Time Frame: 21 Days ]
  • Recommended Phase 2 dose (RP2D) of MK4827 in combination with carboplatin and paclitaxel [ Time Frame: 21 Days ]
Change History Complete list of historical versions of study NCT01110603 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2011)
Number of participants with clinical and laboratory adverse events (AEs) [ Time Frame: Baseline to 30 days post last dose ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
Official Title  ICMJE A Phase Ib Dose Escalation Study of MK-4827 in Combination With Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients With Advanced Solid Tumors
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer: Solid Tumors
Intervention  ICMJE
  • Drug: MK-4827
    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.
  • Drug: carboplatin
    Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle
  • Drug: paclitaxel
    Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle
  • Drug: liposomal doxorubicin
    Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle
Study Arms  ICMJE
  • Experimental: MK-4827 + carboplatin
    Interventions:
    • Drug: MK-4827
    • Drug: carboplatin
  • Experimental: MK-4827 + carboplatin/paclitaxel
    Interventions:
    • Drug: MK-4827
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: MK-4827 + carboplatin/liposomal doxorubicin
    Interventions:
    • Drug: MK-4827
    • Drug: carboplatin
    • Drug: liposomal doxorubicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 2, 2011)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2010)
105
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01110603
Other Study ID Numbers  ICMJE 2010_528
MK-4827-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tesaro, Inc.
Study Sponsor  ICMJE Tesaro, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tesaro, Inc.
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP