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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01110603
First received: April 22, 2010
Last updated: March 16, 2012
Last verified: March 2012

April 22, 2010
March 16, 2012
July 2010
July 2011   (final data collection date for primary outcome measure)
Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Each cycle (21 or 28 Days) ] [ Designated as safety issue: Yes ]
  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose (MTD) of MK4827 in combination with carboplatin and paclitaxel [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
  • Recommended Phase 2 dose (RP2D) of MK4827 in combination with carboplatin and paclitaxel [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01110603 on ClinicalTrials.gov Archive Site
Number of participants with clinical and laboratory adverse events (AEs) [ Time Frame: Baseline to 30 days post last dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
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

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.

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer: Solid Tumors
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01110603
2010_528, MK-4827-008
No
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2012

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