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
  Purpose

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.


Condition Intervention Phase
Cancer: Solid Tumors
Drug: MK-4827
Drug: carboplatin
Drug: paclitaxel
Drug: liposomal doxorubicin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Each cycle (21 or 28 Days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with clinical and laboratory adverse events (AEs) [ Time Frame: Baseline to 30 days post last dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-4827 + carboplatin 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
Experimental: MK-4827 + carboplatin/paclitaxel 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
Experimental: MK-4827 + carboplatin/liposomal doxorubicin 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: liposomal doxorubicin
Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01110603     History of Changes
Other Study ID Numbers: 2010_528, MK-4827-008
Study First Received: April 22, 2010
Last Updated: March 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Cancer
Advanced Solid Tumors

Additional relevant MeSH terms:
Neoplasms
Doxorubicin
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 20, 2014