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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer: Solid Tumors

Thank you

Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with dose limiting toxicities (DLTs)

Outcome Time Frame:

Each cycle (21 or 28 Days)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

2010_528

NCT ID:

NCT01110603

Start Date:

July 2010

Completion Date:

July 2011

Related Keywords:

  • Cancer: Solid Tumors
  • Cancer
  • Advanced Solid Tumors
  • Neoplasms

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