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

Cancer: Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01110603
• Other study ID #: 2010_528
• Secondary ID: MK-4827-008
• Status: Terminated
• Phase: Phase 1
• First received: April 22, 2010
• Last updated: May 4, 2016
• Start date: July 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2012
• Source: Tesaro, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cancer: Solid Tumors

Intervention

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.
• carboplatin
Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle
• paclitaxel
Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle
• liposomal doxorubicin
Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tesaro, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dose limiting toxicities (DLTs)		Each cycle (21 or 28 Days)	Yes
Secondary	Number of participants with clinical and laboratory adverse events (AEs)		Baseline to 30 days post last dose	No