Dose Escalation Study With MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors (MK-2206-002)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Neoplasms; Cancer; Metastatic Solid Tumors; Locally Advanced Tumors

Treatments: Drug: MK-2206

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670488

2008_513 (Other Identifier)

2206-002

MK-2206-002 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to investigate the Dose Limiting Toxicities (DLTs), pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2206 administered orally to participants with advanced solid tumors. The preliminary efficacy of MK-2206 will also be investigated.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy
• Has normal organ function; is no greater than 2 on the ECOG Performance Scale
• Has a negative blood or urine pregnancy test within 72 hours of receiving the first dose of study drug if participant is female
• Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis

Exclusion criteria

• Participant has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment
• Is currently participating or has participated in a study with an investigational compound or device within 30 days
• Has a primary central nervous system tumor
• Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure
• Is a known diabetic who is taking insulin or oral antidiabetic therapy
• Is pregnant or breastfeeding or planning to become pregnant during the study
• Is HIV-positive
• Has known history of Hepatitis B or C or active Hepatitis A
• Is receiving treatment with oral corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

104 participants in 10 patient groups

MK-2206 30 mg QOD

Experimental group

Description:

Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206

MK-2206 60 mg QOD

Experimental group

Description:

Participants receive 60 mg oral MK-2206 QOD in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206

MK-2206 75 mg QOD

Experimental group

Description:

Participants receive 75 mg oral MK-2206 QOD in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206

MK-2206 90 mg QOD

Experimental group

Description:

Participants receive 90 mg oral MK-2206 QOD in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206

MK-2206 90 mg QW

Experimental group

Description:

Participants receive 90 mg oral MK-2206 every week (QW) in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206

MK-2206 135 mg QW

Experimental group

Description:

Participants receive 135 mg oral MK-2206 QW in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206

MK-2206 200 mg QW

Experimental group

Description:

Participants receive 200 mg oral MK-2206 QW in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206

MK-2206 300 mg QW

Experimental group

Description:

Participants receive 300 mg oral MK-2206 QW in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206

MK-2206 250 mg QW

Experimental group

Description:

Participants receive 250 mg oral MK-2206 QW in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206

MK-2206 150 mg QW

Experimental group

Description:

Participants receive 150 mg oral MK-2206 QW in repeating 4-week treatment cycles.

Treatment:

Drug: MK-2206