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Phase I Parallel Protocol of MK-8669 (Ridaforolimus) + MK-2206 and MK-8669 (Ridaforolimus) + MK-0752 Doublets (MK-MK) in Patients With Advanced Cancer

Phase 1
18 Years
Open (Enrolling)
Advanced Cancer

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Trial Information

Phase I Parallel Protocol of MK-8669 (Ridaforolimus) + MK-2206 and MK-8669 (Ridaforolimus) + MK-0752 Doublets (MK-MK) in Patients With Advanced Cancer

Inclusion Criteria:

Part A of the Study:

Participant must have a histologically-confirmed metastatic or locally advanced solid
tumor that has failed to respond to standard therapy, progressed despite standard therapy,
or for which standard therapy does not exist. Non Hodgkin Lymphoma (NHL) participants (in
Part A only), must have histologically confirmed relapsed/refractory NHL. There is no
limit on the number of prior treatment regimens.

Part B of the Study:

- Participant must have performance status of 0 or 1 on the Eastern Cooperative
Oncology Group (ECOG) Performance Scale.

- Participant must have adequate organ function.

- Participants must be willing to use effective methods of contraception.

- Participant is able to swallow capsules and has no surgical or anatomical condition
that will preclude the participant from swallowing and absorbing oral medications on
an ongoing basis.

- Participant has no history of a prior malignancy with the exception of cervical
intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated
localized prostate carcinoma with Prostate-Specific Antigen (PSA) <1.0; or who has
undergone potentially curative therapy with no evidence of that disease for five
years, or who is deemed at low risk for recurrence by his/her treating physician.

- Participant has at least one measurable recurrent or metastatic lesion (if a solitary
lesion, histological/cytological confirmation of its neoplastic nature is required)
with the exception of prostate cancer participants which do not require measurable
disease if participant has PSA level of >10 ng/mL.

- Participant must agree to provide archival or newly-obtained tumor tissue sample.

- Ridaforolimus + MK-2206 Treatment Arm:

- Participant must have a histologically-confirmed prostate cancer that is
refractory to hormone therapy and for which the participant received any
number of prior treatment regimens (no longer recruiting as of 30 November
2012), OR

- Participant must have a histologically-confirmed breast cancer for which
the participant received any number of prior treatment regimens. Archival
or fresh tissue must demonstrate a low RAS-gene signature and a high Ki67
index label if estrogen receptor (ER)+

- Ridaforolimus + MK-0752 Treatment Arm:

- Participant must have a histologically-confirmed recurrent (either primary
or secondary) glioblastoma multiforme with radiographic evidence of
progression/recurrence of disease, and up to 2 prior treatment regimens for
their recurrent disease, and no prior treatment with bevacizumab, OR

- Participants must have a histologically-confirmed relapsed or refractory
ovarian cancer for which the participant received no more than 2 prior
treatment regiments which was either relapsed or refractory to the first
line treatment.

Exclusion Criteria:

- Participant has had chemotherapy or radiotherapy within 4 weeks prior to study Day 1
(6 weeks for nitrosoureas, mitomycin C), biological therapy (excluding antibodies)
within 2 weeks prior to study Day 1, or who has not recovered (≤Grade 1 or baseline)
from adverse events due to agents administered more than 4 weeks earlier.
Luteinizing-hormone releasing hormone (LHRH) use by prostate cancer patients is
permitted; participants with prostate cancer previously treated with flutamide or
nilutamide require 4 week washout period and participants previously treated with
bicalutamide require 6 week washout period before study drug administration.

- Participant is currently participating or has participated in a study with an
investigational compound or device within 28 days, or 5X half-life of the
investigational compound (not including monoclonal antibodies), whichever is longer,
of Day 1 of this study.

- Participants with known symptomatic or progressing Central Nervous System (CNS)
metastases and/or carcinomatous meningitis are excluded. However, participants with
CNS metastases who are asymptomatic and have completed a course of therapy are
eligible for the study provided they are clinically stable for 1 month prior to entry
as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or
on a stable dose of steroids.

- Participant has known hypersensitivity to the components of study drug or its

- Participant has prior exposure to agents that have the same target as to the study

- Participant has significant or uncontrolled cardiovascular disease, including New
York Heart Association (NYHA) Class III-IV heart failure, unstable angina, or a
myocardial infarction within the last 6 months.

- Participant is a known diabetic participant who is poorly controlled at screening.

- Participant has known psychiatric or substance abuse disorders that would interfere
with compliance with study requirements.

- Participant is, at the time of signing informed consent, a regular user (including
"recreational use") of any illicit drugs or had a recent history (within the last
year) of drug or alcohol abuse.

- Participant is pregnant or breastfeeding, or expecting to conceive or father children
within the projected duration of the study.

- Participant is known to be Human Immunodeficiency Virus (HIV)-positive.

- Participant has active Hepatitis B or C.

- Participant has symptomatic ascites or pleural effusion. A participant who is
clinically stable following treatment for these conditions is eligible.

- Participant has a requirement for concurrent treatment with immunosuppressive agents
other than prescribed corticosteroids at stable doses for ≥ 2 weeks prior to first
planned dose of study drug.

- Participant has a requirement for concurrent treatment with medication(s) that
strongly or moderate induce or inhibit cytochrome P450 (CYP3A). Participants should
be off these medications ≥ 2 weeks prior to the first dose of study medication.

- For participants with glioblastoma, dexamethasone should be discontinued at
least 1 week prior to the first dose of study drugs.

For participants on the Ridaforolimus + MK-0752 treatment arm:

- Participant requires or anticipated to require concomitant therapy with enzyme-inducing
antiepileptic therapy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants receiving ridaforolimus + MK-2206 who experience dose-limiting toxicities (DLTs).

Outcome Time Frame:

Cycle 1 (28 days)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

March 2014

Related Keywords:

  • Advanced Cancer
  • Recurrent glioblastoma multiforme
  • Hormone resistant prostate cancer
  • Relapsed ovarian carcinoma
  • Refractory ovarian carcinoma
  • Refractory breast cancer
  • Relapsed breast cancer
  • Neoplasms



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