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Phase I Parallel Arm Study of MK-0646 (Dalotuzumab) + MK-2206, Dalotuzumab + MK-0752, and Dalotuzumab + MK-8669 (Ridaforolimus) Doublets (MK-MK Doublets) in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms Malignant

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Trial Information

Phase I Parallel Arm Study of MK-0646 (Dalotuzumab) + MK-2206, Dalotuzumab + MK-0752, and Dalotuzumab + MK-8669 (Ridaforolimus) Doublets (MK-MK Doublets) in Patients With Advanced Cancer


Inclusion Criteria:



- Participants must not have any medical conditions that may impact compliance with the
protocol, limit interpretation of study results, or pose an unacceptable medical
risk.

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

- Participant is able to swallow capsules and has no condition that will preclude
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 prostatic specific antigen (PSA) < 1.0; or has
undergone potentially curative therapy with no evidence of that disease for five
years, or is deemed at low risk for recurrence by his/her treating physician.

- Participant has at least one measurable metastatic or recurrent lesion according to
Response Criteria in Solid Tumors (RECIST)

Part A:

- 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, or participant is not a candidate for
standard therapy, or is unwilling to undergo standard therapy. There is no limit on the
number of prior treatment regimens.

Part B:

- A female participant assigned to the dalotuzumab + MK-2206 or dalotuzumab +
ridaforolimus treatment arms must have histologically-confirmed metastatic or
recurrent platinum-resistant ovarian cancer, fallopian tube cancer, or primary
peritoneal cancer that has failed to respond to standard therapy, progressed despite
standard therapy, or for which standard therapy does not exist, or participant is not
a candidate for standard therapy, or is unwilling to undergo standard therapy.
Participants may have received any number of prior treatment regimens.

- A participant assigned to the dalotuzumab + MK-0752 treatment arms must have
histologically-confirmed metastatic or recurrent wild-type KRAS colorectal cancer
that has failed to respond to standard therapy, progressed despite standard therapy,
or for which standard therapy does not exist, or participant is not a candidate for
standard therapy, or is unwilling to undergo standard therapy. Participants may have
received any number of prior treatment regimens.

- Participant agrees to provide archival tumor tissue sample or undergo biopsy for
analysis of gene expression levels.

Exclusion Criteria:

- Participant has had chemotherapy, radiotherapy, or biological therapy (including
monoclonal antibodies) within 4 weeks prior to study Day 1 (6 weeks for nitrosoureas
or mitomycin C) or who has not recovered from adverse events due to agents
administered more than 4 weeks earlier, or major surgery <4 weeks earlier.

- 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 (excluding monoclonal antibodies), whichever is longer, of
initial dosing on this study. Participants previously treated with a monoclonal
antibody will be eligible to participate after a 28 day washout period.

- Participants with known central nervous system (CNS) metastases and/or carcinomatous
meningitis are excluded.

- 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 known to have diabetes that is poorly controlled

- Participant is pregnant, breastfeeding, or expecting to conceive or father children
during the study

- Participant is known to be human immunodeficiency virus (HIV)-positive

- Participant has active Hepatitis B or C infection

- Participant has symptomatic ascites or pleural effusion

- Participant requires treatment with immunosuppressive agents other than prescribed
corticosteroids at stable doses for at least two weeks prior to the first dose of
study drug

- Participant requires treatment with medication(s) that strongly or moderately induce
or inhibit cytochrome P450

- Participant is using growth hormone or growth hormone inhibitors

- Participant requires treatment with therapeutic warfarin

Type of Study:

Interventional

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 with dose limiting toxicities (DLTs)

Outcome Time Frame:

Cycle 1 (28 days)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

0646-027

NCT ID:

NCT01243762

Start Date:

November 2010

Completion Date:

March 2013

Related Keywords:

  • Neoplasms Malignant
  • Colorectal cancer
  • Solid tumors
  • Ovarian cancer
  • Fallopian tube cancer
  • Primary peritoneal cancer
  • Neoplasms

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