Neoplasms Malignant Clinical Trial
Official title:
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
This is an open-label, two-part study to evaluate the safety and tolerability of combination
treatment with dalotuzumab + MK-2206, dalotuzumab + MK-0752, or dalotuzumab + ridaforolimus
(MK-8669). Part 1 of the study will determine the dose-limiting toxicities (DLTs) observed
after administration of each of the combinations at various doses and define the maximum
tolerated dose (MTD) of each combination. Part 2 of the study will assess preliminary
anti-tumor activity of these combinations (at MTD) in two groups of participants with
selected tumor biomarkers: one group with metastatic or recurrent platinum-resistant ovarian
cancer, fallopian tube cancer, or primary peritoneal cancer and one group with metastatic or
recurrent colorectal cancer. The dalotuzumab + ridaforolimus and dalotuzumab + MK-2206 arms
will be enriched with female platinum-resistant ovarian cancer, fallopian tube cancer, or
primary peritoneal cancer participants. The dalotuzumab + MK-0752 arm will be enriched with
metastatic or recurrent wild-type kirsten rat sarcoma (KRAS) colorectal cancer participants.
The primary hypothesis is that the DLTs observed in adult patients with locally advanced or
metastatic solid tumors after administration of each of the MK-MK doublets will be
dose-dependent to allow for definition of a MTD within each MK-MK doublet.
n/a
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