Neoplasms
Conditions
Brief summary
This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.
Detailed description
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009
Interventions
DRUGComparator: ridaforolimus + dalotuzumab
Starting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s).
Sponsors
Ariad Pharmaceuticals
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist * In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but no more than three prior systemic therapy treatment regimens * You must be over the age of 18 years old * You must have a ECOG status performance of 0 or 1 * You must have good organ function * You must be willing to have skin and/or tumor biopsies
Exclusion criteria
* You have had cancer treatment within 4 weeks prior to entering the study or you still have bad side effects from previous therapies * You have an active infection that requires treatment * You are HIV positive or have a history of Hepatitis B or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the toxicity profile, maximum tolerated dose and recommended phase II dose. | MTD from Day 1 to Day 28 in Cycle 1 for disease progression |
Secondary
| Measure | Time frame |
|---|---|
| To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab | At prescribed timepoints as defined in the protocol |
Outcome results
None listed