Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00954512
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
  • Epirubicin — DRUG
  • Trastuzumab — BIOLOGICAL
  • Everolimus — DRUG
  • Gemcitabine — DRUG
  • Robatumumab — BIOLOGICAL
    In Part 1, robatumumab was to be administered at 10 mg/kg, 15 mg/kg (for Regimens B and C), or 20 mg/kg together with the assigned standard treatment. For Part 2, robatumumab was to be administered at the dose selected during Part 1, based upon the maximum tolerated dose (MTD) or maximum administered dose (MAD), pharmacokinetic (PK) and pharmacodynamic (PD) data.
  • Cetuximab — BIOLOGICAL
  • Paclitaxel — DRUG
  • Cisplatin — DRUG
  • 5-FU — DRUG
  • Erlotinib — DRUG
  • Irinotecan — DRUG
  • Folinic Acid — DRUG

Study Details

This is a Phase 1B/2, non-randomized, dose-escalation, multicenter, open-label study designed to evaluate the safety and tolerability of robatumumab (SCH 717454, MK-7454) in combination with standard treatment in participants with advanced solid tumors to be conducted in conformance with Good Clinical Practices. Six different treatment regimens will be investigated in combination with robatumumab. The study will be divided into two parts. Part 1 will consist of initial safety evaluation and dose-finding of robatumumab in combination with each treatment regimen. Part 2 will consist of an expansion of each robatumumab regimen at a newly established dose level, to better define safety, tolerability, and initial efficacy in specific target populations.

Key Dates

Start date
Sep 25, 2009
Status verified
Jul 2018
Primary completion
Jun 7, 2011
Completion
Jun 7, 2011

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A: FOLFIRI (± Cetuximab) + Robatumumab
    Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m\^2+ folinic acid 400 mg/m\^2+ 5-fluorouracil \[5-FU\] 400 mg/m\^2 bolus followed by 2400 mg/m\^2 intravenous \[IV\] infusion over 46 hours) (± cetuximab initial dose of 400 mg/m\^2 IV followed by once-weekly doses of 250 mg/m\^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
  • Experimental: Regimen B: Carboplatin + Paclitaxel + Robatumumab
    Participants with non-small cell lung cancer receive carboplatin administered at an area under the curve (AUC) of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m\^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
  • Experimental: Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab
    Participants with gastric adenocarcinoma receive epirubicin 50 mg/m\^2 IV PLUS cisplatin 60 mg/m\^2 IV PLUS 5-FU 200 mg/m\^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
  • Experimental: Regimen D: Trastuzumab + Robatumumab
    Participants with human epidermal growth factor receptor 2 positive (Her2+) breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
  • Experimental: Regimen E: mTor Inhibitor (Everolimus) + Robatumumab
    Participants with renal cell cancer receive mammalian target of rapamycin (mTor) inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
  • Experimental: Regimen F: Gemcitabine (± Erlotinib) + Robatumumab
    Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m\^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)

Primary Outcome Measure

Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response [ Time Frame: Up to ~30 days after the final dose of robatumumab (Up to ~14 months) ]

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