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Phase I Dose Escalation Trial of MK0646 in Advanced Solid Tumors and Multiple Myeloma (0646-001)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00701103
First received: June 17, 2008
Last updated: September 10, 2010
Last verified: September 2010
  Purpose

This study will look for the highest tolerated dose of MK0646 given as weekly, every other week. or a every three week infusion.


Condition Intervention Phase
Solid Tumor
Multiple Myeloma
Drug: Comparator: MK0646
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Dose Escalation Phase I Trial of MK0646 Given as a Weekly, Every Other Week, or Every Three Week Infusion in Patients With Advanced Solid Tumors and Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Safety and tolerability as assessed by incidence of dose limiting toxicities (DLTs) [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of MK0646 administered as an IV infusion [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pharmacokinetics/pharmacodynamics measures [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Level 1
1.25 mg/kg MK0646 Weekly Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion
Experimental: Dose Level 2
2.5 mg/kg MK0646 Weekly Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion
Experimental: Dose Level 3
5 mg/kg MK0646 Weekly Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion
Experimental: Dose Level 4
10 mg/kg MK0646 Weekly Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion
Experimental: Dose Level 5
15 mg/kg MK0646 Weekly Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion
Experimental: Dose Level 6
20 mg/kg MK0646 Weekly Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion
Experimental: Dose Level 7
15 mg/kg MK0646 Loading dose followed by a 7.5 mg/kg Every Other Week Maintenance Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion
Experimental: Dose Level 8
20 mg/kg MK0646 Loading dose followed by a 20 mg/kg Every Other Week Maintenance Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion
Experimental: Dose Level 9
20 mg/kg MK0646 Loading dose followed by a 20 mg/kg Every Three Week Maintenance Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion
Experimental: Dose Level 10
30 mg/kg MK0646 Loading dose followed by a 30 mg/kg Every Three Week Maintenance Infusion
Drug: Comparator: MK0646
MK0646 by intravenous infusion

Detailed Description:

Trial Duration of Treatment: Subjects can be treated for up to one year if their disease has not progressed and they are not having unmanageable side effects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has metastatic or locally advanced solid tumor or multiple myeloma
  • Tumor specimen has IGF-1R expression
  • Patient agrees to use birth control throughout study

Exclusion Criteria:

  • Patient must not be recovering from antineoplastic therapy in the last 4 weeks
  • Patient has participated in a clinical trial in the last 4 weeks
  • Patient has a history of heart problems such as CHF, angina, heart attack or stroke in the last 3 months
  • Patient is taking growth hormone or growth hormone inhibitors
  • If female, patient is pregnant or breastfeeding
  • Patient is HIV positive
  • Patient has a history of hepatitis B or C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701103

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00701103     History of Changes
Obsolete Identifiers: NCT00282737
Other Study ID Numbers: 2007_660, MK0646-001
Study First Received: June 17, 2008
Last Updated: September 10, 2010
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014