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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00701103
First received: June 17, 2008
Last updated: August 27, 2015
Last verified: August 2015
  Purpose
This study will look for the highest tolerated dose of MK-0646 given as weekly, every other week. or a every three week infusion.

Condition Intervention Phase
Solid Tumor
Multiple Myeloma
Drug: Comparator: MK-0646
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 MK-0646 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:
  • Percentage of participants who experience one or more dose limiting toxicities (DLTs) [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: Yes ]
  • Mean terminal half-life (t1/2) of MK-0646 [ Time Frame: Predose, 0.5 hours after start of infusion, right before end of infusion, and 5, 10, 24, 30, 48, and 96 hours following start of infusion ] [ Designated as safety issue: No ]
  • Area under the time-concentration curve from 0 to infinity hours (AUC0-∞) of MK-0646 [ Time Frame: Predose, 0.5 hours after start of infusion, right before end of infusion, and 5, 10, 24, 30, 48, and 96 hours following start of infusion ] [ Designated as safety issue: No ]
  • Mean serum clearance of MK-0646 [ Time Frame: Predose, 0.5 hours after start of infusion, right before end of infusion, and 5, 10, 24, 30, 48, and 96 hours following start of infusion ] [ Designated as safety issue: No ]
  • Mean trough serum concentration of MK-0646 [ Time Frame: Predose immediately prior to infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin-like growth factor receptor type 1 (IGF-1R) protein expression level [ Time Frame: Predose, predose at Weeks 2 and 5, predose every 4 subsequent weeks, and end of treatment ] [ 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 MK-0646 Weekly Infusion
Drug: Comparator: MK-0646
MK-0646 by intravenous infusion
Experimental: Dose Level 2
2.5 mg/kg MK-0646 Weekly Infusion
Drug: Comparator: MK-0646
MK-0646 by intravenous infusion
Experimental: Dose Level 3
5 mg/kg MK-0646 Weekly Infusion
Drug: Comparator: MK-0646
MK-0646 by intravenous infusion
Experimental: Dose Level 4
10 mg/kg MK-0646 Weekly Infusion
Drug: Comparator: MK-0646
MK-0646 by intravenous infusion
Experimental: Dose Level 5
15 mg/kg MK-0646 Weekly Infusion
Drug: Comparator: MK-0646
MK-0646 by intravenous infusion
Experimental: Dose Level 6
20 mg/kg MK-0646 Weekly Infusion
Drug: Comparator: MK-0646
MK-0646 by intravenous infusion
Experimental: Dose Level 7
15 mg/kg MK-0646 Loading dose followed by a 7.5 mg/kg Every Other Week Maintenance Infusion
Drug: Comparator: MK-0646
MK-0646 by intravenous infusion
Experimental: Dose Level 8
20 mg/kg MK-0646 Loading dose followed by a 20 mg/kg Every Other Week Maintenance Infusion
Drug: Comparator: MK-0646
MK-0646 by intravenous infusion
Experimental: Dose Level 9
20 mg/kg MK-0646 Loading dose followed by a 20 mg/kg Every Three Weeks Maintenance Infusion
Drug: Comparator: MK-0646
MK-0646 by intravenous infusion
Experimental: Dose Level 10
30 mg/kg MK-0646 Loading dose followed by a 30 mg/kg Every Three Weeks Maintenance Infusion
Drug: Comparator: MK-0646
MK-0646 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   (Adult, Senior)
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 congestive heart failure, 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 human immunodeficiency virus (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 Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00701103     History of Changes
Obsolete Identifiers: NCT00282737
Other Study ID Numbers: 0646-001  2007_660 
Study First Received: June 17, 2008
Last Updated: August 27, 2015
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 22, 2016