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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor, Multiple Myeloma

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability as assessed by incidence of dose limiting toxicities (DLTs)

Outcome Time Frame:

throughout study

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

Spain: Ministry of Health

Study ID:

2007_660

NCT ID:

NCT00701103

Start Date:

January 2006

Completion Date:

December 2009

Related Keywords:

  • Solid Tumor
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasms

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