Infusion of MK0646 in Subjects With Advanced Solid Tumors - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00635778

Purpose

This study will look for the highest tolerated dose of MK0646 when given as a every other week infusion in patients with advanced solid tumors.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: Comparator: MK0646	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title:	An Open-Label, Dose Escalation Phase I Trial of MK0646 Given as a One to Two Hour Every Other Week Infusion in Patients With Relapsed or Refractory Locally Advanced or Metastatic Cancers

Further study details as provided by Merck:

Primary Outcome Measures:

Blood concentrations of study drug; dose limiting toxicity (DLT) [ Time Frame: After first dose; prior to next dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

radiologic evaluation of tumor; RECIST criteria; evaluation of serum tumor biomarkers [ Time Frame: Before every other week drug infusion ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	July 2006
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Part 1: Experimental Part 1 is for determination of leading dose. It consists of three patients (up to a maximum of six) per dose level will be treated at rising dose levels of MK0646 consisting of a loading dose (2.5, 5.0, 10.0, 15.0, 20.0, and 30.0 mg/kg) followed by a subsequent every other week maintenance dose (of at least 2.5 mg/kg) starting two weeks after the completion of the loading dose.	Drug: Comparator: MK0646 Over 6 week duration, patients will receive infusion every one to two hours, at an escalating dose levels. (2.5, 5. 10, 15, 20, 30 mpk)
Part 2: Experimental Part 2 is for determination of maintenance dose. It consists of at least three new patients (up to a maximum of six) per dose level will be treated at rising maintenance dose levels of MK0646. All patients will receive the previous determined loading infusion from Part I, followed by a subsequent every other week maintenance infusion (2.5, 5.0, 10.0, 15.0, 20.0 mg/kg) starting two weeks after the loading infusion.	Drug: Comparator: MK0646 Over 6 week duration, patients will receive infusion every one to two hours, at an escalating dose levels. (2.5, 5. 10, 15, 20, 30 mpk)
Part 3: Experimental Part 3 is refinement of safety and pharmacokinetics. At the recommended phase 2 loading and every other week maintenance dose and schedule determined from Parts I and II, and additional 14-17 patients (for 20 patients total) will be enrolled for further refinement of the pharmacokinetics and safety of MK0646 administered at this dose and schedule.	Drug: Comparator: MK0646 Over 6 week duration, patients will receive infusion every one to two hours, at an escalating dose levels. (2.5, 5. 10, 15, 20, 30 mpk)

Detailed Description:

Trial Duration of Treatment : Patients will receive study drug for about 12 weeks. Patients may be able to receive MK0646 for as long as 1 year if it seems to be stopping the growth of their cancer and not causing bad side effects. If the patient has a complete response to MK0646, you can have up to 8 additional weeks of treatment.

Eligibility

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

Criteria

Inclusion Criteria:

Males and females with advanced solid tumors who have failed to respond to standard therapy, ages 18 years and older, with adequate organ function

Exclusion Criteria:

Patient is using growth hormones or growth hormone inhibitors
Patient is known to be allergic to components of the drug or similar drugs (e.g. monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin G
Patient has had chemotherapy, radiotherapy, or biological therapy within 4 - 6 weeks of entering the study or has not recovered from previous therapy
Patient is taking part in or has taken part in a study of an investigational compound or device within 30 days of their first dose of study drug
Patient has an active Central Nervous System metastases and/or carcinomatous meningitis. However, a patient who has completed a course of therapy and is clinical stable may be able to participate
Patient is pregnant or breastfeeding
Patient is HIV positive
Patient has a history of Hepatitis B or C
Patient has symptomatic ascites or pleural effusion. However, if the patient has received treatment and is stable, they may be able to participate
Female patient plans to become pregnant or a male patient who plans to impregnate their partner during the time the study is on going

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635778

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_511, MK0646-002
Study First Received:	February 29, 2008
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00635778 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neoplasm Metastasis

ClinicalTrials.gov processed this record on May 07, 2009