Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Puma Biotechnology, Inc.

ClinicalTrials.gov Identifier:

NCT00838539

First received: February 5, 2009

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 5, 2009

Last Updated Date

January 28, 2013

Start Date ^ICMJE

April 2009

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine the Maximum Tolerated Dose (MTD) toxicity contour of the combination of neratinib and temsirolimus. [ Time Frame: Approximately 12 months ] [ Designated as safety issue: Yes ]
Identify the recommended phase 2 dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Maximum Tolerated Dose (MTD) [ Time Frame: Approx. 12 months ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00838539 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess pharmacokinetic parameters of neratinib and temsirolimus in combination [ Time Frame: Approximately 24 months (post MTD confirmation) ] [ Designated as safety issue: Yes ]
Gather additional safety and tolerability information to inform the recommended phase 2 dose combinations [ Time Frame: Duration of trial ] [ Designated as safety issue: Yes ]
Explore preliminary evidence of antitumor activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Preliminary Efficacy, Pharmacokinetics and Additional Safety [ Time Frame: Approx. 12 months ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

Official Title ^ICMJE

A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

Brief Summary

The primary purpose of this study is to identify the maximum tolerated dose(s) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Neoplasms
Malignant Carcinoma

Intervention ^ICMJE

Drug: Neratinib
neratinib 40mg tablets will be taken orally in doses of either 120mg, 160mg, 200mg OR 240mg daily dose, for as long tolerated and the disease under study does not worsen.

Other Name: HKI-272
Drug: Temsirolimus
Temsirolimus will be administered intravenously once a week, at either 15mg, 25mg, 50, or 75mg, for as long as tolerated and the disease under study does not worsen.

Other Name: Torisel, temsr, CCI-779

Study Arm (s)

Experimental: 1

Neratinib + Temsirolimus phase 1 dose finding study. Incorporating an Up and Down study design which will evaluate up to 16 dose combinations of neratinib in combination with temsirolimus.

Interventions:

Drug: Neratinib
Drug: Temsirolimus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Pathologic diagnosis of advanced or metastatic solid tumor.
Measurable disease per Response Criteria in Solid Tumors (RECIST criteria).
Incurable cancer, with disease progression following at least 1 conventional or standard therapy for locally advanced or metastatic disease.
Negative pregnancy test for women of child bearing potential.

Exclusion Criteria:

Chronic treatment with corticosteroids.
Primary central nervous system (CNS) tumors and active metastases.
Presence of clinically significant or uncontrolled cardiac disease.
Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
Symptomatic or prior history of non-infectious interstitial pneumonitis.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France

Administrative Information

NCT Number ^ICMJE

NCT00838539

Other Study ID Numbers ^ICMJE

3144A1-2205, B1891016

Has Data Monitoring Committee

Responsible Party

Puma Biotechnology, Inc.

Study Sponsor ^ICMJE

Puma Biotechnology, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Puma

Biotechnology

Information Provided By

Puma Biotechnology, Inc.

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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