Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00838539

Purpose

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.

Condition	Intervention	Phase
Neoplasms Malignant Carcinoma	Drug: Neratinib Drug: Temsirolimus	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Sirolimus Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	65
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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. In Amendment 2, an MTD expansion cohort was added to enroll approximately 12 patients with target mutations in NSCLC.	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

Arms

Assigned Interventions

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. In Amendment 2, an MTD expansion cohort was added to enroll approximately 12 patients with target mutations in NSCLC.

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

Eligibility

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

Criteria

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.
For MTD expansion cohort, a confirmed molecular profile of Her2 exon 20 insertion mutations in patients with NSCLC.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838539

Locations

United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02110
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
France
Pfizer Investigational Site
Villejuif, France, 94805

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00838539 History of Changes
Other Study ID Numbers:	3144A1-2205, B1891016
Study First Received:	February 5, 2009
Last Updated:	January 12, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Neratinib in combination with Temsirolimus
solid tumors
phase 1
dose finding study

Additional relevant MeSH terms:

Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 09, 2012