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

NCT ID: NCT00838539

Last Updated: 2018-09-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-12-31

Brief Summary

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The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) 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.

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Detailed Description

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Conditions

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Neoplasms Malignant Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neratinib and Temsirolimus (Dose level 1)

Neratinib 120 mg and Temsirolimus 15 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 2)

Neratinib 120 mg and Temsirolimus 25 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 3)

Neratinib 120 mg and Temsirolimus 50 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 4)

Neratinib 120 mg and Temsirolimus 75 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 5)

Neratinib 160 mg and Temsirolimus 15 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 6)

Neratinib 160 mg and Temsirolimus 25 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 7)

Neratinib 160 mg and Temsirolimus 50 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 8)

Neratinib 160 mg and Temsirolimus 75 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 9)

Neratinib 200 mg and Temsirolimus 15 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 10)

Neratinib 200 mg and Temsirolimus 25 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 11)

Neratinib 200 mg and Temsirolimus 50 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Neratinib and Temsirolimus (Dose level 12)

Neratinib 240 mg and Temsirolimus 15 mg: Neratinib 40 mg tablets administered orally daily for as long as tolerated and the disease under study does not worsen. Temsirolimus administered intravenously once weekly for as long as tolerated and the disease under study does not worsen

Group Type EXPERIMENTAL

Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Interventions

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Neratinib

Intervention Type DRUG

Temsirolimus

Intervention Type DRUG

Other Intervention Names

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HKI-272 Torisel, CCI-779

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Puma Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Puma

Role: STUDY_DIRECTOR

Biotechnology

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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United States France

References

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Gandhi L, Bahleda R, Tolaney SM, Kwak EL, Cleary JM, Pandya SS, Hollebecque A, Abbas R, Ananthakrishnan R, Berkenblit A, Krygowski M, Liang Y, Turnbull KW, Shapiro GI, Soria JC. Phase I study of neratinib in combination with temsirolimus in patients with human epidermal growth factor receptor 2-dependent and other solid tumors. J Clin Oncol. 2014 Jan 10;32(2):68-75. doi: 10.1200/JCO.2012.47.2787. Epub 2013 Dec 9.

Reference Type DERIVED
PMID: 24323026 (View on PubMed)

Other Identifiers

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3144A1-2205 / B1891016

Identifier Type: -

Identifier Source: org_study_id

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