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: April 15, 2014
Last verified: April 2014
  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 1

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:


Further study details as provided by Puma Biotechnology, Inc.:

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 ]

Enrollment: 63
Study Start Date: April 2009
Study Completion Date: December 2013
Primary Completion Date: June 2011 (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.
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Investigational Site
Boston, Massachusetts, United States, 02215
Investigational Site
Boston, Massachusetts, United States, 02114
Investigational Site
Boston, Massachusetts, United States, 02110
Investigational Site
Boston, Massachusetts, United States, 02115
France
Investigational Site
Villejuif, France, 94805
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
  More Information

No publications provided by Puma Biotechnology, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00838539     History of Changes
Other Study ID Numbers: 3144A1-2205, B1891016
Study First Received: February 5, 2009
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Puma Biotechnology, Inc.:
Neratinib in combination with Temsirolimus
solid tumors
phase 1
dose finding study

Additional relevant MeSH terms:
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014