NCT01829217

Brief Summary

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA has not yet approved sunitinib for your type of cancer. Sunitinib has been approved by the FDA for treatment of gastrointestinal stromal tumors, advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors. While most chemotherapies work by interfering with cancer cell replication, sunitinib works by blocking certain protein signals within the cell. Because sunitinib works differently from standard intravenous chemotherapies, we call it a "targeted therapy." This drug has also been used in other research studies and information from those other research studies suggests that this agent may help to slow the growth of some NSCLC tumors. In this research study, we are looking to see if sunitinib may stop certain NSCLC tumors from growing. The study focuses on a type of NSCLC, adenocarcinoma, which has previously been found to be more sensitive to other kinds of oral targeted therapies. This study will focus specifically on (1) adenocarcinoma tumors that do not carry a mutation in a known cancer gene (EGFR, KRAS, or ALK) and occur in patients that never smoked (less than 100 cigarettes in their lifetime) or (2) adenocarcinoma tumors that have a mutation in the RET gene.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started May 2013

Typical duration for phase_2 lung-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 4, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

4.3 years

First QC Date

April 9, 2013

Results QC Date

January 30, 2018

Last Update Submit

October 3, 2018

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria.

    ORR was assessed at 6 weeks post-registration and every 6 weeks until date of documented disease progression or death, up to January 23, 2017 (approximately 44 months).

Study Arms (1)

Sunitinib

EXPERIMENTAL

42 day cycle, taken orally every day for the first 28 days followed by 14 days off

Drug: Sunitinib

Interventions

SunitinibDRUG
Sunitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed advanced (stage IV or recurrent) non-small cell lung cancer
  • Adenocarcinoma histology of any variant, including adenosquamous histology
  • Wild-type for mutations in EGFR, KRAS and ALK
  • Must have \< 100 cigarettes smoked lifetime OR known to harbor a RET rearrangement OR another potentially targetable genomic alteration as defined per protocol
  • Disease must be measureable per RECIST 1.1
  • At least one prior systemic therapy (adjuvant or palliative)
  • years or older
  • Life expectancy of greater than 4 weeks
  • Adequate ECOG performance status 0 or 1
  • Adequate organ function as defined in the protocol
  • Adequate tumor tissue for the correlative analyses on study, or must undergo a biopsy to obtain adequate tissue

You may not qualify if:

  • Pregnant or breastfeeding
  • Chemotherapy within 4 weeks of entering study, or lack of recover from adverse events to grade 1 or less due to systemic agents administered more than 4 weeks earlier
  • Radiation therapy within 2 weeks prior to entering study
  • Major surgery within 4 weeks prior to entering the study
  • Receiving any other investigational agents
  • Known untreated, symptomatic or progressive brain metastases; presence of carcinomatous meningitis; history of intracranial hemorrhage or brain metastases requiring chronic steroids
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib
  • Use of certain inhibitors and inducers of CYP3A4
  • Grade 3 or 4 hemoptysis or hemorrhage within 4 weeks prior to study entry
  • History of significant bleeding disorder unrelated to cancer
  • Poorly controlled hypertension
  • Severe cardiovascular disease
  • Prolongation of corrected QT interval
  • History of a different malignancy except: cervical cancer in situ, basal or squamous cell carcinoma of the skin, low risk centralized prostate cancer
  • HIV positive on combination antiretroviral therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • Cooper AJ, Kobayashi Y, Kim D, Clifford SE, Kravets S, Dahlberg SE, Chambers ES, Li J, Rangachari D, Nguyen T, Costa DB, Rabin MS, Wagle N, Sholl LM, Janne PA, Oxnard GR. Identification of a RAS-activating TMEM87A-RASGRF1 Fusion in an Exceptional Responder to Sunitinib with Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Aug 1;26(15):4072-4079. doi: 10.1158/1078-0432.CCR-20-0397. Epub 2020 Apr 20.

    PMID: 32312893DERIVED

  • Wu H, Shih JY, Yang JC. Rapid Response to Sunitinib in a Patient with Lung Adenocarcinoma Harboring KIF5B-RET Fusion Gene. J Thorac Oncol. 2015 Sep;10(9):e95-e96. doi: 10.1097/JTO.0000000000000611. No abstract available.

    PMID: 26291023DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

This study was closed to accrual due to slow enrollment.

Results Point of Contact

Title
Principal Investigator: Geoffrey Oxnard, MD
Organization
Dana-Farber Cancer Institute
geoffrey_oxnard@dfci.harvard.edu
617-632-6049

Study Officials

  • Geoffrey Oxnard, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2017

Study Completion

January 1, 2018

Last Updated

October 31, 2018

Results First Posted

September 4, 2018

Record last verified: 2018-10

Locations

US(4)