NCT01377298

Brief Summary

Because of the advantageous activity against VEGF-C and FGF pathways and favorable toxicity profile comparing with sunitinib, the investigators plan this phase II trial of pazopanib in cisplatin-refractory recurrent or metastatic HNSCC.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

May 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

1.9 years

First QC Date

May 16, 2011

Last Update Submit

June 20, 2011

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Evaluable for response: From the RECIST 1.1 paper,all patients included in the study must be accounted for in the results, even if there are major protocol treatment deviations or if they are not evaluable.

    1 year

Secondary Outcomes (4)

  • disease control rate (CR+PR+SD),

    1 year

  • Tumor Necrosis Ratio

    1 year

  • progression-free survival

    1 year

  • overall survival

    1 year

Study Arms (1)

Pazopanib

EXPERIMENTAL

Single arm study, pazopanib

Drug: Pazopanib

Interventions

PazopanibDRUG

200mg/tablet, 800mg/day PO.

Pazopanib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed HNSCC.
  • Recurrent or metastatic setting, refractory to previous cisplatin or carboplatin-based chemotherapy.
  • At least one measurable lesion (according to RECIST v 1.1 criteria).
  • Eastern Cooperative Oncology Group performance status 0 to 2.
  • Age\>18y/o,\<=70y/o.
  • Adequate bone marrow, hepatic, and renal functions as evidenced by the following:
  • Absolute neutrophil count\>=1,500 cells/L, platelet count\>=100,000 cells/L, and hemoglobin\>=9 g/dL.
  • Total bilirubin\<=1.5 X ULN, AST/ALT\<=3.0 X ULN
  • Creatinine\<=1.5 mg/dL.
  • Informed consent, obtained in writing.

You may not qualify if:

  • Second malignancy.
  • Locoregional recurrence amenable to definite surgery or radiation again.
  • Brain/meningeal metastasis with IICP or bone metastasis with spinal cord compression.
  • Pregnancy or nursing women.
  • Having received more than two prior lines of intravenous chemotherapy in the palliative setting.
  • Having received antiangiogenesis agent in the palliative setting.
  • Having received chemotherapy or radiation therapy or surgery within 3 weeks.
  • Major systemic diseases those are inappropriate for systemic chemotherapy according to clinician's professional judgment.
  • Mental status not fit for clinical trials.
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
  • Active peptic ulcer disease
  • Known intraluminal metastatic lesion/s with risk of bleeding
  • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
  • Corrected QT interval (QTc)\>480 msecs using Bazett's formula.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Study Officials

  • Ruey-Long Hong, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruey-Long Hong, MD

CONTACT

+886 2 23123456rlhong@ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2011

First Posted

June 21, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2014

Last Updated

June 21, 2011

Record last verified: 2011-06

Locations

TW(1)