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A Phase I, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administrated Every 3 Weeks in Chinese Patients With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasm Malignant

Thank you

Trial Information

A Phase I, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administrated Every 3 Weeks in Chinese Patients With Advanced Solid Malignancies


The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and
90 days after the last aflibercept administration. Patients will be administered aflibercept
in combination with docetaxel until when/if a definitive treatment discontinuation criterion
is met such as progressive disease, unacceptable toxicity or patient refusal to continue.

Inclusion Criteria


Inclusion criteria :

- Histologically or cytologically confirmed solid malignancy that metastatic or
unresectable for which standard curative measures do not exist, but for which
docetaxel treatment is appropriate.

Exclusion criteria :

- Squamous histology/cytology lung cancer

- Need for a major surgical procedure or radiation therapy during the study

- Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an
investigational agent within 28 days

- Cumulative radiation therapy to >25% of the total bone marrow

- History of brain metastases

- Eastern Cooperative Oncology Group(ECOG)>1

- Prior docetaxel treatment but have not been appropriate for safety reasons

- Inadequate organ and bone marrow function

- Uncontrolled hypertension

- Evidence of clinically significant bleeding diathesis or underlying coagulopathy

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-Limiting Toxicity (DLT)

Outcome Time Frame:

3 weeks (cycle 1)

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

China: Ethics Committee

Study ID:

TCD11382

NCT ID:

NCT01148615

Start Date:

July 2010

Completion Date:

December 2011

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms

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