A Randomized Phase 2 Study of AT-101 in Combination With Docetaxel in Relapsed/Refractory Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 2, Randomized, 2-Arm, Double-Blind Study of AT-101 in Combination With Docetaxel Versus Docetaxel Plus Placebo in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544960
• Other study ID #: AT-101-CS-204
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2007
• Last updated: August 24, 2010
• Start date: September 2007
• Est. completion date: April 2009

Study information

• Verified date: August 2010
• Source: Ascenta Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a double- blind, multicenter, randomized Phase II study to evaluate the efficacy and safety of AT-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer

Description:

Further Study Details provided by Ascenta.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed Stage IIIb with pleural/pericardial effusion or Stage IV non-small cell lung cancer (NSCLC).

• Progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic NSCLC. (Systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) In addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting.

• All patients must have measurable disease.

• No unstable or progressive brain metastases.

• Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.

• ECOG performance status 0-1

• Adequate hematologic function

• Adequate liver and renal function

• Ability to swallow oral medication

Exclusion Criteria:

• Prior chemotherapy regimen containing docetaxel.

• Active secondary malignancy.

• Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.

• Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• AT-101 and docetaxel
AT-101 30 mg bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops
• placebo and docetaxel
placebo 3 tabs bid on days 1, 2, and 3 of each 21 day cycle, docetaxel, 75 mg/m2 on day 1 of each 21 day cycle; until progression or unacceptable toxicity develops

Locations

Country	Name	City	State
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Kaliningrad
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Sites (4)	Saint Petersburg
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Stavropol
Russian Federation	Research Site	Voronezh
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lugansk
Ukraine	Research Site	Uzhgorod
Ukraine	Research Site	Zaporizhzhya
United States	Research Site	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ascenta Therapeutics

Countries where clinical trial is conducted

United States,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of disease remission		12 months	No
Secondary	number of participants with adverse events		12 months	No