An Open-label, Phase I Trial of Intravenous ASA404 Administered in Combination With Paclitaxel and Carboplatin in Japanese Patients With Non-Small Cell Lung Cancer (NSCLC)

NCT00674102 | Completed Phase 1

• 1 other identifier: CASA404A1101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

The safety, tolerability, efficacy and pharmacokinetics of ASA404 when administered in combination with paclitaxel and Carboplatin are assessed. ASA404 is administered intravenously every 21 days to Japanese patients with Non small cell lung cancer.

Conditions

Non-small Cell Lung Cancer

Keywords

Vascular disrupting agent; Non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• To assess the safety profile and tolerability of ASA404 when administered in combination with paclitaxel and carboplatin in Japanese patients with non small cell lung cancer

  First cycle

Secondary Outcomes (1)

• To characterize the pharmacokinetics profile of ASA404 in Japanese patients

  every 2 cycles

Study Arms (1)

ASA404

EXPERIMENTAL

Drug: ASA404

Interventions

ASA404 DRUG

ASA404

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed non-small cell carcinoma of the lung.
• Newly diagnosed Stage IIIb disease or Stage IV disease
• No prior treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Note: Prior neoadjuvant or adjuvant chemotherapy within 6 months is allowed.)
• Age ≥ 20 years old
• WHO Performance status of 0-1
• Lab values within the range as defined below within 2 weeks of study registration (Note: without the use of growth factors or blood transfusions):
• Absolute neutrophil count (ANC) \> 2.0 x 109/L
• Platelets ≥ 100 x109/L
• Hemoglobin ≥ 9.5 g/dL
• Serum creatinine ≤ 1.5 x ULN or 1.5 mg/dL
• Serum bilirubin ≤ 1.5 x ULN
• Aspartate transaminase (AST) and alanine transaminase (ALT)
• ≤ 2.5 x ULN
• PT-INR ≤ 1.5 x ULN
• Potassium ≥ LLN or correctable with supplements.

You may not qualify if:

• Patients having symptomatic CNS metastases and requiring treatment
• Patients with second primary cancer, with the exception of non-melanoma skin cancer or cervical cancer in situ.
• Radiotherapy ≤ 4 weeks prior to registration (In case of palliative radiotherapy 2 weeks prior to registration
• Major surgery ≤ 4 weeks prior to registration (major surgery is defined by the use of general anesthesia). Minor surgery ≤ 2 weeks prior to registration. Insertion of a vascular access device is allowed. Patients must have recovered from all surgery-related complications.
• Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to registration
• Prior exposure to VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents
• Patients with pleural effusion to be drained (Patients who have recurrence of pleural effusion and/or it takes 2 weeks before registration after drainage are allowed)
• Patients with recent hemoptysis associated with NSCLC (\>1 teaspoon in a single episode within 4 weeks)
• Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of these drugs.
• Peripheral sensory neuropathy with functional impairment (CTC Grade 2 neuropathy, regardless of causality)
• ≥ CTC Grade 2 cardiac arrhythmias (i.e. symptomatic, but may not require medications).
• Pregnant or breast feeding females
• Patients who take medicine that are known to prolong the QT interval
• Women of child bearing potential or sexually active males, unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment. (Adequate forms of contraception include IUD, oral or depot contraceptive or the barrier method plus spermicide.)
• Patients with any one of the following

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Aichi, Japan

Location

Novartis Investigative Site

Osaka, Japan

Location

Novartis Investigative Site

Shizuoka, Japan

Location

Novartis Investigative Site

Tokyo, Japan

Location

Related Links

• Results for CASA404A1101 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

vadimezan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Last Updated: December 9, 2020

Record last verified: 2016-04

Locations

JP (4)