A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Phase 2, Study to Assess the Safety and Activity of CRLX101, a Nanoparticle Formulation of Camptothecin, in Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed One or Two Previous Regimens of Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380769
• Other study ID #: CRLX-002
• Status: Completed
• Phase: Phase 2
• Start date: June 2011
• Est. completion date: October 2014

Study information

• Verified date: May 2020
• Source: Lumos Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare median overall survival of patients with advanced non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best supportive care (BSC).

Description:

Lung cancer remains the leading cause of cancer-related mortality in men and women worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer. The development of targeted therapies has changed the approach to treating NSCLC significantly over the past decade with targeted therapies generally possessing safety advantages over traditional cytotoxic regimens. However, combination paradigms and resistance patterns complicate the use of these agents. CRLX101 is a nanoparticle comprised of camptothecin (CPT) conjugated to a cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: October 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients who are = 18-years of age.

• Histologically or cytologically confirmed, locally advanced or metastatic NSCLC (adenocarcinoma, bronchoalveolar, squamous cell, large cell, or mixed carcinoma) that is not amendable to surgical treatment and patient has have failed 1 or 2 different lines of chemotherapy.

• Measureable disease and evidence of progression on the previous therapy. Progression may be clinical or radiological.

• ECOG performance status of 0 or 1.

• Life expectancy of at least 3 months.

• Hemoglobin = 10 g/dL.

• Absolute neutrophil count (ANC) = 1500 cells/µL without growth factor support.

• Platelet count = 100,000 cells/µL without support.

• Adequate hepatic and renal function including the following: Total bilirubin < 2 × ULN, AST or ALT = 2.5 × ULN or = 5 × ULN for patients with liver metastasis, PTT within normal limits, INR = 1.5, Serum Creatinine <1.5 ULN

• At least 4 weeks post any radiotherapy or biological therapy; at least 6 weeks post nitrosoureas therapy.

• Full recovery from diagnostic or therapeutic surgery (i.e., complete wound healing) and at least 30 days have elapsed prior to initial dosing.

• Full recovery from the toxic effects of prior therapy (i.e., Common Toxicity Criteria [CTC] Grade 1 or less with the exception of Grade 2 alopecia).

• Women of childbearing potential must have adequate pregnancy test. If postmenopausal, must be = 12 months since last menses.

• Women of childbearing potential and men must agree to use an effective form of contraception during the study and for 60 days after the last dose of study drug.

Exclusion Criteria:

• CNS metastases by radiologic evidence or histology, unless clinically stable (must have been treated by resection or radiation) for at least 4 weeks prior to first dose of study drug. Patients may not be receiving dexamethasone for control of CSF pressure.

• Concurrent therapeutic anticoagulation: PTT less than or equal to 1.5 × ULN or low dose aspirin and low-weight heparin only are allowed.

• More than 2 previous lines of chemotherapy for lung cancer. This includes biologic (immunotherapy) therapy.

• History of previous cerebrovascular accident (CVA) or history transient ischemic attack (TIA) within 6 months of study entry.

• History of prior malignancy not cured by excision. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least 2-year disease free interval.

• Recent history (within 6 months of screening) of unstable angina, myocardial infarction, or NYHA Class III or IV congestive heart failure

• History of cardiac arrhythmia requiring medical or electrical therapy.

• QTc > 450 msec for males and > 470 msec for females.

• Any major surgery within 30 days or minor surgery within 10 days of study entry, or patient not recovered from surgery.

• History of organ or bone marrow transplant.

• Known active and/or uncontrolled infection, including HIV and are not stable on antiretroviral therapy.

• Any investigational therapy within 28 days of study entry.

• Pregnant or nursing.

• Anyone who in the judgment of the investigator cannot comply with the protocol, provide truly informed consent, or is likely to live < 90 days

• Severe or significant allergy to any chemotherapy or premedication.

• Clinically evident ascites (e.g., abdominal distention, bulging and/or fluid wave) or Grade 3 peripheral edema.

• Any prior cancer treatment with a topoisomerase I inhibitor.

Related Conditions & MeSH terms

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

Intervention

Drug:
• CRLX101
CRLX101 is administered at 15mg/m2 IV every other week

Other:
• Best Supportive Care
best supportive care

Locations

Country	Name	City	State
Russian Federation	Arkhangelsk Regional Clinical Oncology Center	Arkhangelsk
Russian Federation	State Healthcare Institution: Bryansk Regional Oncology Center	Bryansk
Russian Federation	Chelyabinsk Regional Clinical Oncology Center	Chelyabinsk
Russian Federation	State Medical Institution Republic Clinical Oncological Center under the Healthcare Ministry of Tatarstan Republic	Kazan	Republic Of Tatarstan
Russian Federation	Kursk Regional Oncology Center	Kursk
Russian Federation	Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center	Moscow
Russian Federation	Non-Government Medical Institution: Central Clinical Hospital #2	Moscow
Russian Federation	State Healthcare Institution of Nizhny Novgorod Regiona Nizhny Novgorod Oncology Center	Nizhny Novgorod
Russian Federation	City Clinical Hospital #1	Novosibirsk
Russian Federation	State Medical Institution: Pyatigorsk Oncological Center	Pyatigorsk
Russian Federation	State Medical Institution Republican Oncology Center	Saransk	Republic Of Mordovia
Russian Federation	City Clinical Oncology Center	St. Petersburg
Russian Federation	St. Petersburg Medical University	St. Petersburg
Russian Federation	Stavropol Regional Clinical Oncology Center	Stavropol
Russian Federation	Tambov Regional Oncology Center	Tambov
Russian Federation	Primorsky Regional Oncology Center	Vladivostok
Russian Federation	Regional Clinical Oncology Center	Yaroslavl
Ukraine	Dnipropetrovsk State Medical Academy	Dnipropetrovsk
Ukraine	Public Treatment and Prophylaxis Institution; Donetsk Regional Antitumor Center	Donetsk
Ukraine	Ivano-Frankovsk State Medical University; Oncology Department Clinical Facility	Ivano-Frankivsk
Ukraine	Kharkiv State Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center	Kharkiv
Ukraine	Khmelnytskyi Regional Oncology Center	Khmelnytsky
Ukraine	Kyiv City Oncology Hospital	Kyiv
Ukraine	Sumy Regional Clinical Oncology Center	Sumy
Ukraine	Zakarpattia Regional Clinical Oncology Center	Uzhgorod

Sponsors (1)

Lead Sponsor	Collaborator
NewLink Genetics Corporation

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only	Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.	Up to 18 months
Secondary	Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only	Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.	12 months

External Links

•   Related Info