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

NCT ID: NCT01380769

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-10-31

Brief 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).

Detailed 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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRLX101

Group Type: EXPERIMENTAL

CRLX101

Intervention Type: DRUG

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

Best supportive care

Group Type: OTHER

Best Supportive Care

Intervention Type: OTHER

best supportive care

Interventions

CRLX101

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

Intervention Type: DRUG

Best Supportive Care

best supportive care

Intervention Type: OTHER

Other Intervention Names

NLG207

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NewLink Genetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

NewLink Genetics

Role: STUDY_CHAIR

NewLink Genetics Inc

Locations

State Medical Institution Republican Oncology Center

Saransk, Respublika Mordoviya, Russia

State Medical Institution Republic Clinical Oncological Center under the Healthcare Ministry of Tatarstan Republic

Kazan', Tatarstan Republic, Russia

Arkhangelsk Regional Clinical Oncology Center

Arkhangelsk, , Russia

State Healthcare Institution: Bryansk Regional Oncology Center

Bryansk, , Russia

Chelyabinsk Regional Clinical Oncology Center

Chelyabinsk, , Russia

Kursk Regional Oncology Center

Kursk, , Russia

Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center

Moscow, , Russia

Non-Government Medical Institution: Central Clinical Hospital #2

Moscow, , Russia

State Healthcare Institution of Nizhny Novgorod Regiona Nizhny Novgorod Oncology Center

Nizhny Novgorod, , Russia

City Clinical Hospital #1

Novosibirsk, , Russia

State Medical Institution: Pyatigorsk Oncological Center

Pyatigorsk, , Russia

St. Petersburg Medical University

Saint Petersburg, , Russia

City Clinical Oncology Center

Saint Petersburg, , Russia

Stavropol Regional Clinical Oncology Center

Stavropol, , Russia

Tambov Regional Oncology Center

Tambov, , Russia

Primorsky Regional Oncology Center

Vladivostok, , Russia

Regional Clinical Oncology Center

Yaroslavl, , Russia

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

Uzhhorod, , Ukraine

Countries

Russia; Ukraine

Other Identifiers

CRLX-002

Identifier Type: -

Identifier Source: org_study_id