Trial record 2 of 7 for:    cerulean

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cerulean Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01380769
First received: June 22, 2011
Last updated: July 9, 2014
Last verified: September 2013
  Purpose

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).


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: CRLX101
Other: Best Supportive Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cerulean Pharma Inc.:

Primary Outcome Measures:
  • To compare overall survival of patients treated with CRLX101 to those patients treated with best supportive care. [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess response rate of CRLX101 compared to BSC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Compare Changes in quality of like (as determined by a self-administered quality of life questionnaire) in patients receiving CLRX101 vs. BSC [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 148
Study Start Date: June 2011
Estimated Study Completion Date: September 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRLX101 Drug: CRLX101
CRLX101 is administered at 15mg/m2 IV every other week
Best supportive care Other: Best Supportive Care
best supportive care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380769

Locations
Russian Federation
State Medical Institution Republican Oncology Center
Saransk, Republic of Mordovia, Russian Federation, 430032
State Medical Institution Republic Clinical Oncological Center under the Healthcare Ministry of Tatarstan Republic
Kazan, Republic of Tatarstan, Russian Federation, 420029
Arkhangelsk Regional Clinical Oncology Center
Arkhangelsk, Russian Federation, 163045
State Healthcare Institution: Bryansk Regional Oncology Center
Bryansk, Russian Federation, 241033
Chelyabinsk Regional Clinical Oncology Center
Chelyabinsk, Russian Federation, 454087
Kursk Regional Oncology Center
Kursk, Russian Federation, 305035
Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center
Moscow, Russian Federation, 115478
Non-Government Medical Institution: Central Clinical Hospital #2
Moscow, Russian Federation, 129128
State Healthcare Institution of Nizhny Novgorod Regiona Nizhny Novgorod Oncology Center
Nizhny Novgorod, Russian Federation, 603081
City Clinical Hospital #1
Novosibirsk, Russian Federation, 630047
State Medical Institution: Pyatigorsk Oncological Center
Pyatigorsk, Russian Federation, 357500
St. Petersburg Medical University
St. Petersburg, Russian Federation, 197022
City Clinical Oncology Center
St. Petersburg, Russian Federation, 198255
Stavropol Regional Clinical Oncology Center
Stavropol, Russian Federation, 355047
Tambov Regional Oncology Center
Tambov, Russian Federation, 392013
Primorsky Regional Oncology Center
Vladivostok, Russian Federation, 690105
Regional Clinical Oncology Center
Yaroslavl, Russian Federation, 150054
Ukraine
Dnipropetrovsk State Medical Academy
Dnipropetrovsk, Ukraine, 49102
Public Treatment and Prophylaxis Institution; Donetsk Regional Antitumor Center
Donetsk, Ukraine, 83092
Ivano-Frankovsk State Medical University; Oncology Department Clinical Facility
Ivano-Frankivsk, Ukraine, 76000
Kharkiv State Public Healthcare Institution: Kharkiv Regional Clinical Oncology Center
Kharkiv, Ukraine, 61070
Khmelnytskyi Regional Oncology Center
Khmelnytsky, Ukraine, 29009
Kyiv City Oncology Hospital
Kyiv, Ukraine, 03115
Sumy Regional Clinical Oncology Center
Sumy, Ukraine, 40005
Zakarpattia Regional Clinical Oncology Center
Uzhgorod, Ukraine, 88011
Sponsors and Collaborators
Cerulean Pharma Inc.
Investigators
Study Chair: Cerulean Pharma Cerulean Pharma Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Cerulean Pharma Inc.
ClinicalTrials.gov Identifier: NCT01380769     History of Changes
Other Study ID Numbers: CRLX-002
Study First Received: June 22, 2011
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 11, 2014