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Study of CRLX101 (Formerly Named IT-101) in the Treatment of Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerulean Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00333502
First received: June 1, 2006
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

CRLX101 is a nanopharmaceutical comprised of the chemotherapeutic camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.

OBJECTIVES:

• Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CRLX101 when administered intravenously to subjects with advanced solid tumors.


Condition Intervention Phase
Cancer
Solid Tumor
Drug: Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Safety and Pharmacokinetic Study of CRLX101 (Formerly Named IT-101) in the Treatment of Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Cerulean Pharma Inc.:

Primary Outcome Measures:
  • To determine the safety, toxicity and maximum tolerated dose of CRLX101 when administered intravenously to subjects with advanced solid tumors. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: May 2006
Study Completion Date: April 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRLX101 (formerly known as IT-101)
CRLX101 dosing per protocol dose escalation cohorts to MTD, then expansion cohort treated at MTD of CRLX101 15mg/m2
Drug: Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer
Subjects who meet inclusion/exclusion criteria will receive CRLX101 every other week.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects >18 years of age with advanced, histologically-confirmed solid tumors refractory to standard therapy or for which no standard therapy exists and who have evidence of disease progression documented since their prior therapy.
  • Subjects must have measurable or evaluable disease.
  • Subjects must not have received prior chemotherapy or radiation for >/= 4 weeks prior to first dose of study drug.
  • Subjects may be entered if they have received prior radiation therapy involving </= 30% of the bone marrow. Any prior radiation therapy must have been administered >/= 4 weeks prior to first dose of study drug and the subject must be recovered from the acute toxic effects of the treatment prior to study entry.
  • Subjects may be enrolled with a history of treated brain metastases that are clinically stable for >/= 4 weeks prior to first dose of study drug. Subjects may not be currently receiving dexamethasone.
  • ECOG performance status of < 2.
  • Life expectancy of greater than 12 weeks.
  • Subjects must have acceptable organ and marrow function at screening and pre-dose visits.
  • Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator and an acceptable QTc interval.
  • The effects of CRLX101 on the developing human fetus are unknown, therefore, women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Female subjects who are pregnant or nursing.
  • Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first dose of study drug or those who have not had adverse events return to baseline severity level or a severity level Grade 1 due to agents administered more than 4 weeks prior to first dose of study drug.
  • Subjects with a history of congestive heart failure (CHF) requiring medical therapy.
  • Subjects with serum amylase or lipase > 1.5X upper limit of normal (ULN).
  • Subjects with previous high dose chemotherapy with autologous stem cell rescue bone marrow transplantation.
  • Use of any investigational agent or drug within 4 weeks prior to first dose of study drug.
  • Metastatic disease to the CNS requiring treatment or radiation therapy.
  • Subjects with known untreated brain metastases or treated brain metastases that have not been stable >/= 4 weeks prior to first dose of study drug.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.
  • The presence of active coagulation disorder.
  • Subjects with marked baseline prolongation of QT/QTc interval (QTc interval >/= 470 msec for females and QTc interval >/= 450 msec for males).
  • Any prior treatment with a topoisomerase I inhibitor.
  • Any major surgery </= 4 weeks prior to first dose of study drug.
  • Concurrent use of G-CSF or growth factors at the time of initiation of study drug.
  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: NCT00333502

Locations
United States, Arizona
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States, 85258
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, New Mexico
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
Sponsors and Collaborators
Cerulean Pharma Inc.
Investigators
Principal Investigator: Yun Yen, M.D., Ph.D. City of Hope National Medical Center
Principal Investigator: Glenn Weiss, M.D. Virginia G. Piper Cancer Center
Principal Investigator: Jeffrey D. Neidhart, M.D. San Juan Oncology Associates
  More Information

Additional Information:
Publications:
Responsible Party: Cerulean Pharma Inc.
ClinicalTrials.gov Identifier: NCT00333502     History of Changes
Other Study ID Numbers: CRLX-001, City of Hope IRB number 05127
Study First Received: June 1, 2006
Last Updated: July 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerulean Pharma Inc.:
Cancer, Neoplasms, Solid Tumor, Ovarian Cancer, Lung Cancer,
Non Small Cell Lung Cancer, Pancreatic Cancer,
Breast Cancer, Colon Cancer, Endometrial Cancer,
Kidney (Renal Cell) Cancer, Melanoma, Prostate Cancer,
Skin Cancer, Thyroid Cancer,
Solid Malignancies

Additional relevant MeSH terms:
Neoplasms
Camptothecin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014