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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

June 1, 2006
July 30, 2012
May 2006
November 2011   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00333502 on ClinicalTrials.gov Archive Site
Not Provided
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Study of CRLX101 (Formerly Named IT-101) in the Treatment of Advanced Solid Tumors
A Phase 1b/2a Safety and Pharmacokinetic Study of CRLX101 (Formerly Named IT-101) in the Treatment of Advanced Solid Tumors

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Solid Tumor
Drug: Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer
Subjects who meet inclusion/exclusion criteria will receive CRLX101 every other week.
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
Intervention: Drug: Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
April 2012
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00333502
CRLX-001, City of Hope IRB number 05127
Not Provided
Cerulean Pharma Inc.
Cerulean Pharma Inc.
Not Provided
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
Cerulean Pharma Inc.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP