A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT02389985|
Recruitment Status : Terminated (Company decision)
First Posted : March 17, 2015
Last Update Posted : May 23, 2019
The purpose of this study is to estimate the maximum tolerated doses (MTD) of CRLX101 when administered in combination with weekly paclitaxel in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.
Determine through pharmacokinetic evaluation(sometimes described as what the body does to a drug, refers to the movement of drug into, through and out of the body-the time and course of its absorption, bioavailability, distribution, metabolism, and excretion) whether or not the disposition of paclitaxel is affected by the concurrent administration of CRLX101.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: CRLX101 Drug: Paclitaxel||Phase 1 Phase 2|
Recurrent ovarian cancer represents a therapeutic challenge. Patients with resistant disease, showing progression within six months of platinum-containing therapy, have a poor prognosis, with median overall survival (OS) approximately 12 months.Ultimately most patients with recurrent disease ultimately develop platinum resistance, and novel strategies are needed.
In this setting the most active agents are pegylated liposomal doxorubicin (PLD), paclitaxel and topotecan. Multiple trials have demonstrated that combination therapy produces increased toxicity without improved efficacy.
This study proposes to examine the combination of CRLX101 in combination with weekly paclitaxel. Preclinical studies show synergistic activity in the SKOV3 human ovarian cancer xenograft ovarian cancer cell lines (14), as well as in vivo (15,16), perhaps via an antiangiogenic mechanism.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Study of CRLX101 in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||June 4, 2018|
|Actual Study Completion Date :||October 18, 2018|
Experimental: CRLX101 and weekly paclitaxel
CRLX101 and weekly paclitaxel administered by IV on days 1 and 15 of a 28 day cycle. Paclitaxel only is administered by IV on day 8.
Other Name: NLG207
Other Name: Taxol
- 1. To estimate the maximum tolerated doses (MTD) of CRLX101 when administered in combination with weekly paclitaxel in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer. [ Time Frame: 6 months ]The highest dose with <2 patients with DLTs out of 6 DLT-evaluable patients
- Comparison of pharmacokinetic perimeters including max concentration (Cmax), time to maximum concentration (Tmax), AUC, elimination half-life for CRLX101 and paclitaxel [ Time Frame: 6 months ]PK
- 2. To assess the overall safety and tolerability of CRLX101 in combination with weekly paclitaxel. [ Time Frame: 6 months ]AEs, changes in clinical status, vital signs, and laboratory data
- To assess the anti-tumor activity of CRLX101 when administered concomitantly with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian fallopian tube or primary peritoneal cancer. [ Time Frame: 6 months ]PFS per RECIST 1.1 with scans every 2 cycles
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389985
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Oklahoma|
|University of Oklahoma / Stephenson Cancer Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Rhode Island|
|Women & Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02095|
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22901|