A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT02389985 | Terminated Phase 1

• 1 other identifier: CRLX101-209
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  The highest dose with \<2 patients with DLTs out of 6 DLT-evaluable patients

  6 months

Secondary Outcomes (1)

• Comparison of pharmacokinetic perimeters including max concentration (Cmax), time to maximum concentration (Tmax), AUC, elimination half-life for CRLX101 and paclitaxel

  6 months

Other Outcomes (2)

• 2. To assess the overall safety and tolerability of CRLX101 in combination with weekly paclitaxel.

  6 months

• 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.

  6 months

Study Arms (1)

CRLX101 and weekly paclitaxel

EXPERIMENTAL

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.

Drug: CRLX101; Drug: Paclitaxel

Interventions

CRLX101 DRUG

Also known as: NLG207

CRLX101 and weekly paclitaxel

Paclitaxel DRUG

Also known as: Taxol

CRLX101 and weekly paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report.
• Patient must have measurable disease or detectable (non-measurable) disease:
• Measurable disease will be defined by RECIST 1.1.
• Patients must have adequate bone marrow, renal, hepatic, and neurologic functions
• Patients should be free of active infection requiring parenteral antibiotics.
• Any other prior therapy directed at the malignant tumor, including chemotherapy, bevacizumab or other biologic or targeted agents and immunologic agents, must be discontinued at least 21 days (three weeks) prior to registration.
• Any prior radiation therapy must be discontinued at least four weeks prior to registration.
• Major surgery within 28 days (four weeks) prior to registration.
• Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease.
• Patients must have a GOG performance status of 0 or 1.
• Patients who will be enrolled under protocol amendment # 2 must have previously received bevacizumab, either discontinued due to intolerability, or progressed after at least 2 cycles of bevacizumab

You may not qualify if:

• Patients who have had previous treatment with:
• CRLX101 or with any topoisomerase I therapy;
• Weekly paclitaxel for recurrent or persistent disease.
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin, are excluded if:
• There is any evidence of other malignancy being present within the last three years;
• Previous cancer treatment contraindicates this protocol therapy.
• Patients with known active hepatitis or HIV.
• Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first dose of study drug.
• Patients with clinically significant cardiovascular disease.
• Patients with serous non-healing wound, ulcer, or bone fracture.
• Patients with active bleeding or pathologic conditions that carry high risk of bleeding
• Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition.
• Patients with active infection requiring parenteral antibiotics.

Sponsors & Collaborators

• NewLink Genetics Corporation: lead

Study Sites (7)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Oklahoma / Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02095, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22901, United States

Location

Related Publications (1)

• Duska LR, Krasner CN, O'Malley DM, Hays JL, Modesitt SC, Mathews CA, Moore KN, Thaker PH, Miller A, Purdy C, Zamboni WC, Lucas AT, Supko JG, Schilder RJ. A phase Ib/II and pharmacokinetic study of EP0057 (formerly CRLX101) in combination with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Gynecol Oncol. 2021 Mar;160(3):688-695. doi: 10.1016/j.ygyno.2020.12.025. Epub 2020 Dec 31.

  PMID: 33390325 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

IT-101; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 17, 2015
• Study Start: July 1, 2015
• Primary Completion: June 4, 2018
• Study Completion: October 18, 2018
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

US (7)