Phase 1/2a/3 Evaluation of Adding AL3818 to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma (AL3818-US-002)

Status unconfirmed · Phase 3

Conditions studied: Endometrial Carcinoma, Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Cervical Carcinoma

In brief

This trial is a Phase 1b/2a/3 trial designed to evaluate the safety and efficacy of adding oral AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to standard platinum-based chemotherapy concurrently in Subjects with Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma.

Key facts

Study ID

NCT02584478

Run by

Advenchen Laboratories, LLC

People needed

294

Starts

2015-12-01

Expected to finish

2024-12-01

Last updated by the study team

2023-11-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Serious, non-healing wound, ulcer or bone fracture.
• Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to C1D1 (a major surgical procedure is defined as requiring general anesthesia).
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• Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
• History or evidence upon physical examination of central nervous system (CNS) disease including primary brain tumor; seizures not controlled with standard medical therapy; and history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within 6 months of enrollment.
• a. Subjects with metastatic CNS tumors may participate in this study if the subject is > 28 days from therapy completion (including radiation and/or surgery), is clinically stable at the time of study enrollment, and is not receiving corticosteroid therapy.
• Proteinuria on urinalysis within 28 days of enrollment. Subjects discovered to have a urine protein of 1+ on dipstick or ≥ 30 mg/dl at baseline should undergo a 24-hour urine collection and demonstrate < 1000 mg protein per 24 hours or spot urine protein (mg/dL) to creatinine (mg/dL) ratio must be <1.0 to allow participation in the study.
• Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure (Appendix E); serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease.
• Women who are pregnant or nursing.
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• Clinically significant, uncontrolled hypokalemia, hypomagnesaemia, and/or hypocalcaemia.
• Hemoptysis within 3 months prior to enrollment.
• Acute or chronic liver disease, active hepatitis A or B with known cirrhosis or liver dysfunction.
• Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 28 days (42 days in cases of mitomycin C, nitrosourea, lomustine) prior to enrollment.
• Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.
• Known history of human immunodeficiency virus infection (HIV).
• Active bacterial infections requiring systemic antibiotics (excluding uncomplicated urinary tract infection).
• Other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years prior to enrollment or whose previous cancer treatment contraindicates this protocol therapy.
• History of non-malignant gastrointestinal bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months prior to enrollment that in the opinion of the investigator may place the subject at risk of side effects on an anti-angiogenesis product.
• History of significant vascular disease (e.g. aortic aneurysm, aortic dissection).
• Intra-abdominal abscess within the last 3 months of enrollment.
• Pre-existing uncontrolled hypertension as documented by two baseline blood pressure readings taken at least five minutes apart, defined as systolic BP >160 mm Hg or diastolic BP > 90 mm Hg pressure.
• QTc > 470 msec on screening ECG per Fridericia's formula.
• History of or existing risk factors for Torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
• Concurrent use of concomitant medications that prolong the QT/QTc interval.

Where it is running

• The Oncology Institute of Hope and Innovation — Long Beach, California, United States
• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Baptist Health Lexington Oncology Research — Lexington, Kentucky, United States
• Washington University — St Louis, Missouri, United States
• Montefiore Medical Center — The Bronx, New York, United States
• AHN West Penn Hospital — Pittsburgh, Pennsylvania, United States
• UTSW — Dallas, Texas, United States
• University of Wisconsin Madison — Madison, Wisconsin, United States
• Henan Cancer Hospital — Hefei, Henan, China
• Jilin Cancer Hospital — Changchun, Jilin, China
• The First Hospital of China Medical University — Shenyang, Shenyang, China
• Zhongda Hospital Southeast University — Chongqing, Sichuan, China
• Tianjin Central Hospital of Gynecology Obstetrics — Tianjin, Tianjin Municipality, China
• Obstetrics&Gynecology Hospital of Fudan University — Shanghai, Yangpu District, China
• Beijing Cancer Hospital — Beijing, China
• Chongqing University Cancer Hospital — Chongqing, China
• Weifang People's Hospital — Weifang, China
• National Cancer Institute IRCCS "G. Pascale" Foundation — Naples, Campania, Italy
• University Hospital of Bologna-IRCCS — Bologna, Emilia-Romagna, Italy
• Romagnolo Institute For the Study of Tumors "Dino Amadori" — Meldola (FC), Forlì-Cesena, Italy
• Cannizzaro Emergency Hospital — Catania, Italy
• Complex Structure Gynecology Oncology National Cancer Institute of Milan — Milan, Italy
• Operative Unit of Oncology — Ravenna, Italy
• Agostino Gemelli University Hospital Rome — Rome, Italy
• Campus Bio Medico University Hospital Foundation — Rome, Italy

Full record on ClinicalTrials.gov

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