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Endometrial CarcinomaPhase 3AL3818NCT02584478

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)

A Phase 3 study testing AL3818, Paclitaxel and Pegylated Liposomal Doxorubicin (PLD) in people with Endometrial Carcinoma and Ovarian Carcinoma, run by Advenchen Laboratories, LLC at 41 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
AL3818, Paclitaxel and Pegylated Liposomal Doxorubicin (PLD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
294 participants
Where
41 sitesin 6 countries
Study dates
Dec 2015to Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female ≥ 18 years of age
  • Histologically proven diagnosis of:
  • Endometrial and other uterine cancers with tumors of all histologies i. Recurrent Stage I to II endometrial and other uterine cancers, after at least one prior line of standard therapy, requiring further treatment with platinum-based chemotherapy ii. Advanced Stage III to IV endometrial and other uterine cancers requiring treatment with platinum-based chemotherapy
  • Ovarian Cancer: Platinum-sensitive or platinum-resistant recurrent or metastatic ovarian, fallopian, or primary peritoneal cancer treated with at least one prior line of platinum-based chemotherapy and requiring further treatment.(Part 1/Phase Ib, Part 2/Phase 2a)
  • Platinum-sensitive is defined as cancer progression ≥ 6 months after platinum- based chemotherapy. Platinum-resistant is defined as cancer progression < 6 months after platinum-based chemotherapy.
  • Histologic cell types eligible are endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified.
Show all 21Show fewer
  • Phase III/Part 3:
  • Platinum-resistant (progression within 6 months after last platinum-based chemotherapy) ovarian, fallopian, or primary peritoneal cancer that meets one of the following criteria: i. Subject has received at least two prior lines of systemic therapy including a bevacizumab-containing regimen as standard of care ii. Subject has received at least two prior lines of systemic therapy, has not received a prior bevacizumab-containing regimen and is not eligible for a bevacizumab containing regimen based on Investigator's assessment (2) Platinum-refractory (progression during first-line platinum-based chemotherapy) ovarian, fallopian, or primary peritoneal cancer after at least one prior line of systemic therapy (3) For groups 1-2 above: Subjects with positive deleterious or suspected deleterious, germline or somatic BRCA mutated status must have received a PARP inhibitor as a prior line of therapy.
  • Cervical cancer: recurrent or metastatic cervical cancer that is not amenable to curative treatment with surgery and/or radiation therapy after at least one prior line of standard therapy, requiring further treatment. Histologic cell types eligible are squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma
  • 3. Have measureable disease defined by RECIST 1.1 confirmed by CT or MRI scan within 28 days of enrollment.
  • 4. Life expectancy of ≥ 3 months at the time of enrollment.
  • 5. Able to take orally administered study medication.
  • 6. Have adequate baseline function and performance status within 28 days of enrollment:
  • Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3
  • Renal function: creatinine ≤ 1.5 x institutional upper limit normal (ULN) or if creatinine is > 1.5 x ULN, creatinine clearance must be > 50 mL/min.
  • Hepatic function: bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN for subjects with Gilbert Syndrome; AST and ALT ≤ 3.0 × ULN.
  • Coagulation profile: international normalized ratio (INR) is ≤ 1.5 and an aPTT or PTT < 1.2 x ULN
  • ECOG performance ≤ 2
  • 7. Women of child-bearing potential must agree to use contraceptive measures starting 1 week before C1D1 until 4 weeks after the last dose of study treatment and have a negative serum pregnancy test within 28 days of enrollment.
  • 8. Provide written informed consent and authorization permitting release of Protected Health Information.
  • 9. Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.

Who cannot join

  • 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).
  • (Intentionally left blank)
  • 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.
  • 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.
Show all 32Show fewer
  • 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.
  • (Intentionally left blank)
  • 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.
  • Baseline echocardiogram (within 56 days of enrollment) with left ventricular ejection fraction (LVEF) < 50%.
  • History of difficulty swallowing, malabsorption, active partial or complete bowel obstruction, or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption of AL3818.
  • History of pancreatitis; history of renal disease that includes histologically confirmed glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy or other renal insufficiencies.
  • Treatment with an investigational agent within 28 days of enrollment.
  • Known recreational substance abuse.
  • Anticoagulation therapy with warfarin. Subjects treated with heparin, low molecular weight heparin, or any other anticoagulant may be included provided the subject has been on a stable therapeutic dose of the anticoagulant for at least 14 days prior to enrollment.
  • Known hypersensitivity to AL3818 or components of the formulation.

Trial locations and contacts

41 sites in 6 countries.

41 sites in 6 countries

China9 sites

  • Beijing Cancer Hospital

    Beijing

  • Jilin Cancer Hospital

    Changchun, Jilin

  • Zhongda Hospital Southeast University

    Chongqing, Sichuan

  • Chongqing University Cancer Hospital

    Chongqing

  • Henan Cancer Hospital

    Hefei, Henan

  • Obstetrics&Gynecology Hospital of Fudan University

    Shanghai, Yangpu District

  • The First Hospital of China Medical University

    Shenyang, Shenyang, 110001

  • Tianjin Central Hospital of Gynecology Obstetrics

    Tianjin, Tianjin Municipality

  • Weifang People's Hospital

    Weifang

Other trials in China

Spain9 sites

  • ICO Badalona

    Badalona, Catalonia, 08916

  • Hospital Universitari Vall d'Hebrón

    Barcelona, Catalonia, 08035

  • Hospital Clínic de Barcelona

    Barcelona

  • Hospital Universitario Reina Sofía

    Córdoba, Andalusia

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Regional Universitario de Málaga

    Málaga, Andalusia, 29011

  • HCU Virgen Arrixaca

    Murcia, 30120

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia

Other trials in Spain

United States8 sites

  • UTSW

    Dallas, Texas, 75390

  • Baptist Health Lexington Oncology Research

    Lexington, Kentucky, 40503

  • The Oncology Institute of Hope and Innovation

    Long Beach, California, 90805

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • AHN West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Washington University

    St Louis, Missouri, 63130

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Italy8 sites

  • University Hospital of Bologna-IRCCS

    Bologna, Emilia-Romagna

  • Cannizzaro Emergency Hospital

    Catania

  • Romagnolo Institute For the Study of Tumors "Dino Amadori"

    Meldola (FC), Forlì-Cesena, 47014

  • Complex Structure Gynecology Oncology National Cancer Institute of Milan

    Milan

  • National Cancer Institute IRCCS "G. Pascale" Foundation

    Naples, Campania

  • Operative Unit of Oncology

    Ravenna, 44266

  • Agostino Gemelli University Hospital Rome

    Rome

  • Campus Bio Medico University Hospital Foundation

    Rome

Other trials in Italy

South Korea4 sites

  • Samsung Medical Center

    Seoul, 05351

  • Korea University Guro Hospital

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

Other trials in South Korea

United Kingdom3 sites

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire

  • The Royal Marsden NHS Foundation Trust

    London

  • The Christie NHS Foundation Trust

    Manchester

Other trials in United Kingdom

About this study

Official title: A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma

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.

Read the detailed description

This trial is a Phase 1b/2a/3 trial designed to evaluate the safety and efficacy of adding oral AL3818(Anlotinib, INN: Catequentinib) to standard platinum-based chemotherapy concurrently and continued as a maintenance therapy for up to 12 months, in subjects with recurrent or metastatic endometrial, ovarian, fallopian, primary peritoneal, or cervical carcinoma. AL3818 is a novel small molecule dual receptor tyrosine kinase inhibitor, which shows highly selective inhibition of fibroblast growth factor receptor (FGFr) and vascular endothelial growth factor receptor (VEGFR). Preclinical studies of this agent in mouse models, including various cancer xenografts, have demonstrated that treatment of tumor-bearing mice with AL3818 induces tumor reductions.

Phase 1 \& 2: This study is divided into two parts. The objective of Part 1 is the evaluation of the safety and tolerability of adding oral AL3818 to standard carboplatin plus paclitaxel chemotherapy for a cycle of 21 days to determine the recommended Phase II dose (RP2D). Phase 1 / Part 1 is now complete. Part 2-The objective of Part 2 is evaluation of preliminary efficacy and the safety of adding oral AL3818 at the RP2D determined in Part 1 to carboplatin and paclitaxel chemotherapy for 6 cycles. Continuous maintenance mono therapy with 14 days on and 7 days off regimen at the RP2D will be conducted up to 12 months and is extendable beyond until disease progression. Phase I is closed and Phase 2 is closed.

Phase 3: This study is currently a Phase III, multi-center, randomized trial with active control designed to evaluate the efficacy and safety of AL3818 8 mg plus background treatment (Active Arm) vs background treatment alone (Control Arm), where three background treatments, weekly paclitaxel, pegylated liposomal doxorubicin (PLD), and topotecan are utilized. Oral AL3818 8 mg may be given concurrently with background treatment or alone if the background treatment must be discontinued due to its toxicity for up to 24 cycles of therapy, in subjects with recurrent or metastatic platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Phase 3 is open.

Being tested
AL3818, Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), Topotecan, Carboplatin
Keywords
Dual receptor Tyrosine Kinase Inhibitor, Anti-angiogenic therapy, Combination Therapy
Medical subject headings
Endometrial Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AL3818Drug

    Also called Anlotinib Hydrochloride, Anlotinib, Catequentinib

    Taken daily from Day 8 to Day 21 (14 days),administered orally combination with one background chemotherapy in 21-day cycles.

  • PaclitaxelDrug

    Weekly single agent Paclitaxel will be administered on Day 1, 8, and 15 of each 21-day cycle. Suggested dose: 80 mg/m^2 intravenously or local standard.

    Paclitaxel may also be administered once weekly with a 1-week break every 3 weeks in lieu of every week

  • Pegylated Liposomal Doxorubicin (PLD)Drug

    Single agent Pegylated Liposomal Doxorubicin (PLD) administered every 4 weeks on the following cycle days corresponding with AL3818 cycles until maximum cumulative dose per local standard reached.

    Suggested dose: 40 mg/m^2 intravenously or local standard

  • TopotecanDrug

    Also called Daily Topotecan

    Daily Topotecan on Days 1-5 of each 21-day cycle Suggested dose: 1.25 mg/m2 intravenously or local standard OR Weekly Topotecan with a 1 week break every 3 weeks. Suggested dose: 4 mg/m2 intravenously or local standard

  • TopotecanDrug

    Also called Weekly Topotecan

    Weekly Topotecan with a 1 week break every 3 weeks Suggested dose: 4 mg/m2 intravenously or local standard

  • CarboplatinDrug

    Also called Paraplatin

    AUC 5/6 on Day 1 of each 21-Day cycles

  • PaclitaxelDrug

    Also called Taxol

    175mg/m2 IV over 3 hours on Day 1 of each 21-Day cycle

  • AL3818Drug

    Taken daily from Day 8 to Day 21 (14 days). Administered orally.

Study groups in NCT02584478
Study groupRoleWhat they receive
Phase 3 -Active Treatment ArmExperimentalPhase 3: AL3818 8 mg once daily in combination with one background chemotherapy in 21-day cycles. Platinum resistant recurrent or metastatic ovarian, fallopian, or primary peritoneal cancer subjects will be enrolled into one of the following three background chemotherapy groups: * Weekly paclitaxel (default choice; if the subject is ineligible for paclitaxel, the investigator will select from PLD or topotecan) * Pegylated liposomal doxorubicin (PLD) * Topotecan
Receives: Drug: AL3818; Drug: Paclitaxel; Drug: Pegylated Liposomal Doxorubicin (PLD); Drug: Topotecan
Phase 3-Control Treatment ArmOtherControl Treatment Arm: Background chemotherapy treatment alone. Platinum resistant recurrent or metastatic ovarian, fallopian, or primary peritoneal cancer subjects will be enrolled into one of the following three background chemotherapy groups: * Weekly paclitaxel (default choice; if the subject is ineligible for paclitaxel, the investigator will select from PLD or topotecan) * Pegylated liposomal doxorubicin (PLD) * Topotecan
Receives: Drug: Paclitaxel; Drug: Pegylated Liposomal Doxorubicin (PLD); Drug: Topotecan
Phase 1b: AL3818 plus carboplatin and paclitaxelExperimentalPhase 1b: Sequential deescalating dosing evaluation to determine the recommended Phase II dose (RP2D). For 21-day treatment cycles, cohort 1 (3 subjects) will be administered carboplatin (AUC 5/6 over 30 minutes) and paclitaxel (175mg/m2 over 3 hours) intravenously on Day 1. AL3818 is orally administered daily starting on Day 8 until Day 21 (14 days) at an initial dose of 12 mg/day.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: AL3818
Phase 2a: AL3818 plus carboplatin and paclitaxelExperimentalPhase 2a: subjects will receive chemotherapy and oral AL3818 for 6 cycles (18 weeks, 21-day cycles of treatment) followed by continuous maintenance treatment of oral AL3818 for up to 12 months. Subjects will be administered carboplatin (AUC 5/6 over 30 minutes) and paclitaxel (175mg/m2 over 3 hours) intravenously on Day 1. AL3818 is orally administered daily starting on Day 8 until Day 21 (14 days) at the RP2D found in Phase 1b.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: AL3818

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b)

    Determine the Recommended Phase 2 Dose (RP2D) via evaluation of dose limiting toxicity (DLT) events.

    Measured: Cycle 1 (21-days)

  2. Objective Response Rates (ORR) - Part 2 (Phase 2a)

    Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST, v1.1) criteria after three complete 21-day cycles in the first 9 cycles then once every 6 cycles for up to 12 months. ORR is measured by the number of complete (CR) and partial responses (PR)

    Measured: 12 months

  3. Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3)

    To evaluate the efficacy between the Active Arm (AL3818 in combination with background chemotherapy) and Control Arm (background chemotherapy alone arm) as measured by the primary endpoint of Progression Free Survival (PFS).

    Measured: 12 Months

Secondary outcomes (7)

  1. Number of Participants with Adverse Events as a measure of safety and toxicity of 21-Day cycles of AL3818 as measured by incidence and severity of treatment-related adverse events (TRAE) - Part 1 (Phase 1b)

    Incidence and severity of treatment-related adverse events reported and their relationship to AL3818 will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.3).

    Measured: Cycle 1 (Day 21)

  2. Clinical Benefit Rate (CBR) - Part 2 (Phase 2a)

    Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST, v1.1) criteria after three complete 21-day cycles in the first 9 cycles then once every 6 cycles for up to 12 months. Measured as CR+PR+SD (SD ≥ 16 weeks from inclusion).

    Measured: 12 Months

  3. Progression-Free Survival (PFS) - Part 2 (Phase 2a)

    Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST, v1.1) criteria after three complete 21-day cycles in the first 9 cycles then once every 6 cycles for up to 12 months. Kaplan-Meier analysis

    Measured: Duration of time from the start of treatment to the time of documented disease progression or death, whichever comes first, followed for 12 months.

  4. Overall Survival (OS) - Part 2 (Phase 2a)

    Overall survival is defined as the date the study treatment was initiated to the date of death from any cause. Kaplan-Meier analysis

    Measured: Cycle 1 Day 1 up to 5 years

  5. Objective Response Rate- Part 3 ( Phase 3)

    To evaluate the efficacy between the Active Arm and Control Arm as measured by the secondary endpoints of objective response rate (ORR). (OS).

    Measured: 12 Months

  6. Duration Of Response - Part 3 ( Phase 3)

    To evaluate the efficacy between the Active Arm and Control Arm as measured by the secondary endpoints of duration of response (DOR)

    Measured: 12 Months

  7. Overall Survival - Part 3 ( Phase 3)

    To evaluate the efficacy between the Active Arm and Control Arm as measured by the endpoints of Overall survival

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Overall duration of the study will be approximately 42 months. Part 1 and 2 of this study are not randomized and have no concurrent controls. AL3818 and chemotherapy will be administered in an open-label fashion. Phase III/Part 3 is unblinded and randomized. Within each one of the three background chemotherapy groups, subjects will be randomized at a 1:1 ratio stratified by prior angiogenesis inhibitors mainly Avastin use status (Yes or No) and number of prior treatment (≤3 or \>3) to receive AL3818 plus background chemotherapy (Active Arm) or background chemotherapy alone (Control Arm).
Masking
None (open label)
Enrolment
294 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02584478
Sponsor's protocol ID
AL3818-US-002
Acronym
AL3818
Status last verified
Nov 2023
First submitted
28 Aug 2015
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Hoeben A, Landuyt B, Highley MS, Wildiers H, Van Oosterom AT, De Bruijn EA. Vascular endothelial growth factor and angiogenesis. Pharmacol Rev. 2004 Dec;56(4):549-80. doi: 10.1124/pr.56.4.3.

    PubMed 15602010

  • Kondo Y, Arii S, Mori A, Furutani M, Chiba T, Imamura M. Enhancement of angiogenesis, tumor growth, and metastasis by transfection of vascular endothelial growth factor into LoVo human colon cancer cell line. Clin Cancer Res. 2000 Feb;6(2):622-30.

    PubMed 10690548

  • Roskoski R Jr. Vascular endothelial growth factor (VEGF) signaling in tumor progression. Crit Rev Oncol Hematol. 2007 Jun;62(3):179-213. doi: 10.1016/j.critrevonc.2007.01.006. Epub 2007 Feb 26.

    PubMed 17324579

  • Dickson C, Spencer-Dene B, Dillon C, Fantl V. Tyrosine kinase signalling in breast cancer: fibroblast growth factors and their receptors. Breast Cancer Res. 2000;2(3):191-6. doi: 10.1186/bcr53. Epub 2000 Mar 25.

    PubMed 11250709

  • Cole C, Lau S, Backen A, Clamp A, Rushton G, Dive C, Hodgkinson C, McVey R, Kitchener H, Jayson GC. Inhibition of FGFR2 and FGFR1 increases cisplatin sensitivity in ovarian cancer. Cancer Biol Ther. 2010 Sep 1;10(5):495-504. doi: 10.4161/cbt.10.5.12585. Epub 2010 Sep 4.

    PubMed 20595807

  • Raja FA, Griffin CL, Qian W, Hirte H, Parmar MK, Swart AM, Ledermann JA. Initial toxicity assessment of ICON6: a randomised trial of cediranib plus chemotherapy in platinum-sensitive relapsed ovarian cancer. Br J Cancer. 2011 Sep 27;105(7):884-9. doi: 10.1038/bjc.2011.334. Epub 2011 Aug 30.

    PubMed 21878941

  • Ledermann JA, Perren TJ, Raja FA, et al: Randomized double-blind phase III trial of cediranib (AZD 2171) in relapsed platinum-sensitive ovarian cancer: Results of the ICON6 trial. European Cancer Congress. Abstract 10. Presented September 30, 2013.

  • Niu G, Chen X. Vascular endothelial growth factor as an anti-angiogenic target for cancer therapy. Curr Drug Targets. 2010 Aug;11(8):1000-17. doi: 10.2174/138945010791591395.

    PubMed 20426765

  • Shen GH, Ghazizadeh M, Kawanami O, Shimizu H, Jin E, Araki T, Sugisaki Y. Prognostic significance of vascular endothelial growth factor expression in human ovarian carcinoma. Br J Cancer. 2000 Jul;83(2):196-203. doi: 10.1054/bjoc.2000.1228.

    PubMed 10901370

  • Chen CA, Cheng WF, Lee CN, Chen TM, Kung CC, Hsieh FJ, Hsieh CY. Serum vascular endothelial growth factor in epithelial ovarian neoplasms: correlation with patient survival. Gynecol Oncol. 1999 Aug;74(2):235-40. doi: 10.1006/gyno.1999.5418.

    PubMed 10419737

  • Yoneda J, Kuniyasu H, Crispens MA, Price JE, Bucana CD, Fidler IJ. Expression of angiogenesis-related genes and progression of human ovarian carcinomas in nude mice. J Natl Cancer Inst. 1998 Mar 18;90(6):447-54. doi: 10.1093/jnci/90.6.447.

    PubMed 9521169

  • Cannistra SA, Matulonis UA, Penson RT, Hambleton J, Dupont J, Mackey H, Douglas J, Burger RA, Armstrong D, Wenham R, McGuire W. Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer. J Clin Oncol. 2007 Nov 20;25(33):5180-6. doi: 10.1200/JCO.2007.12.0782.

    PubMed 18024865

  • Burger RA, Brady MF, Bookman MA et al. Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC) or fallopian tube cancer (FTC): A Gynecologic Oncology Group study. Journal of Clinical Oncology, 2010 ASCO Annual Meeting Proceedings. Vol. 28, No 18S, 2010 June 20 suppl: Abstract LBA1

  • Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, Husain A, Sovak MA, Yi J, Nycum LR. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012 Jun 10;30(17):2039-45. doi: 10.1200/JCO.2012.42.0505. Epub 2012 Apr 23.

    PubMed 22529265

  • Yokoyama Y, Charnock-Jones DS, Licence D, Yanaihara A, Hastings JM, Holland CM, Emoto M, Sakamoto A, Sakamoto T, Maruyama H, Sato S, Mizunuma H, Smith SK. Expression of vascular endothelial growth factor (VEGF)-D and its receptor, VEGF receptor 3, as a prognostic factor in endometrial carcinoma. Clin Cancer Res. 2003 Apr;9(4):1361-9.

    PubMed 12684405

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AL3818, Paclitaxel and Pegylated Liposomal Doxorubicin (PLD) in people with Endometrial Carcinoma and Ovarian Carcinoma, run by Advenchen Laboratories, LLC at 41 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in China, Spain, United States, Italy, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b) (time frame: Cycle 1 (21-days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02584478, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.

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