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) (AL3818)

November 7, 2023 updated by: Advenchen Laboratories, LLC

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

294

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Beijing Cancer Hospital
      • Chongqing, China
        • Chongqing University Cancer Hospital
      • Weifang, China
        • WeiFang People's Hospital
    • Henan
      • Hefei, Henan, China
        • Henan Cancer Hospital
    • Jilin
      • Changchun, Jilin, China
        • Jilin Cancer Hospital
    • Shenyang
      • Shenyang, Shenyang, China, 110001
        • The First Hospital of China Medical University
    • Sichuan
      • Chongqing, Sichuan, China
        • Zhongda Hospital Southeast University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Central Hospital of Gynecology obstetrics
    • Yangpu District
      • Shanghai, Yangpu District, China
        • Obstetrics&Gynecology Hospital of Fudan University
  • Italy
      • Catania, Italy
        • Cannizzaro Emergency Hospital
      • Milan, Italy
        • Complex Structure Gynecology Oncology National Cancer Institute of Milan
      • Ravenna, Italy, 44266
        • Operative Unit of Oncology
      • Rome, Italy
        • Agostino Gemelli University Hospital Rome
      • Rome, Italy
        • Campus Bio Medico University Hospital Foundation
    • Campania
      • Naples, Campania, Italy
        • National Cancer Institute IRCCS "G. Pascale" Foundation
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy
        • University Hospital of Bologna-IRCCS
    • Forlì-Cesena
      • Meldola (FC), Forlì-Cesena, Italy, 47014
        • Romagnolo Institute For the Study of Tumors "Dino Amadori"
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 05351
        • Samsung Medical Center
      • Seoul,, Korea, Republic of
        • Severance Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Clinic De Barcelona
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Murcia, Spain, 30120
        • HCU Virgen Arrixaca
    • Andalucía
      • Córdoba, Andalucía, Spain
        • Hospital Universitario Reina Sofia
      • Malaga, Andalucía, Spain, 29011
        • Hospital Regional Universitario de Malaga
    • Catalunya
      • Badalona, Catalunya, Spain, 08916
        • ICO Badalona
      • Barcelona, Catalunya, Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Hospital Clinico Universitario de Valencia
  • United Kingdom
      • London, United Kingdom
        • The Royal Marsden NHS Foundation Trust
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom
        • Cambridge University Hospitals NHS Foundation Trust
  • United States
    • California
      • Long Beach, California, United States, 90805
        • The Oncology Institute of Hope and Innovation
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington Oncology Research
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • AHN West Penn Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • UTSW
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Critera

  1. Female ≥ 18 years of age

  2. Histologically proven diagnosis of:

    a. 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

    b. 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.

    Phase III/Part 3:

(1) 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.

c. 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:

  1. Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets ≥ 100,000/mm3
  2. 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.
  3. Hepatic function: bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN for subjects with Gilbert Syndrome; AST and ALT ≤ 3.0 × ULN.
  4. Coagulation profile: international normalized ratio (INR) is ≤ 1.5 and an aPTT or PTT < 1.2 x ULN

  5. 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.

Exclusion Criteria

  1. Serious, non-healing wound, ulcer or bone fracture.
  2. 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).
  3. (Intentionally left blank)
  4. Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.

  5. 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.

  6. 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.
  7. 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.
  8. Women who are pregnant or nursing.
  9. (Intentionally left blank)
  10. Clinically significant, uncontrolled hypokalemia, hypomagnesaemia, and/or hypocalcaemia.
  11. Hemoptysis within 3 months prior to enrollment.
  12. Acute or chronic liver disease, active hepatitis A or B with known cirrhosis or liver dysfunction.
  13. Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 28 days (42 days in cases of mitomycin C, nitrosourea, lomustine) prior to enrollment.
  14. 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.
  15. Known history of human immunodeficiency virus infection (HIV).
  16. Active bacterial infections requiring systemic antibiotics (excluding uncomplicated urinary tract infection).
  17. 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.
  18. 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.
  19. History of significant vascular disease (e.g. aortic aneurysm, aortic dissection).
  20. Intra-abdominal abscess within the last 3 months of enrollment.
  21. 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.
  22. QTc > 470 msec on screening ECG per Fridericia's formula.
  23. History of or existing risk factors for Torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
  24. Concurrent use of concomitant medications that prolong the QT/QTc interval.
  25. Baseline echocardiogram (within 56 days of enrollment) with left ventricular ejection fraction (LVEF) < 50%.
  26. 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.
  27. History of pancreatitis; history of renal disease that includes histologically confirmed glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy or other renal insufficiencies.
  28. Treatment with an investigational agent within 28 days of enrollment.
  29. Known recreational substance abuse.
  30. 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.
  31. Known hypersensitivity to AL3818 or components of the formulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 3 -Active Treatment Arm

Phase 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
Drug: AL3818
Taken daily from Day 8 to Day 21 (14 days),administered orally combination with one background chemotherapy in 21-day cycles.
Other Names:
  • Anlotinib
  • Anlotinib Hydrochloride
  • Catequentinib
Drug: Paclitaxel

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

Drug: Pegylated Liposomal Doxorubicin (PLD)

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

Drug: 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
Other Names:
  • Daily Topotecan
Drug: Topotecan
Weekly Topotecan with a 1 week break every 3 weeks Suggested dose: 4 mg/m2 intravenously or local standard
Other Names:
  • Weekly Topotecan
Drug: Paclitaxel
175mg/m2 IV over 3 hours on Day 1 of each 21-Day cycle
Other Names:
  • Taxol
Drug: AL3818
Taken daily from Day 8 to Day 21 (14 days). Administered orally.
Other: Phase 3-Control Treatment Arm

Control 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
Drug: Paclitaxel

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

Drug: Pegylated Liposomal Doxorubicin (PLD)

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

Drug: 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
Other Names:
  • Daily Topotecan
Drug: Topotecan
Weekly Topotecan with a 1 week break every 3 weeks Suggested dose: 4 mg/m2 intravenously or local standard
Other Names:
  • Weekly Topotecan
Drug: Paclitaxel
175mg/m2 IV over 3 hours on Day 1 of each 21-Day cycle
Other Names:
  • Taxol
Experimental: Phase 1b: AL3818 plus carboplatin and paclitaxel
Phase 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.
Drug: AL3818
Taken daily from Day 8 to Day 21 (14 days),administered orally combination with one background chemotherapy in 21-day cycles.
Other Names:
  • Anlotinib
  • Anlotinib Hydrochloride
  • Catequentinib
Drug: Paclitaxel

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

Drug: Paclitaxel
175mg/m2 IV over 3 hours on Day 1 of each 21-Day cycle
Other Names:
  • Taxol
Drug: AL3818
Taken daily from Day 8 to Day 21 (14 days). Administered orally.
Drug: Carboplatin
AUC 5/6 on Day 1 of each 21-Day cycles
Other Names:
  • Paraplatin
Experimental: Phase 2a: AL3818 plus carboplatin and paclitaxel
Phase 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.
Drug: AL3818
Taken daily from Day 8 to Day 21 (14 days),administered orally combination with one background chemotherapy in 21-day cycles.
Other Names:
  • Anlotinib
  • Anlotinib Hydrochloride
  • Catequentinib
Drug: Paclitaxel

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

Drug: Paclitaxel
175mg/m2 IV over 3 hours on Day 1 of each 21-Day cycle
Other Names:
  • Taxol
Drug: AL3818
Taken daily from Day 8 to Day 21 (14 days). Administered orally.
Drug: Carboplatin
AUC 5/6 on Day 1 of each 21-Day cycles
Other Names:
  • Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b)
Time Frame: Cycle 1 (21-days)
Determine the Recommended Phase 2 Dose (RP2D) via evaluation of dose limiting toxicity (DLT) events.
Cycle 1 (21-days)
Objective Response Rates (ORR) - Part 2 (Phase 2a)
Time Frame: 12 months
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)
12 months
Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3)
Time Frame: 12 Months
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).
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Cycle 1 (Day 21)
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).
Cycle 1 (Day 21)
Clinical Benefit Rate (CBR) - Part 2 (Phase 2a)
Time Frame: 12 Months
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).
12 Months
Progression-Free Survival (PFS) - Part 2 (Phase 2a)
Time Frame: Duration of time from the start of treatment to the time of documented disease progression or death, whichever comes first, followed for 12 months.
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
Duration of time from the start of treatment to the time of documented disease progression or death, whichever comes first, followed for 12 months.
Overall Survival (OS) - Part 2 (Phase 2a)
Time Frame: Cycle 1 Day 1 up to 5 years
Overall survival is defined as the date the study treatment was initiated to the date of death from any cause. Kaplan-Meier analysis
Cycle 1 Day 1 up to 5 years
Objective Response Rate- Part 3 ( Phase 3)
Time Frame: 12 Months
To evaluate the efficacy between the Active Arm and Control Arm as measured by the secondary endpoints of objective response rate (ORR). (OS).
12 Months
Duration Of Response - Part 3 ( Phase 3)
Time Frame: 12 Months
To evaluate the efficacy between the Active Arm and Control Arm as measured by the secondary endpoints of duration of response (DOR)
12 Months
Overall Survival - Part 3 ( Phase 3)
Time Frame: 12 Months
To evaluate the efficacy between the Active Arm and Control Arm as measured by the endpoints of Overall survival
12 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity as assessed by CTCAE (v4.3) - Part 2 (Phase 2a)
Time Frame: 12 Months
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)
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advenchen Laboratories, LLC

Investigators

  • Study Director: Clinical Director, Advenchen Laboratories, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimated)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL3818-US-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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