Phase 1/2a Evaluation of AL3818 in Subjects With Recurrent or Metastatic Endometrial, Ovarian or Cervical Cancer (AL3818-US-001)

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Brief Title

Phase 1/2a Evaluation of AL3818 in Subjects With Recurrent or Metastatic Endometrial, Ovarian or Cervical Cancer (AL3818-US-001)

Official Title

A Phase 1/2a Evaluation of the Safety, Pharmacokinetics and Efficacy of AL3818, a Dual Receptor Tyrosine Kinase Inhibitor, in Subjects With Recurrent or Metastatic Endometrial, Ovarian or Cervical Cancer (AL3818-US-001)

Brief Summary

      The purpose of Part 1 (Phase 1b) is to evaluate the general safety and tolerability of
      repeated 21-day cycles of AL3818 therapy, and to reevaluate the maximum tolerated dose (MTD).

      The purpose of Part 2 (Phase 2a) is to evaluate the efficacy of repeated 21-day cycles of
      AL3818 therapy preliminary efficacy of AL3818 in subjects with recurrent or metastatic
      endometrial, ovarian or cervical cancer.
    

Detailed Description

      This is a Phase 1b/2a study to evaluate the safety, pharmacokinetics and efficacy of 21-day
      cycles of AL3818 therapy. The study is divided into two parts. Part 1 (Phase 1b) will
      evaluate the dose limiting toxicity (DLT) and general safety during the first 21-day cycle of
      Al3818 therapy and to reevaluate the MTD. It will include a sequential evaluation of 3
      subjects per cohort in a 3+3 design with up to 18 subjects in total. Cohort 1 will initiate
      at a dose of 12 mg/day of AL3818, for cycles of 14 days of treatment followed by 7 days of
      rest. After three subjects have completed the first cycle of therapy without a DLT,
      additional cohorts may be enrolled sequentially. All subjects will be allowed continuation of
      therapy with repeat cycles of 21-days if they are tolerating AL3818 and have stable disease
      or better. After the first cohort has completed one full cycle of therapy without a DLT, two
      additional cohorts will be sequentially enrolled at 16 mg/day and 20 mg/day doses of AL3818
      for the same 21-day cycles.

      Part 2 (Phase 2a) will evaluate the safety and preliminary efficacy of repeated 21-day cycles
      of AL3818. It will include up to 45 additional subjects with metastatic endometrial cancer,
      ovarian cancer refractory to platinum therapy or cervical cancer refractory to standard
      therapy. Each subject will receive a dose of up to 20 mg AL3818 or a maximum of the MTD from
      Part 1 (Phase 1b) of this study for continuous 21-Day cycles of therapy (14 days of AL3818
      treatment followed by 7 days off).

      All subjects in Part 1 and Part 2 of this study will be permitted to continue therapy with
      only safety monitoring and bimonthly assessments for progression, if AL3818 is well tolerated
      and the subject has stable disease or better.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Pharmacokinetics (PK) of plasma AL3818 - Part 1 (Phase 1b)

Condition

Endometrial Cancer

Intervention

AL3818

Study Arms / Comparison Groups

 AL3818
Description:  Part 1 (Phase 1b): Cohort 1 will initiate at a dose of 12 mg/day of AL3818, for 21-Day cycles (14 days of AL3818 treatment followed by 7 days of rest). After three subjects have completed the first cycle of therapy without a DLT, additional cohorts may be enrolled sequentially. After the first cohort has completed one full cycle of therapy without a DLT, two additional cohorts will be sequentially enrolled at 16 mg/day and 20 mg/day doses of AL3818 for the same 21-day cycles.
Part 2 (Phase 2a): Each subject will receive a dose of up to 20 mg AL3818 or a maximum of the MTD from Part 1 (Phase 1b) of this study for continuous 21-Day cycles of therapy (14 days of AL3818 treatment followed by 7 days of rest).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

November 2015

Completion Date

May 30, 2017

Primary Completion Date

February 14, 2017

Eligibility Criteria

        Inclusion Criteria:

        For a subject to be eligible for this study, she must meet all of the following criteria:

          1. Female subjects 18 years of age or older

          2. Subjects may be enrolled with previous histologically proven diagnosis of the
             following:

             a. Endometrial Cancer: Patients must have recurrent or persistent endometrial
             carcinoma, which is refractory to curative therapy or established treatments.

             i. Histologic diagnosis will be reviewed by the treating institution ii. Patients with
             the following histologic epithelial cell types are eligible: Endometrioid
             adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell
             adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified,
             mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma.

             iii. Initial treatment may have included chemotherapy, chemotherapy and radiation
             therapy, and/or consolidation/maintenance therapy; antiangiogenic therapy (e.g.
             bevacizumab) as part of adjuvant therapy is allowed. Chemotherapy administered in
             conjunction with primary radiation as a radio-sensitizer will be counted as a systemic
             chemotherapy regimen.

             iv. Patients should have received no more than two prior cytotoxic or non-cytotoxic
             therapies for management of recurrent or persistent disease (excluding endocrine
             therapies which will not count in the number of regimens)

             b. Ovarian cancer: Patients must have recurrent or persistent ovarian, fallopian tube
             or primary peritoneal cancer, which is refractory to established treatments.

             i. Patients with the following histologic epithelial cell types are eligible:
             Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear
             cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise
             specified.

             ii. Patients must have received at least one prior platinum-based chemotherapeutic
             regimen for the management of primary disease containing carboplatin, cisplatin, or
             another organoplatinum compound.

             iii. This initial therapy may have included high-dose therapy, consolidation, or
             extended therapy administered after surgical or non-surgical assessment.

             iv. Antiangiogenic therapy (e.g. bevacizumab) as part of adjuvant therapy is allowed.

             v. Patients should have received no more than two prior cytotoxic or non-cytotoxic
             therapies for management of recurrent or persistent disease

             c. Cervix cancer: Subjects diagnosed with histologically confirmed squamous cell
             carcinoma of the cervix.

             i. Patients must have received at least one prior platinum based chemotherapeutic
             regimen for the management of primary disease containing carboplatin, cisplatin or
             another organoplatinum compound. The initial therapy may have included high-dose
             therapy, consolidation or extended therapy administered after surgical or non-surgical
             assessment. Antiangiogenic therapy (e.g. bevacizumab) as part of adjuvant therapy is
             allowed. Chemotherapy administered in conjunction with primary radiation as a
             radio-sensitizer will be counted as a systemic chemotherapy regimen.

             ii. Patients should have received no more than two prior cytotoxic or non-cytotoxic
             standard therapies for management of recurrent or persistent disease.

             d. Other uterine cancers: Subjects diagnosed with other uterine cancers, such as
             Leiomyosarcoma, and have received no more than two prior cytotoxic or non-cytotoxic
             standard therapies for management of recurrent or persistent disease.

          3. For Phase 2a only, all patients must express at least one FGFr 1, 2 or 3 amplification
             (or mutation) from archived tissue or new biopsy. For non-amplified patients, approval
             of the site coordinator or the sponsor is required prior to enrollment.

          4. All patients must have measurable disease. Measurable disease is defined as at least
             one lesion that can be accurately measured in at least one dimension (longest
             dimension to be recorded). Each lesion must be ≥ 20mm when measured by conventional
             techniques, including palpation, plain x-ray, CT, and MRI, or ≥ 10mm when measured by
             spiral CT.

          5. Life expectancy ≥ 3 months

          6. Subject must be suitable for oral administration of study medication

          7. Patients must have signed an approved informed consent and authorization permitting
             release of personal health information.

          8. Patient must have adequate:

               1. Bone Marrow Function: Absolute neutrophil count (ANC) greater then or equal to
                  1,500/mm3, equivalent to Common Toxicity Criteria (CTC) grade 1. Platelets
                  greater than or equal to 100,000/mm3

               2. Renal Function: Creatinine less than or equal to 1.5 x institutional upper limit
                  normal (ULN), CTC grade 1. Note: If creatinine is greater than 1.5 x ULN,
                  creatinine clearance must be greater than >50 mL/min.

               3. Hepatic Function: Bilirubin less than or equal to 1.5 x ULN (CTC grade 1) or less
                  than or equal to 3.0 x ULN for subjects with Gilbert Syndrome; AST and ALT less
                  than or equal to 3.0 ×ULN.

               4. Coagulation profile: PT such that international normalized ratio (INR) is ≤ 1.55
                  (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of
                  therapeutic warfarin or low molecular weight heparin) and a PTT < 1.2 times
                  control.

          9. ECOG performance status ≤ 2.

         10. Subjects of child-bearing potential must agree to use contraceptive measures starting
             1 week before the administration of the first dose of AL3818 until 4 weeks after
             discontinuing study drug.

         11. Subjects of child-bearing potential must have a negative serum pregnancy test prior to
             study entry and cannot be lactating.

         12. Ability and willingness to comply with the study protocol for the duration of the
             study and with follow-up procedures.

        Exclusion Criteria

        Subjects who meet any of the following criteria will be excluded from participation in the
        study:

          1. Subjects who have received prior treatment with an FGFr inhibitor or antagonist of
             FGFr. Prior anti-VEGF or anti-angiogenic therapy is allowed in the adjuvant treatment
             setting Prior anti-VEGF or anti-angiogenic therapy for the treatment of recurrent
             disease is not allowed.

          2. Patients who have received prior antiangiogenic therapy, including bevacizumab,
             sorafenib, sunitinib, in the setting of advanced disease.

          3. Patients with serious, non-healing wound, ulcer or bone fracture.

          4. Patients with active bleeding or pathologic conditions that carry high risk of
             bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major
             vessels.

          5. Patient 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 6 months of the first date of treatment
             on this study.

          6. However, patients with metastatic CNS tumors may participate in this trial, if the
             patient is > 4 weeks from therapy completion (including radiation and/or surgery), is
             clinically stable at the time of study entry and is not receiving corticosteroid
             therapy.

          7. Patients with proteinuria. Patients discovered to have a urine protein of 1+ on
             dipstick or ≥ 30 mg/dl at baseline should undergo a 24-hour urine collection, which
             must be an adequate collection and must demonstrate < 1000 mg protein/24 hr to allow
             participation in the study.

          8. Patients with clinically significant cardiovascular disease; this includes:
             Uncontrolled hypertension; Myocardial infarction or unstable angina within 6 months
             prior to registration; New York Heart Association (NYHA) Grade II or greater
             congestive heart failure (Appendix F); Serious cardiac arrhythmia requiring
             medication; Grade II or greater peripheral vascular disease (Appendix F).

          9. Patients who are pregnant or nursing. To date, no fetal studies of AL3818 in animals
             or humans have been performed. Therefore, AL3818 should not be administered to
             pregnant women. Subjects will be apprised of the large potential risk to a developing
             fetus. It is not known whether AL3818 is excreted in human milk. Because many drugs
             are excreted in human milk, AL3818 should not be administered to nursing women. Women
             of childbearing potential must agree to use contraceptive measures during study
             therapy and for at least 3 months after completion of AL3818 therapy. Because many
             drugs are excreted in human milk.

         10. Patients with uncontrolled hypokalemia, hypomagnesaemia, and/or hypocalcaemia.

         11. Hemoptysis within 3 months prior to first scheduled dose of AL3818.

         12. Patients with acute or chronic liver disease, active hepatitis A or B with known
             cirrhosis or liver dysfunction.

         13. Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks in
             cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of AL3818
             or a major surgical procedure within 28 days or minor surgical procedure performed
             within 7 days prior to first scheduled dose of AL3818.

         14. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19
             who cannot be switched to other alternative medications (See Appendix E).

         15. Known history of human immunodeficiency virus infection (HIV).

         16. Subjects with active bacterial infections (other than uncomplicated urinary tract
             infection) and/or receiving systemic antibiotics.

         17. Patients with 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
             or whose previous cancer treatment contraindicates this protocol therapy.

         18. History of non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer
             disease within the past 3-months that in the opinion of the investigator may place the
             patient 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.

         21. History of uncontrolled hypertension that is not well managed by medication, as
             documented by 2 baseline evaluations taken one hour apart with systolic blood pressure
             >160 mm or diastolic blood pressure >90 mm Hg pressure, or that in the opinion of the
             investigator may place the patient at risk when taking a VEGF inhibitor.

         22. Pre-existing uncontrolled hypertension as documented by 2 baseline BP readings taken
             at least one hour apart, defined as systolic bloodpressure (BP) >160 mm Hg or
             diastolic BP > 90 mm Hg pressure.

         23. QTcF>470 msec on screening ECG.

         24. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family
             history of Long QT Syndrome).

         25. The use of concomitant medications that prolong the QT/QTc interval.

         26. Baseline echocardiogram (within 2 months) with left ventricular ejection fraction
             (LVEF) < 50%.

         27. 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.

         28. History of pancreatitis and/or renal disease that includes histologically confirmed
             glomerulonephritis, biopsy proven tubulointerstitial nephritis, crystal nephropathy,
             or other renal insufficiencies.

         29. Treatment with an investigational agent within the longest time frame of either 5
             half- lives or 30 days of initiating study drug.

         30. Known recreational substance abuse.

         31. Known hypersensitivity to anti-angiogenic agents.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Clinical Director, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02558348

Organization ID

AL3818-US-001


Responsible Party

Sponsor

Study Sponsor

Advenchen Laboratories, LLC


Study Sponsor

Clinical Director, Study Director, Advenchen Laboratories, LLC


Verification Date

June 2019