Trial of CRLX101, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

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Brief Title

Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in People With Relapsed/Refractory Small Cell Lung Cancer

Official Title

A Phase I/II Trial of EP0057, a Nanoparticle Camptothecin With Olaparib in Patients With Relapsed/Refractory Small Cell Lung, Bladder and Prostate Cancers

Brief Summary

      Background: EP0057 consists of a sugar molecule cyclodextrin linked to a chemotherapy drug
      called camptothecin. The combined molecule or "nanoparticle drug conjugate" travels through
      the blood. Once inside cancer cells, the chemotherapy drug is released from the molecule.
      Olaparib is a drug that may stop cancer cells from repairing the DNA damage caused by
      chemotherapy. Researchers want to see how safe it is to give EP0057 and olaparib together and
      to see how well the combination treats a specific type of lung cancer called small cell lung
      cancer (SCLC).

      Objectives:

      To test the safety and maximum dose of EP0057 and olaparib together. To test how well they
      treat small cell lung cancer.

      Eligibility:

      Adults 18 and older with small cell lung cancer.

      Design:

      Participants will be screened with standard cancer care tests.

      Participants will get the 2 study drugs in 28-day cycles. EP0057 will be given every 2 weeks,
      through a small plastic tube in an arm vein. Olaparib will be taken by mouth twice a day most
      days. Participants will keep a pill diary.

      For Cycle 1, participants will have 3 visits. All other cycles will have 2 visits.

      At study visits, participants may have:

        -  Blood and hair samples taken

        -  History and Physical exam

        -  Questions about health and side effects

        -  Pregnancy test

        -  Optional tumor biopsy where a piece of tumor is removed by needle after numbing the
           skin.

        -  CT scan

        -  Injection of EP0057 (twice per cycle)

        -  Olaparib prescription 

      Participants will have a follow-up visit 4 weeks after finish taking the drugs. They will
      have a physical exam and blood tests. They may have a tumor biopsy. The study team will call
      the patient every 3 months for follow up after completing the study treatment.

      ...
    

Detailed Description

      Background:

      Small cell lung cancer (SCLC) is an aggressive cancer with a poor prognosis.

      Although highly responsive to chemotherapy initially, SCLC relapses quickly and becomes
      refractory to treatment within a few months.

      Urothelial Carcinoma (UC) of the Bladder is the fourth most common malignancy in men and the
      ninth most common in women.

      Prostate cancer is the most common cancer among men in the United States. While prostate
      cancer is initially responsive to androgen deprivation therapy (ADT), the median duration of
      sensitivity is 24-36 months. Moreover, patients develop resistance to current treatment
      options.

      The use of PARP inhibitors in combination with chemotherapy builds upon pre-clinical data in
      lung cancer and other cancers supporting the notion that PARP inhibitors potentiate the
      effect of DNA damaging therapies.

      Despite their highly synergistic activity in preclinical models, human studies combining PARP
      inhibitors and camptothecins have not translated into clinical benefit due to enhanced
      toxicity with the combination.

      One approach to improve ability to combine camptothecins with agents that sensitize their
      activity like PARP inhibitors is to use alternative formulations that minimize toxicity to
      the normal tissues.

      EP0057 is a nanoparticle drug conjugate composed of 20 (S)-camptothecin (a potent and highly
      selective topoisomerase I inhibitor) conjugated to a linear, cyclodextrin-polyethylene
      glycol-based polymer.

      Olaparib is a PARP inhibitor indicated as monotherapy in patients with deleterious or
      suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated
      with three or more prior lines of chemotherapy. Olaparib has an established safety profile
      and it is under investigation in a number of different cancers.

      Objectives:

      Phase I: To determine the MTD/recommended Phase 2 dose (RP2D) of EP0057 in combination with
      olaparib in patients with refractory cancers.

      Phase II: To determine the antitumor activity of olaparib plus EP0057 with respect to
      progression free survival at 16 weeks in SCLC patients with resistant or sensitive relapse.

      Expansion Cohorts: To determine overall response rate of EP0057 plus olaparib in patients
      with mCRPC and urothelial carcinoma.

      Eligibility:

      Phase I

      Male or female adult patients >=18 years of age

      Histologically or cytologically confirmed, advanced solid tumor that is refractory to
      standard therapy and/or for whom no further standard therapy is available

      ECOG Performance Status of 0, 1 or 2

      Phase II

      Male or female patients (Bullet) 18 years old

      Have a pathologically (histology or cytology) confirmed diagnosis of SCLC

      Disease progression on or after at least one platinum-based standard chemotherapy regimen
      and/or an immune-checkpoint inhibitor for either limited or extensive stage disease.

      Have measurable disease per RECIST 1.1

      ECOG performance status of 0, 1 or 2

      Phase II Expansion Cohorts

      Have a pathologically (histology or cytology) confirmed diagnosis of urothelial carcinoma or
      metastatic, progressive, castrate resistant prostate cancer (mCRPC)

      Disease progression on or after at least one platinum-based standard chemotherapy regimen
      and/or an immune-checkpoint inhibitor (except prostate cohort)

      Have measurable disease per RECIST 1.1 (except prostate cohort)

      Prior treatment with enzalutamide and/or abiraterone (prostate cancer cohort only)

      Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]) (Prostate cohort
      only)

      Design:

      Patients meeting eligibility criteria will receive EP0057 (IV Q 2weeks) plus olaparib (PO BID
      days 3-13 and days 17-26 administered in 28-day cycles, until disease progression or
      development of intolerable side effects. The MTD of the combination will be used in Phase II.

      Patients in Phase II will receive, the RP2D at DL4R EP0057 12 mg/m^2 and olaparib 250 mg BID.

      Blood, tumor and hair samples will be collected at multiple time points for PK, PD analyses.
      Hair sample collection is optional. Tumor biopsies are optional for SCLC and UC patients and
      mandatory for mCRPC patients (only baseline biopsy is mandatory).

      Toxicity will be graded according to CTCAE version 4.0.

      Tumor assessments will be made using CT scans (chest, abdomen and pelvis) at baseline and
      after every 2 cycles (3 cycles for mCRPC) according to RECIST version 1.1.

      After discontinuation of study treatment, follow-up for survival will be carried out every 3
      months.

      The maximum number of patients on the phase I portion of the trial is 30, the SCLC cohort in
      phase II may accrue up to 27 evaluable patients, urothelial carcinoma expansion cohort may
      accrue up to 34 patients and mCRPC may accrue up to 25 patients. Thus, the maximum number of
      evaluable patients who may enroll on this trial is 116. In order to allow for a small number
      of in-evaluable patients, the accrual ceiling will be set at 123.

      It is anticipated that approximately 1 to 2 patients per month may enroll onto this trial;
      the trial is expected to complete accrual in 6-8 years.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Expansion: To determine overall response rate of EP0057 plus olaparib in patients with mCRPC

Secondary Outcome

 To determine safety in patients on expansion cohorts: table of toxicities including type, severity, time of onset, time of resolution and probable association with study regimen

Condition

Urothelial Carcinoma

Intervention

EP0057

Study Arms / Comparison Groups

 1/Phase I
Description:  EP0057 + olaparib

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

123

Start Date

May 9, 2016

Completion Date

December 31, 2027

Primary Completion Date

July 1, 2023

Eligibility Criteria

        -  INCLUSION CRITERIA:

        Phase I:

          -  Patients must have advanced solid tumor that is resistant or refractory to standard
             therapy.

          -  A minimum of 2 weeks will be required from any prior therapy, including chemotherapy,
             immunotherapy and/or radiation. In addition, recovery to Grade less than or equal to 1
             from all reversible toxicities related to prior therapy is required at study entry.

          -  Patients do not need to have measurable disease to enroll on phase I.

          -  Age greater than or equal 18 years.

          -  ECOG performance status less than or equal to 2.

          -  Patients with treated brain metastases (surgery, whole or stereotactic brain
             radiation) are allowed provided the lesions have been stable for at least 2 weeks and
             the patient is off steroids or is on a stable dose of steroids. Patients with brain
             metastases should not require use of enzyme-inducing antiepileptic drugs (e.g.,
             carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and
             during study. Use of newer antiepileptics that do not produce enzyme induction
             drug-drug interactions (DDIs) is allowed.

          -  Patients must have normal organ and marrow function as defined below:

               -  leukocytes greater than or equal to 3,000/mcL

               -  absolute neutrophil count >1,500/mcL without growth factor support

               -  platelets greater than or equal 100,000/mcL without growth factor support

               -  hemoglobin greater than or equal 9 g/dL and no blood transfusion within 4 weeks
                  OR greater than 10 g/dL and no blood transfusion within 2 weeks.

               -  total bilirubin less than or equal 1.5 x ULN (unless Gilbert s Disease)

               -  AST(SGOT)/ALT(SGPT) less than or equal 2.5 X institutional upper limit of normal
                  (less than or wqual to 5X ULN if liver mets)

               -  creatinine less than ULN OR

               -  creatinine clearance greater than or equal 51 mL/min (calculated using the
                  Cockroft- Gault formula) for patients with creatinine levels above institutional
                  normal.

          -  The effects of EP0057 and olaparib on the developing human fetus are unknown. For this
             reason and because these agents as well as other therapeutic agents used in this trial
             are known to be teratogenic, women of child-bearing potential and men must agree to
             use adequate contraception (hormonal or barrier method of birth control; abstinence)
             prior to study entry, for the duration of study participation and for 120 days (both
             male and female) following last dose of study drug. Should a woman become pregnant or
             suspect she is pregnant while she or her partner is participating in this study, she
             should inform her treating physician immediately. Fertile females of childbearing
             potential are defined as women physically capable of becoming pregnant unless the
             female patient cannot have children because of surgery or other medical reasons
             (effective tubal ligation, ovaries or the uterus removed, or are post-menopausal).
             Post-menopausal is defined as:

               -  Amenorrheic for 1 year or more following cessation of exogenous hormonal
                  treatments,

               -  LH and FSH levels in the post menopausal range for women under 50,

               -  radiation-induced oophorectomy with last menses >1 year ago,

               -  chemotherapy-induced menopause with >1 year interval since last menses,

               -  or surgical sterilization (bilateral oophorectomy or hysterectomy).

          -  Negative urine pregnancy test less than or equal to 3 days prior to C1D1 (women of
             childbearing potential only)

          -  Patient is willing and able to comply with the protocol for the duration of the study
             including undergoing treatment and scheduled visits and examinations including follow
             up.

        Inclusion Criteria Phase II - SCLC:

          -  Age greater than or equal to18 years.

          -  Patients must have histologically or cytologically confirmed diagnosis of SCLC from a
             CLIA-certified laboratory.

          -  Have received and progressed during or after a platinum-based standard chemotherapy
             regimen and/or an immune-checkpoint inhibitor.

          -  Patients could have received any number of therapies for relapsed or progressive
             disease, including re-treatment with original frontline regimen. A minimum of 2 weeks
             will be required from any prior therapy, including chemotherapy, immunotherapy and/or
             radiation. In addition, recovery to Grade less than or equal to 1 from all reversible
             toxicities related to prior therapy is required at study entry. No previous
             irradiation to the site of measurable or evaluable disease, unless that site had
             subsequent evidence of progression.

          -  Patients must have measurable disease as per Response Evaluation Criteria in Solid
             Tumors, version (RECIST 1.1).

          -  Radiographic evidence of disease progression after initial therapy should have been
             documented.

          -  ECOG performance status less than or equal to 2.

          -  Patients with treated brain metastases (surgery, whole or stereotactic brain
             radiation) are allowed provided the lesions have been stable for at least 2 weeks and
             the patient is off steroids or is on a stable dose of steroids. Patients with brain
             metastases should not require use of enzyme-inducing antiepileptic drugs (e.g.,
             carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and
             during study. Use of newer antiepileptics that do not produce enzyme induction
             drug-drug interactions (DDIs) is allowed.

          -  Patients must have normal organ and marrow function as defined below:

               -  leukocytes greater than or equal to 3,000/mcL

               -  absolute neutrophil count greater than or equal to 1,500/mcL without growth
                  factor support

               -  platelets greater than or equal to 100,000/mcL without growth factor support

               -  hemoglobin greater than or equal to 9 g/dL and no blood transfusion within 4
                  weeks OR greater than 10 g/dL and no blood transusion within 2 weeks

               -  total bilirubin less than or equal to 1.5 x ULN (unless Gilbert s Disease)

               -  AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of
                  normal (less than or equal to 5X ULN if liver mets)

               -  creatinine less than ULN OR

               -  creatinine clearance greater than or equal to 51 mL/min (calculated using the
                  Cockroft- Gault formula) for patients with creatinine levels above institutional
                  normal.

          -  The effects of EP0057 and olaparib on the developing human fetus are unknown. For this
             reason and because these agents are known to be teratogenic, women of childbearing
             potential and men must agree to use highly effective contraception (hormonal or
             barrier method of birth control; abstinence) prior to study entry, for the duration of
             study participation and for 120 days (both male and female) following last dose of
             study drug. Should a woman become pregnant or suspect she is pregnant while she or her
             partner is participating in this study, she should inform her treating physician
             immediately. Fertile females of childbearing potential are defined as women physically
             capable of becoming pregnant unless the female patient cannot have children because of
             surgery or other medical reasons (effective tubal ligation, ovaries or the uterus
             removed, or are post-menopausal). Post-menopausal is defined as:

               -  Amenorrheic for 1 year or more following cessation of exogenous hormonal
                  treatments,

               -  LH and FSH levels in the post menopausal range for women under 50,

               -  radiation-induced oophorectomy with last menses >1 year ago,

               -  chemotherapy-induced menopause with >1 year interval since last menses,

               -  or surgical sterilization (bilateral oophorectomy or hysterectomy).

        INCLUSION CRITERIA FOR UROTHELIAL CARCINOMA EXPANSION COHORT:

          -  Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the
             bladder, urethra, ureter, or renal pelvis from a CLIA-certified laboratory, with
             measurable disease by RECIST including lymphadenopathy and visceral metastatic
             disease.

          -  Male or female patients greater than or equal to 18 years of age.

          -  Patient must have received at least one platinum based regimen of chemotherapy and/or
             an immune-checkpoint inhibitor if appropriate with progressive disease.

          -  Prior antiangiogenic therapy are permitted (2-week washout from therapy is required).

          -  Bisphosphonates and denosumab are permitted if on a stable dose for greater than equal
             to 4 weeks.

          -  ECOG 0-2

          -  Patients must have normal organ and marrow function as defined below:

          -  leukocytes greater than or equal to 3,000/mcL

          -  absolute neutrophil count greater than or equal to 1,500/mcL without growth factor
             support

          -  platelets greater than or equal to 100,000/mcL without growth factor support

          -  hemoglobin greater than or equal to 9 g/dL and no blood transfusion within 4 weeks OR
             hemoglobin >10 g/dL, and no blood transfusion within 2 weeks

          -  total bilirubin less than or equal to 1.5 x ULN (less than or equal to 3 (SqrRoot) ULN
             for subjects with Gilbert s Disease)

          -  AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
             (less than or equal to 5X ULN if liver mets)

          -  creatinine less than or equal to ULN OR

          -  creatinine clearance greater than or equal to 51 mL/min (calculated using the
             Cockroft-Gault formula) for patients with creatinine levels above institutional
             normal.

          -  PT/INR and aPTT within 1.25 X ULN institutional limits, except where a lupus
             anti-coagulant has been confirmed

          -  The effects of EP0057 and olaparib on the developing human fetus are unknown. For this
             reason and because these agents are known to be teratogenic, women of childbearing
             potential and men must agree to use highly effective contraception (hormonal or
             barrier method of birth control; abstinence) prior to study entry, for the duration of
             study participation and for 120 days (both male and female) following last dose of
             study drug. Should a woman become pregnant or suspect she is pregnant while she or her
             partner is participating in this study, she should inform her treating physician
             immediately. Fertile females of childbearing potential are defined as women physically
             capable of becoming pregnant unless the female patient cannot have children because of
             surgery or other medical reasons (effective tubal ligation, ovaries or the uterus
             removed, or are post-menopausal). Post-menopausal is defined as:

               -  Amenorrheic for 1 year or more following cessation of exogenous hormonal
                  treatments,

               -  LH and FSH levels in the post menopausal range for women under 50,

               -  radiation-induced oophorectomy with last menses >1 year ago,

               -  chemotherapy-induced menopause with >1 year interval since last menses,

               -  or surgical sterilization (bilateral oophorectomy or hysterectomy).

          -  Patients must be able to tolerate oral medications and not have gastrointestinal
             illnesses that would preclude absorption of olaparib.

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Willingness to release archival tissue sample for research purposes, if available

        INCLUSION CRITERIA FOR mCRPC EXPANSION COHORT (accrual to the mCRPC cohort ended with
        amendment version 7/27/2021)

          -  Patients must have metastatic, progressive, castrate resistant prostate cancer
             (mCRPC).

          -  Documented histopathological confirmation of prostate cancer from a CLIA-certified
             laboratory.

          -  All patients must have at least one lesion deemed safe to biopsy and be willing to
             undergo a mandatory baseline biopsy.

          -  Patients must have received prior treatment with enzalutamide and/or abiraterone with
             the exception of patients who were treated with docetaxel and androgen deprivation
             therapy for metastatic castrate-sensitive prostate cancer and progressed on docetaxel
             treatment or who progress within one month of the last docetaxel dose.

          -  Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l])

          -  Patients must have undergone bilateral surgical castration or must agree to continue
             on GnRH agonists/antagonists for the duration of the study.

          -  ECOG performance status less than or equal to 2

          -  Patients must have adequate bone marrow, hepatic, and renal function with:

          -  leukocytes greater than or equal to 3,000/mcL

          -  absolute neutrophil count greater than or equal to 1,500/mcL without growth factor
             support

          -  platelets greater than or equal to 100,000/mcL without growth factor support

          -  hemoglobin greater than or equal to 9 g/dL and no blood transfusion within 4 weeks OR
             hemoglobin > 10g/dL, and no blood transfusion within 2 weeks

          -  total bilirubin less than or equal to 1.5 x ULN (less than or equal to 3 (SqrRoot) ULN
             for subjects with Gilbert s Disease)

          -  AST(SGOT)/ALT(SGPT) <3 X institutional upper limit of normal (less than or equal to 5X
             ULN if liver mets)

          -  creatinine less than or equal to ULN OR

          -  creatinine clearance greater than or equal to 51 mL/min (calculated using the
             Cockroft-Gault formula) for patients with creatinine levels above institutional
             normal.

               -  Men must be at least 18 years of age.

               -  Patient must be capable of understanding and complying with protocol requirements
                  and is willing to give informed consent.

          -  Men treated or enrolled on this protocol must also agree to use adequate contraception
             prior to the study and for the duration of study participation and for 120 days after
             last dose of study drug. Sexually active subjects and their female partners must agree
             to use medically accepted barrier methods of contraception (e.g., male or female
             condom) during the course of the study and for 3 months after the last dose of study
             drug(s), even if oral contraceptives are also used. All subjects of reproductive
             potential must also agree to use both a barrier method and a second method of birth
             control during the course of the study and for 3 months after the last dose of study
             drug(s). Should a woman become pregnant or suspect she is pregnant while her partner
             is pa...
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anish Thomas, M.D., (240) 760-6117, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02769962

Organization ID

160107

Secondary IDs

16-C-0107

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Anish Thomas, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

September 14, 2021