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CRLX101 in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)

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ClinicalTrials.gov Identifier: NCT02187302
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
NewLink Genetics Corporation

Brief Summary:
This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare which treatment resulted in longer time before progression of the RCC. Patients will be treated and followed for progression of their disease on average for up to 6 months.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: CRLX101 Drug: Bevacizumab Drug: Standard of Care (Investigator Choice) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2 Study to Assess the Safety and Efficacy of CRLX101 in Combination With Bevacizumab in Patients With Metastatic Renal Cell Carcinoma (RCC) Versus Standard of Care (SOC) (Investigator's Choice)
Study Start Date : July 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: CRLX101 + bevacizumab

CRLX101 in combination with bevacizumab:

  • CRLX101 15 mg/m^2 IV on days 1 and 15 of a 28-day cycle;
  • bevacizumab 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
Drug: CRLX101
Drug: Bevacizumab
Other Name: Avastin

Active Comparator: Standard of Care
Standard of care treatment include one of the following agents to which the patient can have no prior exposure: sorafenib; everolimus; pazopanib; axitinib; bevacizumab; sunitinib, or other approved drug considered by the Medical Monitor to represent an acceptable standard of care therapy
Drug: Standard of Care (Investigator Choice)
Other Names:
  • sorafenib (Nexavar), sunitinib (Sutent), axitinib (Inlyta), pazopanib (Votrient), bevacizumab (Avastin),
  • everolimus (Afinitor), Other




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: at least 6 months ]
    To assess progression free survival (PFS) in patients with clear cell metastatic renal cell carcinoma (RCC) treated with CRLX101 in combination with bevacizumab (CRLX101+bevacizumab) vs. standard of care (SOC) per investigator's choice, as assessed by blinded independent radiological review (IRR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1


Secondary Outcome Measures :
  1. Overall Safety and tolerability (AEs, SAEs, Clinical Laboratory Parameters, Vital Signs, Concomitant Medications) [ Time Frame: at least 30 days post last dose of study drug ]

    AEs will be coded using MedDRA and graded according to CTCAE (v 4.03). The number and percentage of patients with any treatment-emergent AE (TEAE) will be summarized for each treatment group. The number of patients with TEAEs assessed by the Investigator as at least possibly related to treatment will be tabulated. The number of patients with any CTCAE grade ≥ 3 treatment-emergent AE will be tabulated. Serious AEs (SAEs) will also be tabulated.

    For Clinical Laboratory Parameters - Shift tables that present changes from baseline to worst on-study values relative to CTCAE grading will be produced.

    For Vital Signs - By-patient data listings of vital sign measurements will be presented.

    For Concomitant Medications - The use of concomitant medications will be included in by-patient data listings. A summary table of concomitant medications by WHO drug class will also be provided.


  2. Overall survival [ Time Frame: on average 12 months after discontinuation of study treatment ]
    To compare time to death between treatment groups of CRLX101 in combination with bevacizumab compared to SOC.

  3. Objective response rate [ Time Frame: at least 6 months ]
    Evaluate response rates comparing the investigational treatment of CRLX101 in combination with bevacizumab compared to SOC as assessed by blinded IRR as well as by the Investigator

  4. Duration of Response [ Time Frame: at least 6 months ]
    Evaluate time to response comparing the investigational treatment of CRLX101 in combination with bevacizumab compared to SOC as assessed by blinded IRR as well as by the Investigator

  5. PFS [ Time Frame: at least 6 months ]
    To assess PFS in patients with clear cell metastatic RCC treated with CRLX101+bevacizumab vs. SOC per investigator's choice, as assessed at the site level by the Investigator according to RECIST version 1.1

  6. PFS [ Time Frame: at least 6 months ]
    To assess PFS (as assessed at the site level by the Investigator and separately by blinded IRR) in clear cell RCC patients treated with CRLX101+bevacizumab compared to bevacizumab treatment alone



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have histologically confirmed renal cell carcinoma of any pathologic subtype.
  • Must have unresectable metastatic disease, and have tumor(s) present that is (are) evaluable by the RECIST, v1.1; may have spinal-associated metastases but must have concluded dexamethasone therapy and be evaluated by the Investigator to have stable CNS disease.
  • Must have received 2 or 3 prior lines of conventional molecularly targeted therapy
  • Must have full recovery from any toxicities from prior therapy CTCAE Grade 1 or less with the exception of Grade 2 alopecia) prior to randomization.
  • ECOG performance status 0 or 1.
  • Age 18 years and older.
  • Life expectancy of at least 3 months.
  • Must have normal organ and marrow function reported within 14 days prior to randomization
  • Ability to understand and willingness to sign a written informed consent document.
  • Able to comply with study visit schedule and assessments.

Exclusion Criteria:

  • Any conventional molecularly targeted therapy within 2 weeks or, chemotherapy or radiotherapy within 2 weeks (local) or 4 weeks (systemic) prior to entering the study.
  • Failure to recover to grade 1 or less all prior adverse events.
  • Any major surgery within 4 weeks of study randomization.
  • Any prior treatment with topoisomerase I therapy.
  • Prior treatment with any drugs or therapies that will be administered during the course of this trial including CRLX101, any topoisomerase 1 inhibitor, bevacizumab or the conventional molecularly targeted agent intended for use as standard of care treatment.
  • Patients receiving any other current investigational therapeutic agent.
  • Other active malignancies
  • Patients with brain metastasis treated or untreated, or other CNS disease
  • Any clinically significant cardiac disease defined as NYHA class III or IV.
  • Uncontrolled hypertension
  • Uncontrolled concurrent illness
  • History of non-healing wounds or ulcers.
  • Pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding
  • Patients with known HIV or with solid organ transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187302


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Sponsors and Collaborators
NewLink Genetics Corporation
Investigators
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Study Chair: NewLink Genetics NewLink Genetics Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT02187302     History of Changes
Other Study ID Numbers: CRLX101-208
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by NewLink Genetics Corporation:
nanopharmaceutical,

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bevacizumab
Sunitinib
Everolimus
Sorafenib
Axitinib
Camptothecin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action