Obinutuzumab in Combination With Ibrutinib in Treating Patients With Relapsed Mantle Cell Lymphoma

Sponsor
OHSU Knight Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02736617
Collaborator
Genentech, Inc. (Industry), Oregon Health and Science University (Other)
10
Enrollment
1
Location
1
Arm
58.9
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial studies how well obinutuzumab works in combination with ibrutinib in treating patients with mantle cell lymphoma that has returned (relapsed) or that does not respond to treatment (refractory). Obinutuzumab binds to a protein called cluster of differentiation (CD)20, which is found on B cells and some types of leukemia and lymphoma cells and help the immune system kill cancer cells. Ibrutinib blocks a protein called Bruton's tyrosine kinase (BTK), which may help keep cancer cells from growing. Giving obinutuzumab in combination with ibrutinib may kill more cancer cells.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. Best overall response of complete response/partial response (CR/PR).
SECONDARY OBJECTIVES:
  1. Toxicity defined as any adverse event (AE) grade 3 and higher. II. Progression free survival.
EXPLORATORY/CORRELATIVE OBJECTIVES:
  1. Gene expression profiling using Lymph5Cx test. II. Sequencing using the ion torrent platform (76 gene panel for known mutations in lymphoma).

  2. Sequencing of BTK and phospholipase-C gamma (PLC) to evaluate for mutations.

  3. Minimal residual disease testing (MRD by flow cytometry and targeted sequencing post treatment).

OUTLINE:

Patients receive obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving partial response (PR) continue to receive obinutuzumab IV every 2 months and ibrutinib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for up to 3 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Obinutuzumab (GA-101) in Combination With Ibrutinib (I) for the Treatment of Relapsed Mantle Cell Lymphoma
Actual Study Start Date :
Jul 5, 2016
Actual Primary Completion Date :
Jun 2, 2021
Actual Study Completion Date :
Jun 2, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treatment (obinutuzumab and ibrutinib)

Patients receive obinutuzumab IV over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib PO QD on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have PR continue to receive obinutuzumab IV every 2 months and ibrutinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.

Drug: Ibrutinib
Given PO
Other Names:
  • BTK Inhibitor PCI-32765
  • CRA-032765
  • Imbruvica
  • PCI-32765
  • Biological: Obinutuzumab
    Given IV
    Other Names:
  • Anti-CD20 Monoclonal Antibody R7159
  • GA-101
  • GA101
  • Gazyva
  • huMAB(CD20)
  • R7159
  • RO 5072759
  • RO-5072759
  • RO5072759
  • Outcome Measures

    Primary Outcome Measures

    1. Percent of Participants With Best Overall Objective Response or Complete Response/Partial Response (CR/PR) [From first dose of study therapy until the 6-month disease assessment (Cycle 6, Day1 or End of Induction Day 28). Disease assessment is also assessed at end of Cycle 2 (2-months).]

      Overall response is measured combining bone marrow biopsy with CT or PET, measuring target and evaluable non-targeted lesions, according to the Lugano criteria. For FDG-PET, the Deauville criteria is used in conjecture with CT to assess lesion FDG-update. Deauville scale ranges from 1 to 5, where 1 is best (no uptake or no residual uptake) and 5 is worst (markedly increased uptake or any new lesion). If bone marrow is involved prior to treatment, infiltrate must have cleared on repeat biopsy for CR; bone marrow assessment is irrelevant for determination of PR. Measurements are taken at baseline, end of cycle 2, end of induction (after cycle 6) and every 4 months thereafter. Best overall response is any CR or PR reported since start of therapy. Percent of participants with complete response or partial response (CR+PR) are reported along with 95% confidence interval.

    Secondary Outcome Measures

    1. Progression Free Survival (PFS) [Time from the first day of combined study treatment to disease progression or death, whichever occurs first, assessed up to approximately 4 years, 11 months, after first dose of study drug(s)]

      Median progression free survival is measured from first day of study therapy until disease progression or death, whichever comes first. Participants who progress prior to their first scheduled disease assessment are considered to have clinically progressed. Participants who do not progress are censored at the time of their last disease assessment. The Kaplan-Meier method is used to estimate median PFS. 95% confidence interval is provided, although upper limit was not achieved (insufficient number of progressions)

    2. Number of Participants With Treatment-related Toxicities, Grade 3 or Higher, as Assessed by CTCAE v4.0 [Measured from the first dose of either study drug until 30 days after the last dose of study drug, for approximately 4 years, 11 months.]

      Defined as any adverse event grade 3 or higher, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, from the first dose of study drug(s) until 30 days after the last dose of study drug(s)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects must have a diagnosis of relapsed or refractory mantle cell lymphoma as follows:

    • Diagnosis of mantle cell lymphoma (MCL) must include morphology and expression of either cyclin D1 in association with other relevant markers (eg, CD19, CD20, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)

    • Relapsed or refractory disease is defined as no response or progressive disease to prior treatment if the prior treatment comprised any of the following:

    • 1 regimen containing an anti-CD20 antibody administered for >= 2 doses, and/or

    • = 1 regimen containing 1 cytotoxic agent (e.g., bendamustine, chlorambucil, cyclophosphamide, cytarabine, doxorubicin) administered for 2 cycles

    • At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma (Cheson Criteria); the site of disease must be greater than 1.5 cm in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions

    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

    • Absolute neutrophil count (ANC) >= 1.0 K/cu mm; for subjects with ANC < 1.0 K/cu mm due to significant marrow involvement by MCL, ANC must be > .5 K/cu mm

    • Platelets (plt) >= 50 K/cu mm; for subjects with plt < 50 K/cu mm due to significant marrow involvement by MCL, plt must be > 25 K/cu mm

    • Total bilirubin =< 2.5 X institutional limits

    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal

    • Creatinine =< 2

    • Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during and after the study; for females, these restrictions apply for 18 months after last dose of obinutuzumab, or 1 month after the last dose of ibrutinib, whichever is later; for males, these restrictions apply for 180 days after the last dose of obinutuzumab or 3 months after the last dose of ibrutinib, whichever is later

    • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study

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

    Exclusion Criteria:
    • Major surgery within 4 weeks of drug administration

    • Diagnosed or treated for malignancy other than MCL, except:

    • Malignancy treated with curative intent and with no known active disease present for >= 2 years

    • Adequately treated non-melanoma skin cancer or melanoma in situ without evidence of disease

    • Adequately treated cervical carcinoma in situ without evidence of disease

    • Asymptomatic prostate cancer managed with "active surveillance"

    • Localized prostate cancer treated with definitive treatment including radiation or surgery. Patients on adjuvant hormone deprivation treatment such as lupron are eligible. Patients with known metastatic disease are ineligible

    • History of stroke or intracranial hemorrhage within 6 months prior to randomization

    • Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)

    • Vaccinated with live, attenuated vaccines within 4 weeks of randomization

    • Requires treatment with strong cytochrome P450 3A (CYP3A) inhibitors

    • Subjects who have had standard cytotoxic chemotherapy or radiotherapy within 3 weeks prior to entering the study or those whose adverse events due to agents administered more than 3 weeks earlier have not recovered to =< grade 1; this excludes alopecia and hematologic adverse events

    • Subjects who have had radiotherapy within 2 weeks prior to entering the study or those whose adverse events due to radiotherapy more than 2 weeks earlier have not recovered to =< grade 1

    • Subjects who have received investigational or approved oral or "targeted" agents (such as spleen tyrosine kinase [SYK], phosphatidylinositol 3 kinase [PI3K], B-cell chronic lymphocytic leukemia [CLL]/lymphoma 2 [bcl-2], BTK inhibitors) or lenalidomide within 1 week prior to entering the study or those whose adverse events due to agents administered more than 1 week earlier have not recovered to =< grade 1; this excludes hematologic adverse events; the exception is subjects who are currently receiving ibrutinib (for < 14 days). In this case, ibrutinib can be continued

    • Subjects who have received monoclonal antibodies (such as Rituxan) within 1 week prior to entering the study or those whose adverse events due to agents administered more than 1 week earlier have not recovered to =< grade 1; this excludes hematologic adverse events

    • Subjects who are actively receiving any other investigational agents

    • History of severe allergic reactions attributed to compounds of similar chemical or biologic composition as obinutuzumab or ibrutinib or other agents used in the study

    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

    • Pregnant or lactating women are excluded from this study

    • Known history of human immunodeficiency virus (HIV) or active hepatitis C

    • Virus or active hepatitis B virus infection; patients who are hepatitis B core antibody (HBcAb) positive may be eligible as long as there is no evidence of active infection with negative hepatitis B (Hep B) by polymerase chain reaction (PCR); in this case, Hep B PCR must be monitored monthly

    • Any uncontrolled active systemic infection requiring intravenous (IV) antibiotics

    • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk

    • Patients previously treated with ibrutinib > 14 days are ineligible; no drug intervention or cessation is required for patients already receiving ibrutinib prior to initiation of on-study therapy

    • Active graft versus (vs.) host disease (GVHD)

    • Ongoing glucocorticoids (prednisone > 10 mg daily, or equivalent); higher doses (> 10 mg daily) are permitted for up to 5 days to help control disease related symptoms

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1OHSU Knight Cancer InstitutePortlandOregonUnited States97239

    Sponsors and Collaborators

    • OHSU Knight Cancer Institute
    • Genentech, Inc.
    • Oregon Health and Science University

    Investigators

    • Principal Investigator: Stephen E Spurgeon, OHSU Knight Cancer Institute

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephen Spurgeon, Principal Investigator, OHSU Knight Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT02736617
    Other Study ID Numbers:
    • STUDY00015255
    • NCI-2016-00398
    • STUDY00015255
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleOverall Study
    Arm/Group DescriptionParticipants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
    Period Title: Treatment
    STARTED10
    COMPLETED7
    NOT COMPLETED3
    Period Title: Treatment
    STARTED7
    COMPLETED2
    NOT COMPLETED5

    Baseline Characteristics

    Arm/Group TitleOverall Study
    Arm/Group DescriptionParticipants who receive at least one dose of either study drug.
    Overall Participants10
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    72.0
    Sex: Female, Male (Count of Participants)
    Female
    1
    10%
    Male
    9
    90%
    Race/Ethnicity, Customized (Count of Participants)
    White, non-Hispanic
    10
    100%
    Disease status at enrollment (Count of Participants)
    Stable Disease
    5
    50%
    Progressive Disease
    5
    50%
    Mantle Cell Lymphoma International Prognositic Index (MIPI) Risk Class (Count of Participants)
    Intermediate Risk
    3
    30%
    High Risk
    7
    70%
    Ki-67 positivity, % (proliferation marker) (percent positive nuclei in field) [Median (Full Range) ]
    Median (Full Range) [percent positive nuclei in field]
    65
    Eastern Cooperative Oncology Group (ECOG) at screening (Count of Participants)
    ECOG 0
    1
    10%
    ECOG 1
    9
    90%
    Months between diagnosis and enrollment (Months) [Median (Full Range) ]
    Median (Full Range) [Months]
    21.5

    Outcome Measures

    1. Primary Outcome
    TitlePercent of Participants With Best Overall Objective Response or Complete Response/Partial Response (CR/PR)
    DescriptionOverall response is measured combining bone marrow biopsy with CT or PET, measuring target and evaluable non-targeted lesions, according to the Lugano criteria. For FDG-PET, the Deauville criteria is used in conjecture with CT to assess lesion FDG-update. Deauville scale ranges from 1 to 5, where 1 is best (no uptake or no residual uptake) and 5 is worst (markedly increased uptake or any new lesion). If bone marrow is involved prior to treatment, infiltrate must have cleared on repeat biopsy for CR; bone marrow assessment is irrelevant for determination of PR. Measurements are taken at baseline, end of cycle 2, end of induction (after cycle 6) and every 4 months thereafter. Best overall response is any CR or PR reported since start of therapy. Percent of participants with complete response or partial response (CR+PR) are reported along with 95% confidence interval.
    Time FrameFrom first dose of study therapy until the 6-month disease assessment (Cycle 6, Day1 or End of Induction Day 28). Disease assessment is also assessed at end of Cycle 2 (2-months).

    Outcome Measure Data

    Analysis Population Description
    Efficacy evaluable population: those who receive at least one dose of both study drugs and had one response assessment (after cycle 2). Any patient who clinically progresses prior to their first scheduled response assessment will be included in the efficacy set and will be counted as a non-responder.
    Arm/Group TitleEfficacy Evaluable
    Arm/Group DescriptionParticipants who receive at least one dose of both study drugs and have one response assessment (after cycle 2) are eligible for the efficacy evaluable set. Participants progressing prior to the first scheduled response assessment are counted as non-responders. Evaluable participants who do not have response assessments (e.g. are removed for toxicity) are also counted as non-responders. All other progressions must be confirmed by imaging. One participant withdrew consent 6 days after starting study therapy and was considered ineligible for the efficacy evaluable set.
    Measure Participants9
    Number (95% Confidence Interval) [percentage of participants]
    89
    890%
    2. Secondary Outcome
    TitleProgression Free Survival (PFS)
    DescriptionMedian progression free survival is measured from first day of study therapy until disease progression or death, whichever comes first. Participants who progress prior to their first scheduled disease assessment are considered to have clinically progressed. Participants who do not progress are censored at the time of their last disease assessment. The Kaplan-Meier method is used to estimate median PFS. 95% confidence interval is provided, although upper limit was not achieved (insufficient number of progressions)
    Time FrameTime from the first day of combined study treatment to disease progression or death, whichever occurs first, assessed up to approximately 4 years, 11 months, after first dose of study drug(s)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEfficacy Evaluable
    Arm/Group DescriptionParticipants who receive at least one dose of both study drugs and have one response assessment (after cycle 2) are eligible for the efficacy evaluable set. Participants progressing prior to the first scheduled response assessment are counted as non-responders. Evaluable participants who do not have response assessments (e.g. are removed for toxicity) are also counted as non-responders. All other progressions must be confirmed by imaging. One participant withdrew consent 6 days after starting study therapy and was considered ineligible for the efficacy evaluable set.
    Measure Participants9
    Median (95% Confidence Interval) [months]
    14
    3. Secondary Outcome
    TitleNumber of Participants With Treatment-related Toxicities, Grade 3 or Higher, as Assessed by CTCAE v4.0
    DescriptionDefined as any adverse event grade 3 or higher, classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0, from the first dose of study drug(s) until 30 days after the last dose of study drug(s)
    Time FrameMeasured from the first dose of either study drug until 30 days after the last dose of study drug, for approximately 4 years, 11 months.

    Outcome Measure Data

    Analysis Population Description
    All participants receiving at least 1 dose of IV Obinutuzumab or oral Ibrutinib
    Arm/Group TitleOverall Study
    Arm/Group DescriptionParticipants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
    Measure Participants10
    Infections and infestations
    1
    10%
    Infusion related reaction
    1
    10%
    Neutrophil count decreased
    4
    40%
    Platelet count decreased
    2
    20%
    Stroke
    1
    10%

    Adverse Events

    Time FrameFrom the first dose of either IV Obinutuzumab or oral Ibrutinib until 30 days after the last dose, up to approximately 5 years (4 years, 11 months)
    Adverse Event Reporting Description All AE and SAE were collected and reporting, irrespective of grade or attribution. Given only 10 participants were enrolled we were unable to apply the 5% threshold on adverse events.
    Arm/Group TitleOverall Study
    Arm/Group DescriptionParticipants receive 1000mg Obinutuzumab intravenously (IV) over 30 minutes on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6. Patients also receive ibrutinib once daily by mouth on days 1-28. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have at least partial response (PR) will continue to receive obinutuzumab IV every 2 months and oral ibrutinib for 2 years in the absence of disease progression or unacceptable toxicity.
    All Cause Mortality
    Overall Study
    Affected / at Risk (%)# Events
    Total0/10 (0%)
    Serious Adverse Events
    Overall Study
    Affected / at Risk (%)# Events
    Total4/10 (40%)
    Infections and infestations
    Infections and infestations - Other, specify2/10 (20%) 2
    Injury, poisoning and procedural complications
    Infusion related reaction1/10 (10%) 1
    Musculoskeletal and connective tissue disorders
    Pain in extremity1/10 (10%) 1
    Nervous system disorders
    Somnolence1/10 (10%) 1
    Stroke1/10 (10%) 1
    Other (Not Including Serious) Adverse Events
    Overall Study
    Affected / at Risk (%)# Events
    Total9/10 (90%)
    Cardiac disorders
    Atrial fibrillation1/10 (10%) 1
    Cardiac disorders - Other, specify2/10 (20%) 3
    Palpitations1/10 (10%) 1
    Supraventricular tachycardia1/10 (10%) 1
    Ear and labyrinth disorders
    Hearing impaired1/10 (10%) 1
    Eye disorders
    Eye disorders - Other, specify2/10 (20%) 3
    Gastrointestinal disorders
    Diarrhea3/10 (30%) 3
    Gastritis1/10 (10%) 1
    Gastrointestinal disorders - Other, specify3/10 (30%) 6
    Hemorrhoids1/10 (10%) 1
    Nausea4/10 (40%) 4
    Oral hemorrhage1/10 (10%) 1
    Vomiting1/10 (10%) 1
    General disorders
    Edema limbs1/10 (10%) 1
    Fatigue3/10 (30%) 7
    Fever1/10 (10%) 1
    Pain2/10 (20%) 2
    Infections and infestations
    Infections and infestations - Other, specify1/10 (10%) 1
    Otitis media1/10 (10%) 1
    Sinusitis2/10 (20%) 5
    Tooth infection1/10 (10%) 1
    Upper respiratory infection4/10 (40%) 4
    Wound infection1/10 (10%) 1
    Injury, poisoning and procedural complications
    Bruising4/10 (40%) 5
    Fall1/10 (10%) 1
    Infusion related reaction3/10 (30%) 3
    Injury, poisoning and procedural complications - Other, specify1/10 (10%) 1
    Wound dehiscence1/10 (10%) 1
    Investigations
    Blood bilirubin increased2/10 (20%) 2
    Neutrophil count decreased4/10 (40%) 15
    Platelet count decreased4/10 (40%) 8
    Weight gain1/10 (10%) 1
    Weight loss1/10 (10%) 1
    Metabolism and nutrition disorders
    Anorexia3/10 (30%) 4
    Musculoskeletal and connective tissue disorders
    Arthralgia3/10 (30%) 5
    Bone pain3/10 (30%) 3
    Chest wall pain1/10 (10%) 1
    Generalized muscle weakness1/10 (10%) 2
    Musculoskeletal and connective tissue disorder - Other, specify1/10 (10%) 2
    Myalgia2/10 (20%) 2
    Pain in extremity3/10 (30%) 4
    Nervous system disorders
    Dizziness1/10 (10%) 2
    Headache1/10 (10%) 1
    Nervous system disorders - Other, specify4/10 (40%) 7
    Neuralgia1/10 (10%) 1
    Psychiatric disorders
    Anxiety1/10 (10%) 1
    Confusion1/10 (10%) 1
    Depression1/10 (10%) 1
    Renal and urinary disorders
    Renal and urinary disorders - Other, specify1/10 (10%) 1
    Urinary incontinence1/10 (10%) 1
    Respiratory, thoracic and mediastinal disorders
    Allergic rhinitis1/10 (10%) 1
    Cough1/10 (10%) 1
    Dyspnea2/10 (20%) 3
    Epistaxis1/10 (10%) 3
    Productive cough2/10 (20%) 2
    Skin and subcutaneous tissue disorders
    Alopecia1/10 (10%) 1
    Nail loss1/10 (10%) 1
    Pruritus1/10 (10%) 1
    Rash acneiform1/10 (10%) 1
    Rash maculo-papular1/10 (10%) 1
    Skin and subcutaneous tissue disorders - Other, specify5/10 (50%) 7
    Vascular disorders
    Hypertension4/10 (40%) 4

    Limitations/Caveats

    Study was powered to detect an 85% response rate compared to a 55% control rate. Simon's Two-Stage design planned to enroll 6 at Stage 1; if 4 or more achieved CR/PR then an additional 14 would be enrolled in Stage 2 for a total of 20 participants. Study satisfied Stage 1 requirements but lagging enrollment caused study to close with only 10 participants enrolled. Of the 10 only 9 were efficacy evaluable. Power: P(x>=8|n=9, p=0.85) = 0.599; x=success, n=evaluable, p=expected probability

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Stephen E. Spurgeon, Associate Professor of Medicine
    OrganizationOregon Health and Sciences University, Knight Cancer Institute
    Phone503-494-8950
    Emailspurgeos@ohsu.edu
    Responsible Party:
    Stephen Spurgeon, Principal Investigator, OHSU Knight Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT02736617
    Other Study ID Numbers:
    • STUDY00015255
    • NCI-2016-00398
    • STUDY00015255
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Dec 1, 2021