- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498613
A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors
Study Overview
Status
Conditions
- Metastatic Lung Non-Small Cell Carcinoma
- Pancreatic Ductal Adenocarcinoma
- Advanced Malignant Solid Neoplasm
- Unresectable Pancreatic Carcinoma
- Metastatic Pancreatic Adenocarcinoma
- Stage III Pancreatic Cancer AJCC v6 and v7
- Stage IV Pancreatic Cancer AJCC v6 and v7
- Stage IIIA Lung Non-Small Cell Cancer AJCC v7
- Triple-Negative Breast Carcinoma
- Metastatic Triple-Negative Breast Carcinoma
- Stage IV Breast Cancer AJCC v6 and v7
- Stage III Breast Cancer AJCC v7
- Stage IIIA Breast Cancer AJCC v7
- Stage IIIB Breast Cancer AJCC v7
- Stage IIIC Breast Cancer AJCC v7
- Unresectable Pancreatic Adenocarcinoma
- Metastatic Lung Small Cell Carcinoma
- Stage IIIB Lung Non-Small Cell Cancer AJCC v7
- Stage IV Lung Non-Small Cell Cancer AJCC v7
- Stage III Lung Non-Small Cell Cancer AJCC v7
- Unresectable Lung Small Cell Carcinoma
- Unresectable Triple-Negative Breast Carcinoma
- Stage III Lung Small Cell Carcinoma AJCC v7
- Stage IIIA Lung Small Cell Carcinoma AJCC v7
- Stage IIIB Lung Small Cell Carcinoma AJCC v7
- Stage IV Lung Small Cell Carcinoma AJCC v7
Detailed Description
PRIMARY OBJECTIVE:
I. To determine the objective response rate (ORR) of cediranib (cediranib maleate) plus olaparib in combination in patients with advanced or metastatic solid tumors of the following tumor types: non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic ductal adenocarcinoma (PDAC), and small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of oral administration of cediranib in combination with olaparib in patients with select advanced solid tumors.
II. To estimate progression free survival (PFS) in each tumor cohort.
EXPLORATORY OBJECTIVES:
I. To estimate the prevalence of the mutations of deoxyribonucleic acid (DNA) repair genes in tumors using the BROCA panel and to correlate tumor regression with mutations status. (Integrated) II. To evaluate changes in tumor hypoxia on cediranib treatment compared to baseline by [F-18] fluoromisonidazole (FMISO) positron emission tomography/computed tomography (PET/CT) in patients with NSCLC.
III. To evaluate levels of angiogenesis/inflammatory markers including VEGF at baseline and on treatment.
IV. To evaluate levels of circulating tumor deoxyribonucleic acid (ctDNA) at baseline and on treatment.
OUTLINE:
Patients receive cediranib maleate orally (PO) once daily (QD) on day 1. Patients undergoing FMISO scan also receive olaparib PO twice daily (BID) beginning the day after the second FMISO scan and the rest of the patients receive olaparib PO BID beginning day 4 of cycle 1. Cycles repeat every 28 days (35 days for cycle 1) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks. Patients who discontinue the study treatment for reasons other than disease progression or withdrawal of consent will continue to be followed every 4 weeks until disease progression, start of new therapy, or death, whichever occurs first.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 4E6
- BCCA-Vancouver Cancer Centre
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- University Health Network-Princess Margaret Hospital
-
-
-
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California
-
La Jolla, California, United States, 92093
- UC San Diego Moores Cancer Center
-
Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
-
San Diego, California, United States, 92103
- UC San Diego Medical Center - Hillcrest
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San Francisco, California, United States, 94115
- UCSF Medical Center-Mount Zion
-
-
Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University
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New Haven, Connecticut, United States, 06510
- Smilow Cancer Center/Yale-New Haven Hospital
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-
Florida
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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Tampa, Florida, United States, 33607
- Moffitt Cancer Center-International Plaza
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
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Farmington Hills, Michigan, United States, 48334
- Weisberg Cancer Treatment Center
-
-
Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must have histologically confirmed, metastatic or unresectable malignancy of the following types: (a) non-small cell lung cancer (NSCLC), (b) triple-negative breast cancer (TNBC; defined by estrogen receptor [ER] < 1%, progesterone receptor [PR] < 1% and HER2 1+ or less by immunohistochemistry [IHC]; if HER-2 expression is 2+, a negative fluorescence in situ hybridization [FISH] testing is required) (c) pancreatic adenocarcinoma (PDAC), or (d) small cell lung cancer (SCLC)
- Must have received at least one line of standard systemic treatment for locally advanced or metastatic disease setting of the respective tumor type; for NSCLC, it is either PD-1/PD-L1 inhibitor, or platinum-containing chemotherapy, or an EGFR tyrosine kinase inhibitor or an ALK inhibitor if sensitizing mutation present; TNBC: platinum-containing chemotherapy; PDAC: fluorouracil (5-FU-), gemcitabine-, or taxane-containing chemotherapy either with or without radiation therapy; SCLC: platinum-containing chemotherapy for limited or extensive stage disease
- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
- Toxicities of prior therapy (except alopecia) should be resolved to =< grade 1 as per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0; patients with long-standing stable grade 2 neuropathy or prior grade 2 treatment-related hypothyroidism requiring treatment, provided free T4 within normal range, may be considered eligible after discussion with the study principal investigator (PI)
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Karnofsky >= 50%)
- Life expectancy of >= 4 months
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin > 9 g/dL
- Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN
- Creatinine =< 1.5 x ULN OR
- Creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal; the creatinine clearance is calculated using Cockcroft-Gault formula
- A urine protein: creatinine ratio of < 1 or < 1 g protein on 24-hour urine collection
- International normalized ration (INR) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed
- Activated partial thromboplastin time (aPTT) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed
- Patients must be able to tolerate oral medications and not have gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
- Adequately controlled thyroid function defined by free T4 within normal range, with no symptoms of thyroid dysfunction
- Adequately controlled blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic) taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of 3 antihypertensive medications; patients who are on 3 antihypertensive medications are highly recommended to be followed by a cardiologist or blood pressure specialist for management of BP while on protocol
Patients who have the following risk factors are considered to be at increased risk for cardiac toxicities, and must have documented left ventricular ejection fraction (LVEF) by echocardiogram greater than institution's lower limit of normal (or 55% if threshold for normal not otherwise specified by institutional guidelines) obtained within 3 months
- Prior treatment with anthracyclines
- Prior treatment with trastuzumab
- A New York Heart Association (NYHA) classification of II controlled with treatment
- Prior central thoracic radiation therapy (RT), including RT to the heart
- History of myocardial infarction within 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)
- The effects of cediranib and olaparib on the developing human fetus are unknown; for this reason, 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 and for the duration of study participation; 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; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 4 months after completion of cediranib and olaparib administration
- Ability to understand and the willingness to sign a written informed consent document
- Age >= 18 years. There is no dosing or adverse event data currently available on the use of cediranib or olaparib in patients < 18 years of age, thus excluding them from enrollment
Exclusion Criteria:
- Patients who have had chemotherapy or RT within 3 weeks prior to start of the study agents, or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
- Patients should not have received any other investigational agents within the past 4 weeks
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should be excluded from this clinical trial, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events (AEs); screening brain MRI (or CT if MRI contraindicated) will be required for patients with recurrent NSCLC, TNBC, or SCLC; brain MRI (or CT if MRI contraindicated) is required for PDAC if clinically suspected by patient's symptoms or neurological exam; should patient found to have brain metastasis, treatment of brain metastasis must precede the participation in this study; for patients with known and treated brain metastases is allowed in this study if they fulfill the following criteria:
- The lesions have improved or remained stable radiographically and clinically for at least 6 weeks after completion of brain irradiation or stereotactic brain radiosurgery and off steroids for at least 6 weeks
- Patients who have received prior inhibitor of VEGF signaling and a poly (ADP-ribose) polymerases (PARP) inhibitor administered in combination; unless administered in combination, patients who received a prior PARP inhibitor or a prior VEGF-signaling inhibitor agent are allowed after discussing with the PI
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib
- Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension
- Current use of natural herbal products or other complementary alternative medications (CAM) or "folk remedies"
- Patients with concomitant or prior invasive malignancies within the past 3 years; subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible
- 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
- History of myocardial infarction within 6 months prior to registration
- History of stroke or transient ischemic attack within 6 months prior to registration
- NYHA classification of III or IV
- Current cardiac arrhythmia requiring concurrent use of anti-arrhythmic drugs
- History of hypertensive crisis or hypertensive encephalopathy within 3 years prior to registration
Clinically significant peripheral vascular disease or abdominal aortic aneurysm (> 5 cm) or aortic dissection; if known history of abdominal aortic aneurysm with >= 4 cm in diameter, all of the following must be met:
- An ultrasound (US) within the last 6 months prior to registration will be required to document that it is =< 5 cm
- Patient must be asymptomatic from the aneurysm
- Blood pressure must be well controlled as defined in this protocol
- A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib (percutaneous/endobronchial biopsies are allowed)
- History of bowel obstruction within 1 month prior to starting study drugs
- History of hemoptysis or any significant bleeding within the last 1 month prior to enrollment
- Presence of cavitation of central pulmonary lesion
- History of abdominal fistula, intra-abdominal abscess, or gastrointestinal perforation within the 3 months prior to enrollment
- Patients may not have current dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)
- Patients may not have evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted; the clinical indication for therapeutic anticoagulation must be clearly documented prior to enrollment and must be discussed with the P.I.; given the increases risk of serious bleeding from cediranib, patients who are on greater than or equal to 2 anti-thrombotic agents, including but not limited to anti-platelet agents (non-steroidal anti-inflammatory drugs [NSAIDs]/aspirin, clopidogrel), heparin, low molecular weight heparin (LMWH), warfarin, and a direct thrombin inhibitor, will be excluded
- Patients may not have features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
- Pregnant women are excluded from this study because olaparib and cediranib have the potential for teratogenic or abortifacient effects; due to the fact that there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with olaparib and cediranib, breastfeeding should be discontinued if the mother is treated with cediranib and olaparib
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cediranib or olaparib; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated; HIV-positive patients with undetectable viral loads and CD4 counts > 300, and not on any antiretroviral therapy may be allowed after discussing with the principle investigator
- Any condition that, in the opinion of the treating investigator would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (cediranib maleate, olaparib)
Patients receive cediranib maleate PO QD on day 1.
Patients undergoing FMISO scan also receive olaparib PO BID beginning the day after the second FMISO scan and the rest of the patients receive olaparib PO BID beginning day 4 of cycle 1.
Cycles repeat every 28 days (35 days for cycle 1) in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Given PO
Other Names:
Given PO
Other Names:
Correlative studies
Other Names:
Correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: Up to 4 weeks after completion of study treatment
|
Measured by Response Evaluation Criteria in Solid Tumors version 1.1.
The exact two-sided 95% confidence interval for the objective response rate will be reported.
|
Up to 4 weeks after completion of study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 4 weeks after completion of study treatment
|
Graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Descriptive statistics, including means, standard deviations, and ranges for continuous parameters, as well as percentages and frequencies for categorical parameters, will be presented.
Adverse medical events will be tabulated.
National Cancer Institute toxicity grade 3 and grade 4 laboratory abnormalities will be listed.
|
Up to 4 weeks after completion of study treatment
|
Progression-free survival
Time Frame: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 4 weeks after completion of study treatment
|
Estimated using the Kaplan-Meier method with the 95% confidence intervals.
Thomas and Grunkemeier confidence interval will be reported.
The possible risk factors will be compared for survival with log-rank test.
For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age and stage of disease on the survival data.
The adjusted p-values of the hazard ratios and the adjusted 95% confidence interval will be reported.
|
The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 4 weeks after completion of study treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of the mutations of deoxyribonucleic acid (DNA) repair genes in each tumor cohort
Time Frame: Up to 2 years
|
In the first 20 endpoint-evaluable patients with non-small cell lung cancer and 20 endpoint-evaluable patients with triple negative breast cancer, the exploratory analyses will be done using Fisher's exact tests, Mann-Whitney U tests or McNemar's test depending on the type of data observed.
|
Up to 2 years
|
Changes in tumor hypoxia by imaging
Time Frame: Baseline to post-cediranib monotherapy
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Measured by 18F-fluoromisonidazole positron emission tomography/computed tomography scans (non-small cell lung cancer).
For the pre- and post-cediranib therapy outcome analysis, paired t- test or Wilcoxon signed-rank test will be applied for the continuous variables.
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Baseline to post-cediranib monotherapy
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Changes in level of circulating tumor deoxyribonucleic acid (ctDNA) (all cohorts)
Time Frame: Baseline to post therapy
|
Will be assessed using paired t- test or Wilcoxon signed-rank.
|
Baseline to post therapy
|
Changes in levels of angiogenesis/ inflammatory markers (angiome panel) (all cohorts)
Time Frame: Baseline to post-therapy
|
Will be assessed using paired t- test or Wilcoxon signed-rank.
|
Baseline to post-therapy
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph W Kim, Yale University Cancer Center LAO
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Pancreatic Diseases
- Breast Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Adenocarcinoma
- Small Cell Lung Carcinoma
- Pancreatic Neoplasms
- Carcinoma, Small Cell
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Olaparib
- Maleic acid
- Poly(ADP-ribose) Polymerase Inhibitors
- Cediranib
- Misonidazole
Other Study ID Numbers
- NCI-2015-01097 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- UM1CA186689 (U.S. NIH Grant/Contract)
- UM1CA186644 (U.S. NIH Grant/Contract)
- 1604017576
- 9881 (Other Identifier: CTEP)
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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