| ID | Type | Description | Link |
|---|---|---|---|
| 03-C-0284 | Other Identifier | Clinical Center (CC), National Institutes of Health (NIH) | |
| 030284 | Other Identifier | Clinical Center (CC), National Institutes of Health (NIH) |
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The purpose of this study is three-fold: 1) to examine the ability of the experimental drug tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the cancer drug docetaxel; and 3) evaluate the effectiveness of combination treatment with tariquidar and docetaxel in treating patients with lung, ovarian, or cervical cancer.
Patients 18 years of age and older with recurrent or metastatic (spreading) lung, cervical, or ovarian cancer who cannot benefit from any standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination; review of pathology slides; blood and urine tests; imaging tests, including computed tomography (CT) or magnetic resonance imaging (MRI) scans; chest x-ray, electrocardiogram (EKG); and possibly echocardiogram.
Participants will undergo the following tests and procedures:
Blood draw. Blood is drawn before treatment begins to establish baseline levels for future blood tests. Blood counts are done twice weekly after chemotherapy begins.
Central venous catheter placement. A plastic tube is put into a major vein in the chest. It is used to give the study drugs or other medications, including antibiotics and blood transfusions, if needed, and to withdraw blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room. It can stay in the body for months or be removed after each treatment is completed.
Chemotherapy. Treatment cycles are 21 days. Both drugs are given on day 1 of each cycle. First, tariquidar is given as a 30-minute infusion. One hour after the tariquidar infusion, docetaxel is infused over 1 hour. (For the first cycle only, docetaxel is given in divided doses one week apart and tariquidar is administered on either day 1 or day 8. The order of tariquidar administration is randomized to generate optimal pharmacokinetic data. Patients will be hospitalized for several days during this cycle to gather research data). The tariquidar dose remains the same throughout the study. Docetaxel may be increased or decreased from cycle to cycle, based on side effects.
Intrinsic and acquired drug resistance remain major obstacles in the treatment of cancer. Accumulating evidence indicates that in some malignancies P-glycoprotein (Pgp) can confer resistance, and that its reversal can improve therapeutic outcome. Clinical trials investigating Pgp antagonists have been hampered by the occurrence of unpredictable pharmacokinetic interactions, which have required dose reductions of the chemotherapeutic agents to avert excessive toxicity. Tariquidar (XR9576) is a new Pgp antagonist that is more potent and has prolonged activity. Phase I trials with paclitaxel, vinorelbine, and docetaxel have demonstrated that tariquidar (XR9576) has minimal pharmacokinetic interactions while surrogate studies have confirmed in vivo inhibition of Pgp-mediated drug transport.This study seeks to determine the pharmacokinetic interaction, if any between docetaxel and tariquidar and to evaluate the potential for activity in lung, ovarian, primary peritoneal, fallopian tube and cervical cancers. Renal cell cancer has been added in a 3/1/06 amendment. The secondary goal is to evaluate the impact of tariquidar on uptake of (99m)Tc-sestamibi in recurrent or metastatic tumors of patients with lung, ovarian, renal or cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pts who received docetaxel on day 1, 8, & tariquidar day 8,22 | Experimental | Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose. |
|
| Pts who received docetaxel on days 1, 8, & tariquidar day 1,22 | Experimental | Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean of Maximum Concentration of the Drug (Cmax) | In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared. | 24 hours |
| The Number of Participants With Adverse Events. | Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | 4 yrs 8-11 months |
| Geometric Mean of Area Under Curve (AUC0)-24 | 24 hours | |
| Clinical Response Rate | Response is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/- 20 mm with conventional techniques (CT, MRI, xray) or as >/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter <20 mm with conventional techniques or <10 mm using spiral CT. | 4 years, 8-11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar | A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E Bates, M.D. | NCI, NIH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4855907 | Background | Ling V, Thompson LH. Reduced permeability in CHO cells as a mechanism of resistance to colchicine. J Cell Physiol. 1974 Feb;83(1):103-16. doi: 10.1002/jcp.1040830114. No abstract available. | |
| 3856953 | Background | Akiyama S, Fojo A, Hanover JA, Pastan I, Gottesman MM. Isolation and genetic characterization of human KB cell lines resistant to multiple drugs. Somat Cell Mol Genet. 1985 Mar;11(2):117-26. doi: 10.1007/BF01534700. |
| Label | URL |
|---|---|
| Medline Plus | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22 | Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose. |
| FG001 | Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22 | Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22 | Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean of Maximum Concentration of the Drug (Cmax) | In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared. | Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Data were evaluable in 39 patients. Paired data from 31 participants were evaluable. | Posted | Geometric Mean | 95% Confidence Interval | Cmax (ng/mL) | 24 hours |
|
4 years and 11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22 | Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BLOOD/BONE MARROW:: Leukocytes (total WBC) | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AUDITORY/HEARING:: Middle ear/hearing | Ear and labyrinth disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan E. Bates, M.D. | National Cancer Institute, National Institutes of Health | 301-402-1357 | BatesS@mail.nih.gov |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C402343 | tariquidar |
| D017256 | Technetium Tc 99m Sestamibi |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| tariquidar | Drug | Patients receive tariquidar intravenous (IV) over 30 minutes on days 8 and 22. |
|
|
| 99mTc-sestamibi imaging | Other | Bolus injection of 29 mCi of 99mTc-sestamibi intravenously for each imaging study. |
|
|
| 3 - 24 hours |
| Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue | 99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. | 3-24 hours |
| 6579344 | Background | Beck WT, Cirtain MC, Lefko JL. Energy-dependent reduced drug binding as a mechanism of Vinca alkaloid resistance in human leukemic lymphoblasts. Mol Pharmacol. 1983 Nov;24(3):485-92. |
| 21081657 | Result | Kelly RJ, Draper D, Chen CC, Robey RW, Figg WD, Piekarz RL, Chen X, Gardner ER, Balis FM, Venkatesan AM, Steinberg SM, Fojo T, Bates SE. A pharmacodynamic study of docetaxel in combination with the P-glycoprotein antagonist tariquidar (XR9576) in patients with lung, ovarian, and cervical cancer. Clin Cancer Res. 2011 Feb 1;17(3):569-80. doi: 10.1158/1078-0432.CCR-10-1725. Epub 2010 Nov 16. |
| Drug Information | View source |
| U.S. FDA Resources | View source |
| BG001 |
| Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22 |
Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
|
|
| Primary | The Number of Participants With Adverse Events. | Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | Posted | Number | participants | 4 yrs 8-11 months |
|
|
|
| Primary | Geometric Mean of Area Under Curve (AUC0)-24 | Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Pharmacokinetic data were evaluable in 39 patients. Paired data from 31 participants were evaluable. | Posted | Geometric Mean | 95% Confidence Interval | h*ng/mL | 24 hours |
|
|
|
|
| Primary | Clinical Response Rate | Response is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/- 20 mm with conventional techniques (CT, MRI, xray) or as >/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter <20 mm with conventional techniques or <10 mm using spiral CT. | Posted | Number | Percentage of participants | 4 years, 8-11 months |
|
|
|
| Secondary | Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar | A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan. | Percent increase in sestamibi AUC in liver after tariquidar. | Posted | Median | Full Range | percent increase in sestamibi AUC | 3 - 24 hours |
|
|
|
| Secondary | Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue | 99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. | Posted | Median | Full Range | Percent | 3-24 hours |
|
|
|
| 6 |
| 23 |
| 23 |
| 23 |
| EG001 | Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22 | Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose. | 8 | 25 | 25 | 25 |
| CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia) | General disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS:: | General disorders | MedDRA10/CTCv2.0 | Systematic Assessment | Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) |
|
| CONSTITUTIONAL SYMPTOMS:: Rigors, chills | General disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Alopecia | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| MUSCULOSKELETAL:: Musculoskeletal-Other (Specify,musculoskeletal-lethargic) | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Dizziness/lightheadedness | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PULMONARY:: Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PULMONARY:: Pulmonary-Other (Specify,clinical deterioration) | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CARDIOVASCULAR (GENERAL):: Hypotension | Cardiac disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CARDIOVASCULAR (GENERAL):: Thrombosis/embolism | Cardiac disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Anorexia | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEMORRHAGE:: Rectal bleeding/hematochezia | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEPATIC:: Alkaline phosphatase | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase) | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase) | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| INFECTION/FEBRILE NEUTROPENIA:: Febrile neutropenia (fever of unknown origin without clinically or m | Infections and infestations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hyponatremia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Depressed level of consciousness | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Mood alteration-anxiety, agitation | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PULMONARY:: Cough | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| Urinary frequency/urgency | Renal and urinary disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Hemoglobin | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Leukocytes (total WBC) | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Lymphopenia | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Platelets | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Transfusion: pRBCs | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia | Cardiac disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CARDIOVASCULAR (GENERAL):: Edema | Cardiac disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CARDIOVASCULAR (GENERAL):: Hypertension | Cardiac disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CARDIOVASCULAR (GENERAL):: Hypotension | Cardiac disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CARDIOVASCULAR (GENERAL):: Phlebitis (superficial) | Cardiac disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CARDIOVASCULAR (GENERAL):: Thrombosis/embolism | Cardiac disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| COAGULATION:: Partial thromboplastin time (PTT) | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| COAGULATION:: Prothrombin time (PT) | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia) | General disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as AGC< | General disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS:: Rigors, chills | General disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS:: Weight loss | General disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Alopecia | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify,_____) | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment | dermatology/skin: red peeling skin-face |
|
| DERMATOLOGY/SKIN:: Dry skin | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Flushing | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Hand-foot skin reaction | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Injection site reaction | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Nail changes | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Radiation dermatitis | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Rash/desquamation | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Anorexia | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Constipation | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Dehydration | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Diarrhea patients without colostomy | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Dyspepsia/heartburn | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing) | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Flatulence | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Gastrointestinal-Other (Specify,_____) | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment | gastrointestinal: tooth fracture |
|
| GASTROINTESTINAL:: Mouth dryness | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Nausea | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Stomatitis/pharyngitis (oral/pharyngeal mucositis) | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Taste disturbance (dysgeusia) | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Vomiting | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEMORRHAGE:: Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEPATIC:: Alkaline phosphatase | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEPATIC:: Bilirubin | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEPATIC:: Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase) | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase) | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection | Infections and infestations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| INFECTION/FEBRILE NEUTROPENIA:: | Infections and infestations | MedDRA10/CTCv2.0 | Systematic Assessment | Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0x10e9/L, fever >=38.5 degrees C) |
|
| INFECTION/FEBRILE NEUTROPENIA:: | Infections and infestations | MedDRA10/CTCv2.0 | Systematic Assessment | Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L) |
|
| INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia | Infections and infestations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Bicarbonate | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: CPK (creatine phosphokinase) | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hypercalcemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hyperglycemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hyperkalemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hypermagnesemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hypernatremia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hypocalcemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hypoglycemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hypomagnesemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hyponatremia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hypophosphatemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| MUSCULOSKELETAL:: Muscle weakness (not due to neuropathy) | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Ataxia (incoordination) | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Confusion | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Depressed level of consciousness | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Dizziness/lightheadedness | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Insomnia | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Mood alteration-depression | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Hypokalemia | Metabolism and nutrition disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Neuropathy-sensory | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Seizure(s) | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Syncope (fainting | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Vertigo | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| OCULAR/VISUAL:: Conjunctivitis | Eye disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| OCULAR/VISUAL:: Dry eye | Eye disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| OCULAR/VISUAL:: Tearing (watery eyes) | Eye disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Abdominal pain or cramping | Reproductive system and breast disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Bone pain | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Chest pain (non-cardiac and non-pleuritic) | General disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Myalgia (muscle pain) | Musculoskeletal and connective tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralg | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Pain-Other (Specify,___) | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment | Back pain Hips + Legs pain-lumbar pain: back pain pain: sore throat pain: chest tube site pain: L flank lower pain: lower back pain pain: lower back |
|
| PULMONARY:: Cough | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PULMONARY:: Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PULMONARY:: Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PULMONARY:: Pulmonary-Other (Specify,___) | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment | pleural effusion (malignant) |
|
| PULMONARY:: Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| RENAL/GENITOURINARY:: Creatinine | Renal and urinary disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PULMONARY:: Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| RENAL/GENITOURINARY:: Urinary frequency/urgency | Renal and urinary disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Headache | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| ALLERGY/IMMUNOLOGY:: Allergy-Other (Specify,_____) | Immune system disorders | MedDRA10/CTCv2.0 | Systematic Assessment | allergy:reaction to tariquidar |
|
| BLOOD/BONE MARROW:: Hemoglobin | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| CARDIOVASCULAR (ARRHYTHMIA):: Palpitations | Cardiac disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Bruising (in absence of grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Pruritus | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Wound-non-infectious | Skin and subcutaneous tissue disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Mucositis due to radiation | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| GASTROINTESTINAL:: Nausea | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEMORRHAGE:: CNS hemorrhage/bleeding | Blood and lymphatic system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEMORRHAGE:: Hematuria (in the absence of vaginal bleeding) | Renal and urinary disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| HEMORRHAGE:: Rectal bleeding/hematochezia | Gastrointestinal disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| INFECTION/FEBRILE NEUTROPENIA:: Infection/Febrile Neutropenia-Other (Specify,____) | Infections and infestations | MedDRA10/CTCv2.0 | Systematic Assessment | infection-thrush |
|
| METABOLIC/LABORATORY:: Hyperuricemia | Investigations | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| NEUROLOGY:: Mood alteration-anxiety, agitation | Nervous system disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| OCULAR/VISUAL:: Ocular/Visual-Other (Specify,___) | Eye disorders | MedDRA10/CTCv2.0 | Systematic Assessment | uveitis |
|
| OCULAR/VISUAL:: Vision-blurred vision | Eye disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Earache (otalgia) | Ear and labyrinth disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| PAIN:: Pelvic pain | Reproductive system and breast disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| RENAL/GENITOURINARY:: Dysuria (painful urination) | Renal and urinary disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
| RENAL/GENITOURINARY:: Urinary retention | Renal and urinary disorders | MedDRA10/CTCv2.0 | Systematic Assessment |
|
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D009570 | Nitriles |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
| Both Groups (C1D1 + C1D8) |
|