Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 11-C-0150 |
Not provided
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Not provided
The study closed prematurely due to discontinuation of drug supply.
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Background:
- PU-H71 is an experimental drug used to treat cancer. It works by blocking a protein in tumors. When this protein is blocked, it affects other proteins inside the cell that cancers need to grow. Researchers want to study whether PU-H71 is a safe and effective way to treat solid tumors and non-Hodgkin's lymphoma.
Objectives:
- To evaluate the safety and effectiveness of PU-H71 in solid tumors and non-Hodgkin's lymphoma that have not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age who have solid tumors or non-Hodgkin's lymphoma that have not responded to standard treatments.
Design:
Background:
-PU-H71 is a synthetic HSP90 inhibitor which can bind both open and closed conformations of HSP90. It demonstrates extended tumor retention and client protein degradation, while being rapidly cleared from normal tissues. It has shown complete tumor responses and retained sensitivity to retreatment in vivo.
Primary Objectives:
Secondary Objectives:
Eligibility:
-Study participants must have histologically confirmed solid tumor malignancy or low-grade non-Hodgkin s lymphoma that has progressed or recurred after at least one line of chemotherapy or for which no standard treatment option exists; no therapy within 4 weeks prior to entering the study; age greater than or equal to 18 years; Eastern Cooperative Oncology Group (ECOG) less than or equal to 2; life expectancy > 3 months; and adequate organ and marrow function. Patients entering on the expansion cohort at the MTD must have disease amenable to biopsy with willingness to undergo pre- and post-treatment biopsies.
Study Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PU-H71 | Experimental | PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PU-H71 | Drug | PU-H71 is a synthetic HSP90 inhibitor which can bind both open and closed conformations of HSP90. It demonstrates extended tumor retention and client protein degradation, while being rapidly cleared from normal tissues. It has shown complete tumor responses and retained sensitivity to retreatment in vivo. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs) | A DLT was defined as an adverse event that occurred during cycle 1, was thought to be related to study drug administration, and met one of the following criteria: grade ≥ 3 non-hematologic toxicities (except diarrhea, nausea, vomiting without maximal supportive therapy; alopecia), grade 4 hematologic toxicities (except lymphopenia), and grade 2 ocular toxicity that did not resolve to ≤ grade 1 within 2 weeks. Occurrence of a DLT resulted in a dose reduction following resolution to grade ≤ 2. No more than 2 dose reductions were allowed per patient on study. | Cycle 1 (21 days) |
| Number of Participants With Adverse Events Possibly, Probably, or Definitely Related to Study Drug | Severity of adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 Mild adverse event (AE), Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, and Grade 5 Death related to AE. | 3 years and two months and 11 days |
| Maximum Tolerated Dose (MTD) of PU-H71 | The MTD is the dose level at which no more than 1 of 6 patients experience DLT during the first cycle of treatment, and the dose below that at which at least 2 (of ≤ 6) patients have DLT as a result of the drug. | Cycle 1 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) | Number of Participants According to Best Response Per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by computed tomography (CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions. |
Not provided
Patients must be greater than or equal to 2 weeks since any prior administration of a study drug in a Phase 0 study (also referred to as a pre-Phase I study where a sub-therapeutic dose of drug is administered). Patients must have recovered to eligibility levels from prior toxicity or adverse events. Patients receiving bisphosphonates for any cancer are eligible to participate.
Age greater than or equal to 18 years.
An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
Life expectancy > 3 months.
Patients must have normal or adequate organ and marrow function as defined below:
The effects of PU-H71 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 2 months after completion of study. Women of childbearing potential must have a negative pregnancy test within 72 hours of enrollment in order to be eligible. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in the study, the treating physician should be notified immediately. Because there is an unknown but potential risk to nursing infants secondary to treatment of the mother with PU-H71, breastfeeding should be discontinued if the mother is treated with PU-H71.
During the expansion phase of the protocol, patients must have:
Ability to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Alice P Chen, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19697319 | Background | Zuehlke A, Johnson JL. Hsp90 and co-chaperones twist the functions of diverse client proteins. Biopolymers. 2010 Mar;93(3):211-7. doi: 10.1002/bip.21292. | |
| 19850405 | Background | Fukuyo Y, Hunt CR, Horikoshi N. Geldanamycin and its anti-cancer activities. Cancer Lett. 2010 Apr 1;290(1):24-35. doi: 10.1016/j.canlet.2009.07.010. Epub 2009 Oct 21. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PU-H71, 10 mg/m^2 | PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG001 | PU-H71, 20 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG002 | PU-H71, 40 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG003 | PU-H71, 60 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG004 | PU-H71, 80 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG005 | PU-H71, 110 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG006 | PU-H71, 150 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG007 | PU-H71, 200 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG008 | PU-H71, 266 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG009 | PU-H71, 354 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| FG010 | PU-H71, 470 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PU-H71 | PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs) | A DLT was defined as an adverse event that occurred during cycle 1, was thought to be related to study drug administration, and met one of the following criteria: grade ≥ 3 non-hematologic toxicities (except diarrhea, nausea, vomiting without maximal supportive therapy; alopecia), grade 4 hematologic toxicities (except lymphopenia), and grade 2 ocular toxicity that did not resolve to ≤ grade 1 within 2 weeks. Occurrence of a DLT resulted in a dose reduction following resolution to grade ≤ 2. No more than 2 dose reductions were allowed per patient on study. | Posted | Count of Participants | Participants | No | Cycle 1 (21 days) |
|
3 years and two months and 11 days
Adverse events were collected and analyzed by dose level.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PU-H71, 10 mg/m^2 | PU-H71 will be administered intravenous (IV) over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain - cramping | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shivaani Kummar | Stanford University School of Medicine | 650-724-9084 | skummar@stanford.edu |
Not provided
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C526550 | 9H-purine-9-propanamine, 6-amino-8-((6-iodo-1,3-benzodioxol-5-yl)thio)-N-(1-methylethyl)- |
Not provided
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|
| Baseline and every 6 weeks up to 18 weeks |
| Number of Days on Treatment | up to 126 days |
| Maximum Observed Plasma Concentration (Cmax) | The maximum concentration (Cmax) was determined by visual inspection of the concentration versus time data. | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
| Terminal Half-life (T1/2) | The terminal half-life (t1/2) was derived from the plasma concentration vs. time data. | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
| Area Under the Concentration-Time Curve From Time 0 to 24 Hours [AUC(0-24)] | Area Under the Concentration-Time Curve From Time 0 to 24 Hours was estimated by trapezoidal rule calculations | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
| Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] | Area Under the Concentration-Time Curve From Time 0 to Infinity was estimated by trapezoidal rule calculations | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
| Urinary Excretion (%) | Elimination of the drug was investigated by analysis of an aliquot of the total urine collected in 24 h. | Every void post-treatment on day 1 of cycle 1 |
| Clearance | Clearance was calculated from drug dose and AUC(0-∞). | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
| 8617772 | Background | Chavany C, Mimnaugh E, Miller P, Bitton R, Nguyen P, Trepel J, Whitesell L, Schnur R, Moyer J, Neckers L. p185erbB2 binds to GRP94 in vivo. Dissociation of the p185erbB2/GRP94 heterocomplex by benzoquinone ansamycins precedes depletion of p185erbB2. J Biol Chem. 1996 Mar 1;271(9):4974-7. doi: 10.1074/jbc.271.9.4974. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Prior Therapies | Mean | Full Range | prior therapies |
|
| Diagnosis | Count of Participants | Participants | No |
|
| OG001 |
| PU-H71, 20 mg/m^2 |
PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| OG002 | PU-H71, 40 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| OG003 | PU-H71, 60 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| OG004 | PU-H71, 80 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| OG005 | PU-H71, 110 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| OG006 | PU-H71, 150 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| OG007 | PU-H71, 200 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| OG008 | PU-H71, 266 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| OG009 | PU-H71, 354 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
| OG010 | PU-H71, 470 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days |
|
|
| Primary | Number of Participants With Adverse Events Possibly, Probably, or Definitely Related to Study Drug | Severity of adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 Mild adverse event (AE), Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, and Grade 5 Death related to AE. | Posted | Count of Participants | Participants | No | 3 years and two months and 11 days |
|
|
|
| Primary | Maximum Tolerated Dose (MTD) of PU-H71 | The MTD is the dose level at which no more than 1 of 6 patients experience DLT during the first cycle of treatment, and the dose below that at which at least 2 (of ≤ 6) patients have DLT as a result of the drug. | Posted | Number | mg/m^2 | Cycle 1 (21 days) |
|
|
|
| Secondary | Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) | Number of Participants According to Best Response Per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by computed tomography (CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions. | All participants who continued further treatment and did not start an alternative treatment were considered evaluable for response. | Posted | Count of Participants | Participants | No | Baseline and every 6 weeks up to 18 weeks |
|
|
|
| Secondary | Number of Days on Treatment | All participants who continued further treatment and did not start an alternative treatment were considered evaluable for response. | Posted | Median | Full Range | days | up to 126 days |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) | The maximum concentration (Cmax) was determined by visual inspection of the concentration versus time data. | Posted | Mean | Standard Deviation | µM | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
|
|
|
| Secondary | Terminal Half-life (T1/2) | The terminal half-life (t1/2) was derived from the plasma concentration vs. time data. | Posted | Mean | Standard Deviation | hours | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time 0 to 24 Hours [AUC(0-24)] | Area Under the Concentration-Time Curve From Time 0 to 24 Hours was estimated by trapezoidal rule calculations | Posted | Mean | Standard Deviation | µM*min | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] | Area Under the Concentration-Time Curve From Time 0 to Infinity was estimated by trapezoidal rule calculations | Posted | Mean | Standard Deviation | µM*min | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
|
|
|
| Secondary | Urinary Excretion (%) | Elimination of the drug was investigated by analysis of an aliquot of the total urine collected in 24 h. | Posted | Mean | Standard Deviation | percent of dose recovered | Every void post-treatment on day 1 of cycle 1 |
|
|
|
| Secondary | Clearance | Clearance was calculated from drug dose and AUC(0-∞). | Posted | Mean | Standard Deviation | L/h/kg | Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1. |
|
|
|
| 1 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | PU-H71, 20 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 0 | 1 | 1 | 1 | 1 | 1 |
| EG002 | PU-H71, 40 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 1 | 1 | 0 | 1 | 1 | 1 |
| EG003 | PU-H71, 60 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 1 | 1 | 0 | 1 | 1 | 1 |
| EG004 | PU-H71, 80 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 0 | 2 | 0 | 2 | 2 | 2 |
| EG005 | PU-H71, 110 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 0 | 3 | 0 | 3 | 3 | 3 |
| EG006 | PU-H71, 150 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 0 | 1 | 0 | 1 | 1 | 1 |
| EG007 | PU-H71, 200 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 0 | 2 | 0 | 2 | 2 | 2 |
| EG008 | PU-H71, 266 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 1 | 1 | 0 | 1 | 1 | 1 |
| EG009 | PU-H71, 354 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 0 | 3 | 1 | 3 | 3 | 3 |
| EG010 | PU-H71, 470 mg/m^2 | PU-H71 will be administered IV over one hour, once weekly, 2 weeks out of 3, (i.e., on days 1 and 8) every 21 days | 0 | 1 | 1 | 1 | 1 | 1 |
| Lung Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| CPK increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Electrocardiogram QT corrected interval prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flank pain - Left | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemoglobinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection, device related | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Night blindness: intermittent | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity- Right Ankle | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral vascular dis. | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Grade 2 Aspartate Aminotransferase |
|
| Grade 2 Atrioventricular Block First Degree |
|
| Grade 2 Blood Bilirubin Increased |
|
| Grade 2 Fatigue |
|
| Grade 2 Headache |
|
| Grade 2 Lymphopenia |
|
| Grade 2 Nausea |
|
| Grade 2 Sinus Bradycardia |
|
| Grade 3 Vomiting |
|
| Partial Response |
|
| Stable Disease |
|
| Progression of Disease |
|