ID

32395

Description

Safety Study of ABT-888 Plus Topotecan Hydrochloride to Treat Patients With Solid Tumors and Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT00553189

Link

https://clinicaltrials.gov/show/NCT00553189

Keywords

Versions (1)
  1. 10/30/18 10/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 30, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Solid Tumors NCT00553189

English

Eligibility Solid Tumors NCT00553189

1 forms  
Criteria
Description

Criteria

1. patients with histologically documented solid tumors and lymphoid malignancies (lymphoma and cll) who are refractory to standard therapy or who have no acceptable standard treatment options. patients with lymphoid malignancies will be eligible if their disease has progressed following standard therapy and if stem cell transplantation is not indicated or has been refused.
Description

Solid Neoplasm | Malignant lymphoid neoplasm | Lymphoma | Chronic Lymphocytic Leukemia | Standard therapy refractory | Standard therapy Absent | Disease Progression Post Standard therapy | Indication Absent Stem cell transplantation | Stem cell transplantation Refused

Data type

boolean

Alias
UMLS CUI [1]
C0280100
UMLS CUI [2]
C0746336
UMLS CUI [3]
C0024299
UMLS CUI [4]
C0023434
UMLS CUI [5,1]
C2936643
UMLS CUI [5,2]
C0205269
UMLS CUI [6,1]
C2936643
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0242656
UMLS CUI [7,2]
C0687676
UMLS CUI [7,3]
C2936643
UMLS CUI [8,1]
C3146298
UMLS CUI [8,2]
C0332197
UMLS CUI [8,3]
C1504389
UMLS CUI [9,1]
C1504389
UMLS CUI [9,2]
C1705116
2. any prior therapy must have been completed greater than or equal to 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels (ctcae grade less than or equal to 1) from prior toxicity. prior radiation or surgery should have been completed greater than or equal to 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels. patients must be greater than or equal to 2 weeks since any investigational agent administered as part of a phase 0 study, and should have recovered to eligibility levels from any toxicities.
Description

Prior Therapy Completed | Toxicity Patient recovered CTCAE Grades | Prior radiation therapy Completed | Operative Surgical Procedures Completed | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1115804
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0205197
UMLS CUI [5]
C0013230
3. age greater than or equal to 18 years. because no dosing or adverse event data are currently available on the use of abt-888 in patients less than 18 years of age, children are excluded from this study, but may be eligible for future pediatric phase i combination trials.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60 percent).
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
5. life expectancy of greater than 3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
6. patients must have normal organ and marrow function as defined below:
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
absolute neutrophil count greater than or equal to 1,500/mcl
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelets greater than or equal to 100,000/mcl
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin less than 1.5 times institutional upper limit of normal
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
ast(sgot)/alt(sgpt) less than or equal to 2.5 times institutional upper limit of normal
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine less than 1.5 times institutional upper limit of normal
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
creatinine clearance greater than or equal to 60 ml/min for patients with creatinine levels above institutional normal.
Description

Creatinine clearance measurement | Creatinine increased

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0151578
7. the effects of abt-888 on the developing human fetus are unknown. for this reason and because topotecan hydrochloride used in this trial are known to be teratogenic, 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, for the duration of study participation, and for 30 days after completion of study. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Description

ABT 888 Effects Fetus Unknown | Topotecan Hydrochloride Teratogenic effects | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Pregnancy Treating Physician Informed

Data type

boolean

Alias
UMLS CUI [1,1]
C1831920
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0015965
UMLS CUI [1,4]
C0439673
UMLS CUI [2,1]
C0886549
UMLS CUI [2,2]
C0232910
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C2985296
UMLS CUI [6]
C0004764
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0032961
UMLS CUI [8,2]
C1710470
UMLS CUI [8,3]
C1522154
8. ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. patients must be greater than or equal to 2 weeks since any investigational agent administered as part of a phase 0 study, and should have recovered to eligibility levels from any toxicities.
Description

Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin | Adverse reaction to drug Recovery Lacking | Investigational New Drugs | Toxicity Patient recovered CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5,1]
C0041755
UMLS CUI [5,2]
C2004454
UMLS CUI [5,3]
C0332268
UMLS CUI [6]
C0013230
UMLS CUI [7,1]
C0600688
UMLS CUI [7,2]
C1115804
UMLS CUI [7,3]
C1516728
patients who have been administered abt-888 as part of a single or limited dosing study, such as a phase 0 study, should not be excluded from participating in this study solely because of receiving prior abt-888.
Description

Exception ABT 888 Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C1831920
UMLS CUI [1,3]
C0205156
patients who have received prior tpt should not be excluded solely because of receiving prior tpt.
Description

Exception Topotecan Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0205156
2. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, prolonged qtc interval (greater than msec), or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Prolonged QTc interval | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6]
C1560305
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0525058
3. patients with known brain mestastases or a history of seizures are excluded from this clinical trial.
Description

Metastatic malignant neoplasm to brain | Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0036572
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Similar models

Eligibility Solid Tumors NCT00553189

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Solid Neoplasm | Malignant lymphoid neoplasm | Lymphoma | Chronic Lymphocytic Leukemia | Standard therapy refractory | Standard therapy Absent | Disease Progression Post Standard therapy | Indication Absent Stem cell transplantation | Stem cell transplantation Refused
Item
1. patients with histologically documented solid tumors and lymphoid malignancies (lymphoma and cll) who are refractory to standard therapy or who have no acceptable standard treatment options. patients with lymphoid malignancies will be eligible if their disease has progressed following standard therapy and if stem cell transplantation is not indicated or has been refused.
boolean
C0280100 (UMLS CUI [1])
C0746336 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
C0023434 (UMLS CUI [4])
C2936643 (UMLS CUI [5,1])
C0205269 (UMLS CUI [5,2])
C2936643 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0242656 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C2936643 (UMLS CUI [7,3])
C3146298 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C1504389 (UMLS CUI [8,3])
C1504389 (UMLS CUI [9,1])
C1705116 (UMLS CUI [9,2])
Prior Therapy Completed | Toxicity Patient recovered CTCAE Grades | Prior radiation therapy Completed | Operative Surgical Procedures Completed | Investigational New Drugs
Item
2. any prior therapy must have been completed greater than or equal to 4 weeks prior to enrollment on protocol and the participant must have recovered to eligibility levels (ctcae grade less than or equal to 1) from prior toxicity. prior radiation or surgery should have been completed greater than or equal to 4 weeks prior to study enrollment and all associated toxicities resolved to eligibility levels. patients must be greater than or equal to 2 weeks since any investigational agent administered as part of a phase 0 study, and should have recovered to eligibility levels from any toxicities.
boolean
C1514463 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0013230 (UMLS CUI [5])
Age
Item
3. age greater than or equal to 18 years. because no dosing or adverse event data are currently available on the use of abt-888 in patients less than 18 years of age, children are excluded from this study, but may be eligible for future pediatric phase i combination trials.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
4. ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60 percent).
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
5. life expectancy of greater than 3 months.
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
6. patients must have normal organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absolute neutrophil count
Item
absolute neutrophil count greater than or equal to 1,500/mcl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets greater than or equal to 100,000/mcl
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin less than 1.5 times institutional upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast(sgot)/alt(sgpt) less than or equal to 2.5 times institutional upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine less than 1.5 times institutional upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Creatinine clearance measurement | Creatinine increased
Item
creatinine clearance greater than or equal to 60 ml/min for patients with creatinine levels above institutional normal.
boolean
C0373595 (UMLS CUI [1])
C0151578 (UMLS CUI [2])
ABT 888 Effects Fetus Unknown | Topotecan Hydrochloride Teratogenic effects | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Pregnancy Treating Physician Informed
Item
7. the effects of abt-888 on the developing human fetus are unknown. for this reason and because topotecan hydrochloride used in this trial are known to be teratogenic, 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, for the duration of study participation, and for 30 days after completion of study. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C1831920 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0015965 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
C0886549 (UMLS CUI [2,1])
C0232910 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C2985296 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0032961 (UMLS CUI [8,1])
C1710470 (UMLS CUI [8,2])
C1522154 (UMLS CUI [8,3])
Informed Consent
Item
8. ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Nitrosoureas | Mitomycin | Adverse reaction to drug Recovery Lacking | Investigational New Drugs | Toxicity Patient recovered CTCAE Grades
Item
1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. patients must be greater than or equal to 2 weeks since any investigational agent administered as part of a phase 0 study, and should have recovered to eligibility levels from any toxicities.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0041755 (UMLS CUI [5,1])
C2004454 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
C0013230 (UMLS CUI [6])
C0600688 (UMLS CUI [7,1])
C1115804 (UMLS CUI [7,2])
C1516728 (UMLS CUI [7,3])
Exception ABT 888 Previous
Item
patients who have been administered abt-888 as part of a single or limited dosing study, such as a phase 0 study, should not be excluded from participating in this study solely because of receiving prior abt-888.
boolean
C1705847 (UMLS CUI [1,1])
C1831920 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Exception Topotecan Previous
Item
patients who have received prior tpt should not be excluded solely because of receiving prior tpt.
boolean
C1705847 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Comorbidity Uncontrolled | Communicable Diseases | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Prolonged QTc interval | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
2. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, prolonged qtc interval (greater than msec), or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C1560305 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
Metastatic malignant neoplasm to brain | Seizures
Item
3. patients with known brain mestastases or a history of seizures are excluded from this clinical trial.
boolean
C0220650 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
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