Malignant solid tumour Advanced | Lymphoma Advanced | Standard therapy Unavailability
Item
part a: subjects with histologically or cytologically confirmed malignant advanced solid tumors or lymphoma, for whom either no standard therapy should be available which may convey clinical benefit, or
boolean
C1698088 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0024299 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
Malignant solid tumour Advanced | Lymphoma Advanced | Standard therapy Unavailability | Prior Chemotherapy | Neoplasm Metastasis | Carboplatin Standard of Care
Item
part b: subjects with histologically or cytologically confirmed malignant advanced solid tumors or lymphoma, for whom no standard therapy should be available which may convey clinical benefit and/or patients must have progressed after at least 1 prior chemotherapy regimen in the metastatic setting, and carboplatin would be considered standard of care.
boolean
C1698088 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0024299 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4])
C0027627 (UMLS CUI [5])
C0079083 (UMLS CUI [6,1])
C2936643 (UMLS CUI [6,2])
Ovarian Carcinoma Severe Advanced Locally Metastatic | Therapeutic procedure Platinum-based Drug | Disease Progression
Item
part c: subjects with advanced (locally advanced incurable or metastatic) histologically or cytologically confirmed high-grade serous ovarian cancer (high nuclear grades 2 or 3). subjects should have either platinum-refractory (disease progression during initial platinum therapy) or platinum-resistant (disease progression <6 months after completion of platinum therapy) disease.
boolean
C0029925 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1517928 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C2266918 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
Measurable Disease Response Evaluation Criteria in Solid Tumors
Item
measurable disease according to recist criteria (version 1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
WHO performance status scale
Item
who performance status of 0 or 1
boolean
C1298650 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of ≥12 weeks
boolean
C0023671 (UMLS CUI [1])
Index Hematologic | Index Biochemical
Item
hematological and biochemical indices within acceptable ranges at screening.
boolean
C0918012 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0918012 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
Therapeutic radiology procedure | Palliative Radiation Therapy | Hormone Therapy | Immunotherapy | Chemotherapy Regimen | Nitrosourea Compounds | Mitomycin | Investigational New Drugs
Item
radiotherapy, unless brief course for palliative therapy, endocrine therapy, immunotherapy, or chemotherapy during the 4 weeks (6 weeks for nitrosoureas and mitomycin-c, and 4 weeks for investigational medicinal products) or 4 drug half-lives before first dose of study drug, whichever is greater
boolean
C1522449 (UMLS CUI [1])
C3898008 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
C0028210 (UMLS CUI [6])
C0002475 (UMLS CUI [7])
C0013230 (UMLS CUI [8])
Prior Therapy Carboplatin
Item
part b: more than 6 cycles of prior therapy with carboplatin
boolean
C1514463 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
Prior Therapy Platinum-based Drug | Carboplatin Unit dose Reduced | Carboplatin Unit dose Discontinued | Toxicity aspects | intolerance to substance
Item
parts b and c: during prior platinum therapy, requirement for dose reduction or discontinuation of carboplatin for toxicity or lack of tolerability
boolean
C1514463 (UMLS CUI [1,1])
C2266918 (UMLS CUI [1,2])
C0079083 (UMLS CUI [2,1])
C0869039 (UMLS CUI [2,2])
C0392756 (UMLS CUI [2,3])
C0079083 (UMLS CUI [3,1])
C0869039 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C0040539 (UMLS CUI [4])
C1744706 (UMLS CUI [5])
Toxic effect Continuous Due to Prior Therapy | Alopecia | Mild Adverse Event
Item
ongoing toxic manifestations of previous treatments. exceptions to this are alopecia or certain grade 1 toxicities, which in the opinion of the investigator should not exclude the subject
boolean
C0600688 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
C0002170 (UMLS CUI [2])
C1513302 (UMLS CUI [3])
Thrombocytopenia 4 | Prior Chemotherapy
Item
a. any known history of grade 4 thrombocytopenia with any prior chemotherapy regimen
boolean
C2677608 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
Compression of spinal cord | Metastatic malignant neoplasm to brain | Steroids
Item
spinal cord compression or brain metastases unless asymptomatic, treated, stable, and not requiring steroids for at least 4 weeks before first dose of study drug
boolean
C0037926 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential | Contraceptive methods | Hysterectomy | Bilateral oophorectomy | Amenorrhea | Follicle stimulating hormone measurement | Postmenopausal state
Item
female subjects who are already pregnant or lactating, or plan to become pregnant within 6 months of the last dose of study drug are excluded. female subjects of childbearing potential must adhere to contraception guidelines. female subjects will be considered to be of nonchildbearing potential if they have undergone surgical hysterectomy or bilateral oophorectomy or have been amenorrheic for over 2 years with a screening serum follicle-stimulating hormone (fsh) level within the laboratory's reference range for postmenopausal females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
C0002453 (UMLS CUI [8])
C0202022 (UMLS CUI [9])
C0232970 (UMLS CUI [10])
Gender | Partner in relationship Childbearing Potential | Contraceptive methods
Item
male subjects with partners of childbearing potential must agree to adhere to contraception guidelines. men with pregnant or lactating partners or partners who plan to become pregnant during the study or within 6 months of the last dose of study drug are excluded.
boolean
C0079399 (UMLS CUI [1])
C0682323 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3])
major surgery | Investigational New Drugs | Major surgery Previous | Recovery Incomplete
Item
major surgery ≤4 weeks before first dose of study drug or incomplete recovery from a prior major surgical procedure
boolean
C0679637 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0679637 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C2004454 (UMLS CUI [4,1])
C0205257 (UMLS CUI [4,2])
Comorbidity Serious | Heart Diseases
Item
serious co-morbid medical conditions, including clinically-significant cardiac disease
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])