[c09aa8]: / clusters / 9knumclustersv2 / clust_1961.txt

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Prior chemotherapy for castration resistant disease; chemotherapy given in the castration-sensitive setting is permissible if stopped at least weeks prior to treatment start
Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by RECIST ..
Prior chemotherapy for castration resistant disease; chemotherapy given in the castration-sensitive setting is permissible; at least months from registration must have elapsed since chemotherapy was last received
Any prior chemotherapy for castration-resistant disease is not allowed. Previous and/or concurrent treatment with other anti-cancer treatments is permitted. Patients are allowed to be treated with chemotherapy during the duration of the trial. Patients who have received chemotherapy as part of initial androgen deprivation therapy for metastatic castration sensitive disease are eligible.
Prior chemotherapy for metastatic castration-resistant prostate cancer; chemotherapy administered in the castration-sensitive setting is allowed provided last dose of chemotherapy was greater than months prior to study entry
Patients must have a known diagnosis of either metastatic castration-resistant prostate cancer (mCRPC) or non-small cell lung cancer (NSCLC) with evidence of measurable disease.
Treatment with abiraterone acetate for castration-resistant prostate cancer (CRPC) in the past is required; it does not need to be the last treatment prior to enrollment
Prior treatment with docetaxel or cabazitaxel for metastatic castration-resistant prostate cancer is prohibited
Any therapy including chemotherapy (e.g., docetaxel) or biological therapy (e.g., vaccine, immunotherapy) for the treatment of castration-resistant prostate cancer. Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens, bicalutamide, nilutamide, or -? reductase inhibitor is permitted.
Experienced disease progression after having received at least but no more than prior next-generation androgen receptor-targeted therapies, and prior taxane-based chemotherapy, for castration-resistant disease
Patients must be castrate-resistant (i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy). Patients receiving medical castration therapy with gonadotropin-releasing hormone analogues should continue this treatment during this study.
Have minimally symptomatic metastatic castration recurrent prostate cancer with bone lesions; this patient population is defined as having failed hormone treatment and has insurance approval for PROVENGE therapy
Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within weeks of last treatment with docetaxel
Patients must have progressive metastatic castration-resistant prostate cancer (mCRPC). There must be radiographic evidence of disease progression or biochemically (rising PSA levels on successive measurements) recurring disease despite adequate testosterone suppression.
Prior surgical castration
Patients who have had chemotherapy for metastatic castration-resistant prostate cancer within the past year (patients who have had docetaxel for metastatic castration sensitive per CHAARTED data may enroll as long as they did not have progressive disease while on docetaxel and are months removed from treatment, with all treatment related toxicities resolving to at least grade )
For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), castration-resistant prostate cancer (CRPC) and pancreatic ductal adenocarcinoma (PDAC)
Histologically confirmed prostate adenocarcinoma without significant small- cell/neuroendocrine or other variant histologies, with rising PSA and/or radiographic progression in the setting of castration-level testosterone (< ng/dL) indicating mCRPC. Patients must have either undergone surgical castration or continue on GnRH agonist/antagonist on the appropriate schedule throughout the study period.
Does not have castration resistant disease\r\n* Castration resistance defined as progression of disease despite serum testosterone level of < ng/dL
History of prior chemotherapy (chemotherapy allowed for lead-in cohort in castration resistant disease)
Any prior treatment for castration-resistant prostate cancer (CRPC) with carboplatin, cisplatin, cabazitaxel or olaparib.
DISEASE SPECIFIC EXPANSION COHORTS: Prostate cancers patients enrolled on this study must have:\r\n* Metastatic or advanced (incurable and unresectable) castration resistant metastatic cancer\r\n* Received at least one additional line of anti-androgen therapy with abiraterone or enzalutamide\r\n* Measurable disease is not required for enrollment
Subjects must have measurable disease (RECIST v .) or patients may have bone metastatic disease evaluable by Prostate Cancer Working Group (PCWG) for subjects with metastatic castration-resistant prostate cancer (CRPC) or according to tumor evaluation criteria best suitable and accepted for the tumor type evaluated.
Chemotherapy resistant disease
History of surgical castration.
Subjects must be castration resistant with evidence of progressive prostate cancer despite castrate levels of testosterone (=< ng/dL) according to the PCWG criteria
Prior treatment with chemotherapy (docetaxel or cabazitaxel) for castration resistant prostate cancer
Have had prior chemotherapy for metastatic disease in castration-resistant prostate cancer (prior chemotherapy for hormone-sensitive disease, more than six months prior to registration, is acceptable)
Asymptomatic or minimally symptomatic (not requiring opioids for cancer related pain) metastatic castration-resistant prostate cancer (CRPC) patients on abiraterone as standard of care and achieved at least % decline of their pre-treatment PSA
Prior treatment with docetaxel or cabazitaxel for metastatic castration-resistant prostate cancer is prohibited
Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group [PCWG] criteria) and a castrate serum testosterone level (i.e., ? mg/dL)
Men with metastatic, castration resistant prostate cancer involving the bone, which is symptomatic or asymptomatic
Castration-resistant prostate cancer requires the following criteria:\r\n* Progression after surgical castration or on gonadotrophin releasing hormone (GnRH) agonist or antagonist\r\n* A castrate level of testosterone (< ng/dL)\r\n* Prostate cancer progression documented by PSA rise or bone progression according to Prostate Cancer Clinical Trials Working Group (PCWG)
Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC)
Prior chemotherapy for castration resistant prostate cancer; neoadjuvant chemotherapy and chemotherapy given for hormone sensitive prostate cancer are allowed
Castration levels of testosterone defined as =< ng/dL at study enrollment; must be at least months from surgical castration or must have received medical castration therapy for at least months and be receiving such therapy at the time of confirmed disease progression
Patients with chemotherapy resistant disease
Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
Patients must have progressive, metastatic, castration-resistant prostate cancer (mCRPC) as defined below:
Have progressive metastatic castration resistant prostate cancer, on androgen deprivation therapy, based on as least one of the following criteria:
Patients who have received more than prior non-docetaxel containing cytotoxic chemotherapy regimens for Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Have a history of traumatic or surgical castration
Experienced disease progression after having received prior next generation androgen receptor-targeted therapy for castration-resistant disease
Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
Castration-resistant prostate cancer (CRPC)
Patients who have received prior cytotoxic chemotherapy for castration-resistant prostate cancer unless enrolled in a previous chemotherapy cohort.
Has had chemotherapy for castration-resistant disease; chemotherapy for castration-sensitive disease is permitted
Castration-resistant prostate cancer: patients must have surgical or ongoing chemical (androgen deprivation therapy) castration, with baseline testosterone level =< ng/dL determined within weeks of starting study drug
Known castration-resistant disease
Castration-resistant disease defined as:
Men with metastatic castration-resistant prostate cancer
Vasectomy or surgical castration at least months prior to Screening.
Candidate for abiraterone therapy with documented evidence of metastatic castration-resistant prostate cancer. Metastatic status is defined as at least one documented metastatic lesion on either bone scan or CT/MRI scan. Castration resistant prostate cancer is defined as rising PSA or other signs of disease progression despite treatment with androgen deprivation therapy and the presence of a castrate level of testosterone (? ng/dL).
Prior cytotoxic chemotherapy or biologic therapy for the treatment of castration-resistant prostate cancer (CRPC)
Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer
Participants must have progressive disease despite ongoing androgen deprivation therapy (ADT) and castrate levels of testosterone, defined as castration resistant prostate cancer (CRPC)
Patients who have had chemotherapy for metastatic castration-resistant prostate cancer; (patients who have had docetaxel for metastatic castration sensitive disease per ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer [CHAARTED] Data may enroll as long as they did not have progressive disease while on docetaxel and are months removed from treatment, will all treatment related toxicities resolving to at least grade )
The subject has received chemotherapy for castration-resistant prostate cancer
Evidence of castration resistance defined as disease progression despite a testosterone level < ng/dL (or surgical castration)
Metastatic asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC) patients who are eligible for sipuleucel-T
Men with metastatic castration-resistant prostate cancer (mCRPC), with accessible metastatic soft-tissue lesions for tumor biopsy
The subject must currently have castration resistant prostate cancer defined as serial rising prostate-specific antigens (PSAs) with a castrate level of testosterone (< ng/dL)
A subject with non-metastatic castration-resistant prostate cancer (CRPC) may not have received prior chemotherapy unless in the neoadjuvant or adjuvant setting > months ago and may not have received prior zoledronic acid or denosumab
Prior cytotoxic chemotherapy, immunotherapy, a PIK/AKT/mTOR agent (including TORC and TORC inhibitors), or RA dichloride for the treatment of castration resistant prostate cancer (CRPC). Participants may have received docetaxel in the hormone-sensitive setting.
Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ? weeks prior to screening
Patient must have evidence of castration resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group [PCWG] criteria) and a castrate serum testosterone level (i.e. =< mg/dL)
Men with metastatic prostate cancer that require castration therapy with either using an luteinizing hormone-releasing hormone (LHRH) analogue or surgical castration are eligible; complete androgen blockade using anti-androgen therapy prior to castration or up to approximately - weeks following castration therapy is permitted to prevent disease flare; thereafter anti-androgen therapy may continue or be discontinued based on treating physicians preference; or\r\n* Any men with prostate cancer who are candidates for castration therapy despite no evidence of definite metastatic disease including patient with biochemical failure or rising PSA are also permitted to enter study provided castration therapy is planned for a minimum of a year; patients with biochemical failure prior to enrollment should have also have already received appropriate salvage therapy; men with prostate cancer who have already started castration therapy are also permitted to enter study provided castration therapy was initiated within one month of study entry; or\r\n* Men with prostate cancer previously treated with castration therapy for management of localized prostate cancer in the adjuvant setting or in combination with radiation therapy are permitted to enter study provided they currently have known metastatic disease and have non-castrate testosterone levels (testosterone > ng/dL)
Up to patients with castration-resistant prostate cancer (CRPC) that was pathologically confirmed as adenocarcinoma of the prostate and with evidence of metastatic disease on bone scan or other imaging. Patient must have progressive disease after at least one hormonal treatment and one cytotoxic therapy e.g. with docetaxel, mitoxantrone.
Patients who have had chemotherapy for metastatic castration-resistant prostate cancer
Metastatic castration-resistant prostate cancer (CRPC)
Patient must have evidence of castration resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group [PCWG] criteria) and a castrate serum testosterone level (i.e. =< mg/dL); if a subject also received an anti-androgen, he must first progress through antiandrogen withdrawal prior to being eligible; the minimum timeframe to document failure of anti-androgen withdrawal will be four weeks
Patients must have received at least one of the approved products known to improve the overall survival of patients with metastatic castration resistant prostate cancer (i.e. abiraterone, enzalutamide, sipuleucel-t, radium-, docetaxel or cabazitaxel)
Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)
Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ? weeks prior to screening
Have metastatic castration-resistant prostate cancer (prostate cancer progressing despite castrate levels of testosterone [< ng/dL] using standard measures of progression defined by Prostate Cancer Working Group ), are chemo-naive for metastatic castration-resistant prostate cancer (mCRPC); patients must have symptomatic disease or visceral metastases or otherwise be eligible for docetaxel treatment per investigator judgment (e.g. for progression on imaging or rapidly rising PSA despite nd line hormonal treatment);\r\n* Note: Six cycles of prior docetaxel are allowed in hormone-sensitive disease, per Eastern Cooperative Oncology Group (ECOG) data and have been off of docetaxel for at least months
Have had prior chemotherapy for metastatic disease in castration-resistant prostate cancer (prior chemotherapy for hormone-sensitive disease, more than twelve months prior to registration, is acceptable)
Castration-resistant prostate cancer
Patients with metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
Castration-resistant disease according to PCWG criteria
- Castration-resistant disease as defined by PCWG criteria
Patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
At the time of enrollment, patients must demonstrate evidence of castration-resistant prostate cancer with a documented castrate level of serum total testosterone (< ng/dL) while on continuous androgen deprivation therapy
Castration-resistant PCa