Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy
4. november 2020 opdateret af: Eli Lilly and Company
Phase 2 Trial Oral Enzastaurin in Prostate Cancer Patients Who Have Rising PSA (1) During Hormonal Manipulation and (2) After First-Line Cytotoxic Chemotherapy
The purpose is to see how quickly two different types of prostate cancer participants respond when taking enzastaurin.
Cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen (PSA)-progressive disease without clinical or radiographic evidence of metastatic disease.
Cohort 2 - participants with androgen-independent metastatic prostate cancer (documented bone or soft tissue metastases) with rising PSA, clinical, radiographic disease progression following one prior docetaxel-based regimen
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
73
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Stanford, California, Forenede Stater, 94305
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06520
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89135
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New York
-
Buffalo, New York, Forenede Stater, 14263
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
New York, New York, Forenede Stater, 10032
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Pennsylvania
-
Lancaster, Pennsylvania, Forenede Stater, 17605
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater, 38120
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- You are expected to be alive in the 12 weeks.
- You are at least 18 years old.
- You live close enough to the doctor's office to attend all of your required visits.
- You have not been treated with chemotherapy for your prostate cancer (cohort 1).
- Must have evidence of androgen-independent PSA-progressive disease without a history of or current (as judged by the investigator) clinical or radiographic evidence of metastatic disease with castrate levels of testosterone (<50 ng/dL) maintained by luteinizing hormone-releasing hormone (LHRH) agonist or bilateral orchiectomy following standard anti-androgen withdrawal. NOTE: PSA progression is defined as have rising PSA values of <=5 ng/mL (at least 3 measurements 1 week apart) with castrate levels of testosterone <50 ng/dL following appropriate antiandrogen withdrawal, without evidence of metastases. (cohort 1)
- No prior systemic chemotherapy for prostate cancer. No prior chemotherapy for any other indication within 2 years of study entry. NOTE: Participants previously treated with chemotherapy in the adjuvant/neoadjuvant setting were not be eligible. (cohort 1)
- You have had one prior docetaxel-based chemotherapy regimen (cohort 2).
- You have evidence of metastatic prostate cancer with bone or soft tissue disease (cohort 2).
- Must have evidence of docetaxel-resistant, androgen-independent metastatic prostate cancer with bone or soft tissue disease (PSA only participants are not eligible) defined as either: clinical, PSA or radiographic disease progression while receiving docetaxel-based therapy or PSA and/or radiographic progression at any time after completion of a docetaxel-containing regimen with PSA progression defined as a 25% increase in PSA from the post docetaxel value or interval progression in known metastatic sites of disease or development of new sites of disease on bone scan or computed tomography (CT) imaging. Note: Participants who discontinued a docetaxel-containing regimen due to toxicity or any other reasons not related to disease progression while on treatment, and were not able to complete at least 2 cycles, were not be eligible. (cohort 2)
- Your organs must be functioning properly.
Exclusion Criteria:
- You are unable to swallow pills.
- You have another illness besides your prostate cancer.
- You have taken another experimental drug within the last 30 days.
- You have a serious heart condition.
- You are receiving another anti-cancer therapy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Enzastaurin-Cohort 1
Chemo-naive participants who had androgen-independent prostate cancer with rising prostate-specific antigen (PSA) levels but no clinical or radiographic evidence of metastatic disease.
Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
|
Indgives oralt
Andre navne:
|
|
Eksperimentel: Enzastaurin-Cohort 2
Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent.
Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.
|
Indgives oralt
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cohort 1 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Tidsramme: Baseline to Measured Progressive Disease, Death, Unacceptable Toxicities, or Study Closure Whichever Occurred First (up to 56 weeks)
|
Objective responders were defined as participants (pts) in Cohort 1 who met prostate-specific antigen (PSA) response criteria.
PSA Complete response (CR) was defined as a decrease in PSA to an undetectable level (<0.2 ng/mL) confirmed by a second value obtained at least 4 weeks apart and without clinical or radiographic evidence of disease.
PSA Partial Response (PR) was defined as a decrease in PSA of >=50% at any time during the study.
The decline of >=50% in PSA must be from a baseline value of >5 ng/mL and must be confirmed by a second value obtained at least 4 weeks apart and without clinical or radiographic evidence of disease.
|
Baseline to Measured Progressive Disease, Death, Unacceptable Toxicities, or Study Closure Whichever Occurred First (up to 56 weeks)
|
|
Cohort 2 - Progression-free Survival (PFS)-Overall
Tidsramme: baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 weeks)
|
PFS was defined as the time from date of enrollment to first occurrence of (1) tumor progression (defined per Response Evaluation Criteria In Solid Tumors [RECIST]) for soft tissue lesions, and/or appearance of >=2 new lesions on bone scan (confirmed >=6 weeks later); (2) skeletal event (pathological bone fracture and/or need for palliative radiotherapy); (3) symptomatic progression (worsening of Eastern Cooperative Oncology Group (ECOG) performance status (PS) and/or weight loss >10% from baseline and/or increase in analgesic consumption and pain); or (4) Death due to any cause.
PFS was censored at date of last objective progression-free observation for participants who were still alive and had not progressed.
Participants who took any subsequent systemic anticancer therapy prior to progression or death were censored at date of last objective progression-free disease assessment prior to the date of the subsequent systemic anticancer therapy.
|
baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 weeks)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cohort 1 - Number of Participants With a 3-month PSA Level Decline of Greater Than or Equal to 30%
Tidsramme: baseline to 3 months
|
Number of participants exhibiting a PSA level decline from baseline of greater than or equal to 30% within the first 3 months of study.
|
baseline to 3 months
|
|
Cohort 1 - PSA Velocity
Tidsramme: baseline, 2 months and 3 months
|
PSA velocity is defined as the rate of change in the PSA level during the first 2 and 3 months of the study.
|
baseline, 2 months and 3 months
|
|
Cohort 1 - Progression-free Survival (PFS)-Overall
Tidsramme: baseline to date of disease progression, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)
|
Progression free survival (PFS) is defined as the time from the date of enrollment to the first occurrence of PSA progression or objective progression defined as development of radiographic evidence of metastatic disease irrespective of PSA value or death due to any cause.
PSA progression is defined as (a) for participants in whom a 50% decline in PSA has not been achieved, this is defined as 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 5 ng/mL that is confirmed by another value of PSA confirmed at least 4 weeks apart; (b) for participants in whom a 50% decline in PSA has been achieved, this is defined as 50% increase over the nadir and an increase in the absolute value of PSA level by 5 ng/mL that is confirmed by another PSA level at least 4 weeks apart.
|
baseline to date of disease progression, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)
|
|
Cohort 1 - Duration of Response
Tidsramme: time of response to progressive disease, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)
|
Duration of response was the date of first objective assessment of CR or PR to the date of first progression or death due to any cause.
Progression of disease defined as:1) PSA progression: (a) in whom a 50% decline in PSA has not been achieved, defined as 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 5 ng/mL and confirmed by another PSA at least 4 weeks apart, (b) in whom a 50% decline in PSA has been achieved, defined as 50% increase over the nadir and an increase in the absolute value of PSA level by 5 ng/mL and confirmed by another PSA level at least 4 weeks apart.
2) Objective Progression defined as radiographic evidence of metastatic disease irrespective of PSA value or 3) death due to any cause.
Duration of response was censored on the date of discontinuation or last assessment for those participants who were alive without progression.
|
time of response to progressive disease, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)
|
|
Cohort 2 - 3-month PSA Level Decline of Greater Than or Equal to 30%
Tidsramme: baseline to 3 months
|
Number of participants exhibiting a PSA level decline from baseline of greater than or equal to 30% within the first 3 months of study.
|
baseline to 3 months
|
|
Cohort 2 - PSA Velocity
Tidsramme: baseline, 2 months and 3 months
|
PSA velocity is defined as the rate of change in the PSA level during the first 2 and 3 months of the study.
|
baseline, 2 months and 3 months
|
|
Cohort 2 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Tidsramme: baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months)
|
Objective responders in Cohort 2 met either CR or PR for composite criteria of PSA and RECIST.
CR was defined as a decrease in PSA to an undetectable level (<0.2 ng/mL) confirmed by a second value at least 4 weeks apart and without clinical or radiographic evidence of disease per RECIST and normalization of bone scan.
Bone only disease CR is normalization of bone scan with achievement of a nondetectable PSA confirmed 4-weeks after initial undetectable PSA.
PR was defined as a decrease from baseline by 50% in PSA at any time during the study and confirmed by a second value at least 4 weeks apart and having at least a 30% decrease in sum of longest diameter of target lesions per RECIST and stable or improved bone scan.
|
baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months)
|
|
Cohort 2 - Percentage of Participants With Progression Free Survival (PFS) at 6 Months and 12 Months
Tidsramme: 6 months and 12 months
|
Percentage of participants who did not meet the following criteria at 6 months and at 12 months: disease progression defined per RECIST for soft tissue lesions and/or the appearance of 2 or more new lesions on bone scan, or skeletal event (any pathological bone fracture, and/or need for palliative radiotherapy), or symptomatic progression (worsening ECOG performance status) and/or weight loss >10% from baseline and/or increase in analgesic consumption and pain, or death due to any cause.
PFS was censored at the date of the most recent assessment for those who were still alive at the time of analysis and did not have evidence of tumor progression.
Participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the date of the subsequent systemic anticancer therapy.
Percent=(number of participants meeting PFS criteria/number of randomized)x100.
|
6 months and 12 months
|
|
Cohort 2 - Overall Survival
Tidsramme: baseline to date of death from any cause (up to 69.6 weeks)
|
Overall survival is the duration from enrollment to death.
For participants who were alive, overall survival was censored at the last contact.
|
baseline to date of death from any cause (up to 69.6 weeks)
|
|
Cohort 2 - Duration of Response
Tidsramme: time of response to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months)
|
Duration of response was the date of first objective assessment of CR or PR to the date of first progression or death due to any cause.
Progression of disease defined as:1) PSA progression: (a) in whom a 50% decline in PSA has not been achieved, defined as 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by 5 ng/mL and confirmed by another PSA at least 4 weeks apart, (b) in whom a 50% decline in PSA has been achieved, defined as 50% increase over the nadir and an increase in the absolute value of PSA level by 5 ng/mL and confirmed by another PSA level at least 4 weeks apart.
2) Objective Progression defined as radiographic evidence of metastatic disease irrespective of PSA value.
3) death due to any cause.
Duration of response was censored on the date of discontinuation or last assessment for those participants who were alive without progression.
|
time of response to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 months)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2007
Primær færdiggørelse (Faktiske)
1. juni 2009
Studieafslutning (Faktiske)
1. januar 2011
Datoer for studieregistrering
Først indsendt
26. januar 2007
Først indsendt, der opfyldte QC-kriterier
26. januar 2007
Først opslået (Skøn)
30. januar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10737 (DAIDS Protocol ID)
- H6Q-MC-S024 (Anden identifikator: Eli Lilly and Company)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .