A Phase 2 interventional study of orteronel and laboratory biomarker analysis in Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer and Recurrent Prostate Cancer, sponsored by University of Southern California. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-31.
Sponsored by University of Southern California · Phase 2, Interventional, and Treatment
This phase II trial studies how well orteronel works in treating patients with metastatic hormone-resistant prostate cancer. Orteronel may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To assess the relationship between circulating tumor cell (CTC)-based androgen receptor (AR) expression level and >=-50% prostate-specific antigen (PSA) decline following 12 weeks of therapy with TAK-700 (orteronel).
SECONDARY OBJECTIVES:
I. To assess changes in PSA and CTC levels and time to PSA progression (best response, decline at 12 weeks as continuous variable, etc.) with or without prior docetaxel-based treatment.
II. To assess measurable disease response and time to radiographic disease progression for castration-resistant prostate cancer (CRPC) with or without prior docetaxel-based treatment.
III. To explore relationships between endocrine and clinical responses.
IV. To confirm the safety of TAK-700 administered without prednisone in patients with metastatic CRPC.
OUTLINE: Patients receive orteronel orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 4 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Progression requiring a change in oncologic therapy defined by any of the following:
Patients should have recovered from prior oncologic therapies to a Common Terminology Criteria (CTC) grade =\< 1 except stable neuropathy or alopecia at National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade =\< 2; if rapid clinical progression is documented by imaging, changes in PSA, or symptoms, then study treatment can begin >= 2 weeks from prior therapy; otherwise, the following time periods between prior anti-cancer therapies and study treatment day 1 will apply:
Exclusion Criteria:
Electrocardiogram (ECG) abnormalities of:
Patients receive orteronel 300 mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: orteronel · Other: laboratory biomarker analysis
Given PO
Also known as: TAK-700
Correlative studies
Androgen Receptor (AR) Protein Expression Levels in CTCs
The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of prostate-specific antigen (PSA) response.
Time frame: Up to 4 weeks
PSA Response, Defined as Occurrence of PSA Decline to Greater Than or Equal to 50% From Baseline
Standard descriptive methods will be used to summarize PSA. Values will be tabulated as outlined in the Prostate Cancer Working Group 2 (PCWG2) criteria and presented as Kaplan-Meier survival curves, as appropriate.
Time frame: At 12 weeks
Best PSA Response
Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
Time frame: Up to 24 weeks
Absolute Change in PSA
Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
Time frame: Baseline to 24 weeks
Overall Response Rate Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and PCWG2 Criteria
Response will be tabulated descriptively with 95% confidence intervals (CIs) and Kaplan-Meier survival curves, as appropriate.
Time frame: Up to 3 years
Duration of Response Using RECIST Version 1.1 and PCWG2 Criteria
Response will be tabulated descriptively with 95% CIs and Kaplan-Meier survival curves, as appropriate.
Time frame: Up to 3 years
Number of Participants With Grade 3 or Higher Toxicity
Summary of grade 3 (per Common Terminology Criteria for Adverse Events (CTCAE v4.0) or higher toxicities which generally is described as a severe reaction or symptom.
Time frame: 30 days
Participants were recruited at the University of Southern California (USC) medical clinics from December 2013 to February 2014. Due to results of two phase III clinical trials in metastatic, castration resistant prostate cancer (mCRPC), the sponsor determined that the drug has not demonstrated a clinical profile sufficient to move forward in mCRPC.
| Milestone | Treatment (Orteronel) |
|---|---|
| Started | 4 |
| Completed | 0 |
| Not completed | 4 |
| Withdrew: Lack of efficacy | 3 |
| Withdrew: Sponsor decision | 1 |
The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of prostate-specific antigen (PSA) response.
No measurements were reported for this outcome.
Standard descriptive methods will be used to summarize PSA. Values will be tabulated as outlined in the Prostate Cancer Working Group 2 (PCWG2) criteria and presented as Kaplan-Meier survival curves, as appropriate.
No measurements were reported for this outcome.
Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
No measurements were reported for this outcome.
Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.
No measurements were reported for this outcome.
Response will be tabulated descriptively with 95% confidence intervals (CIs) and Kaplan-Meier survival curves, as appropriate.
No measurements were reported for this outcome.
Response will be tabulated descriptively with 95% CIs and Kaplan-Meier survival curves, as appropriate.
No measurements were reported for this outcome.
Summary of grade 3 (per Common Terminology Criteria for Adverse Events (CTCAE v4.0) or higher toxicities which generally is described as a severe reaction or symptom.
| Participants | Treatment (Orteronel) |
|---|---|
| Number of Participants With Grade 3 or Higher Toxicity | 1 |
Collected over Days 1, 8, 15, 21 of each cycle and treatment end (30 days after last dose or start of new treatment).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Orteronel) | 0/4 (0%) | 1/4 (25%) | 3/4 (75%) |
| Event | Treatment (Orteronel) |
|---|---|
| Abdominal PainGastrointestinal disorders | 1/4 |
| AnemiaBlood and lymphatic system disorders | 1/4 |
| HypertensionVascular disorders | 1/4 |
| Platelet count decreasedInvestigations | 1/4 |
| Event | Treatment (Orteronel) |
|---|---|
| AnorexiaMetabolism and nutrition disorders | 3/4 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/4 |
| FatigueGeneral disorders | 3/4 |
| NauseaGastrointestinal disorders | 3/4 |
| Abodminal PainGastrointestinal disorders | 2/4 |
| Aspartate Aminotransferase increasedInvestigations | 2/4 |
| Back painMusculoskeletal and connective tissue disorders | 2/4 |
| ConstipationGastrointestinal disorders | 2/4 |
| FeverGeneral disorders | 2/4 |
| HyperglycemiaMetabolism and nutrition disorders | 2/4 |
| Age, Categorical(Participants) | Treatment (Orteronel) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Treatment (Orteronel) |
|---|---|
| Female | 0 |
| Male | 4 |
| Region of Enrollment(Participants) | Treatment (Orteronel) |
|---|---|
| United States | 4 |
This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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