Phase 2
N=38
Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01084655 ↗Enrolled (actual)
38
Serious AEs
70.3%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE) — 6; 8; 23; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAK-700 (Drug); Docetaxel (Drug); Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) or Serious Adverse Events (SAE) |
6; 8; 23; 5; 5; 16 | — |
| PRIMARY Number of Participants With TEAEs Related to Hematology and Serum Chemistry |
3; 4; 8; 2; 0; 6 | — |
| PRIMARY Number of Participants With TEAEs Related to Vital Signs |
3; 2; 1; 1; 0; 1 | — |
| PRIMARY Number of Participants With TEAEs Related to Electrocardiogram (ECG) |
1; 0; 1; 1; 0; 1 | — |
| PRIMARY Phase 2: Cmax: Maximum Observed Plasma Concentration for Docetaxel |
1330; 1600 | — |
| PRIMARY Phase 2: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Docetaxel |
1180; 1270 | — |
| PRIMARY Phase 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Docetaxel |
— | — |
| PRIMARY Phase 2: Terminal Phase Elimination Half-life (T1/2) for Docetaxel |
— | — |
| PRIMARY Phase 2: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for Orteronel |
2660; 3000 | — |
| PRIMARY Phase 2: AUC 0-tau: Area Under the Plasma Concentration Versus Time Curve Zero to the Time of the End of the Dosing Interval for Orteronel |
18000; 871 | — |
| PRIMARY Phase 2: Percentage of Participants With Prostate-specific Antigen (PSA) Response of 30 Percent (%), 50%, and 90% |
68; 59; 23 | — |
| PRIMARY Phase 2: Best PSA Response |
-61.72 | — |
| SECONDARY Phase 2: Time to PSA Progression |
203 | — |
| SECONDARY Phase 2: Time to Radiographic Disease Progression |
393 | — |
| SECONDARY Phase 2: Percentage of Participants With Objective Measurable Disease Response |
0; 70; 30; 0 | — |
| SECONDARY Phase 2: Change From Baseline in Circulating Tumor Cells (CTCs) |
47.9; -11.9; -39.0; -25.5; -11.3; -18.8 | — |
Summary
This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and will allow estimation of prostate-specific antigen (PSA) response in men with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility Criteria
Inclusion Criteria
Each patient must meet all of the following inclusion criteria:
- Voluntary written consent
- Male patients 18 years or older
- Estimated life expectancy of 6 months or more
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
- Radiograph-documented metastatic disease
- Progressive disease
- Prior surgical castration or concurrent use of an agent for medical castration
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Physical examination findings that are consistent with other study entry or exclusion criteria and identified but not excluded chronic conditions
- Even if surgically sterilized, patients must Practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug, OR Abstain from heterosexual intercourse
- Any use of opiates must be stable for at least 2 weeks prior to study entry
- Meet screening laboratory values as specified in protocol
- Suitable venous access
Exclusion Criteria
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Known hypersensitivity to TAK-700, docetaxel, prednisone or related compounds
- Received any of the following within 30 days prior to the first dose of TAK-700: prior therapy with any investigational compound; prior herbal product known to decrease PSA; OR radiation therapy for prostate cancer
- Received prior therapy with TAK-700, aminoglutethimide, ketoconazole or abiraterone (for Phase 1 only, patients previously treated with ketoconazole or abiraterone will be eligible if treatment with ketoconazole or abiraterone was discontinued at least 30 days prior to enrollment)
- Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug
- Received prior chemotherapy for prostate cancer
- Current spinal cord compression, bilateral hydronephrosis or neck outlet obstruction
- Symptoms that investigator deems related to prostate cancer
- Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
- Uncontrolled cardiovascular condition
- New York Heart Association Class (NYHA) Class III or IV
- Uncontrolled hypertension despite medical therapy
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- Unwilling or unable to comply with protocol
- Major surgery or serious infection within 14 days of first dose of TAK-700
- Life-threatening illness unrelated to cancer
- Uncontrolled nausea, vomiting or diarrhea
- Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700
Data sourced from ClinicalTrials.gov (NCT01084655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.