Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer

NCT02057666 | Terminated Phase 3 Results DMC

• 1 other identifier: 8-55-58102-003
• Study Type: interventional
• Target: 146
• Locations: 3 countries
• Sites: 36

Brief Summary

The primary objective was to confirm the effect of tasquinimod in delaying disease progression or death as compared with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer (mCRPC). Secondary objectives included further evaluation of the safety profile of tasquinimod, comparison of clinical benefits (such as overall survival and symptoms) of tasquinimod with placebo, to evaluate the quality of life impact and to determine the pharmacokinetics of tasquinimod.

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

CRPC; Metastatic; Chemotherapy naïve; Chemo-naïve; Prostate cancer; mCRPC; Chemotherapy-naïve; Chemo naïve

Outcome Measures

Primary Outcomes (1)

• Time to Radiological Progression-Free Survival (PFS)

  PFS was defined as the time from the date of randomisation to the date of radiological progression (confirmed by the central imaging assessment) or death due to any cause. Radiological progression was defined by any of the following criteria: progression of soft tissue lesions evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 criteria; progression of bone lesions detected with bone scan according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria; or radiologically confirmed spinal cord compression or pathological fracture due to malignant progression. The primary endpoint was centrally and independently evaluated.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcomes (6)

• Overall Survival

  From randomisation up to 3 years

• Local Assessment of Radiological PFS

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

• Time to Symptomatic PFS Based on Local Assessment

  Every 3 months

• Time From Randomisation to Further Treatment for Prostate Cancer

  Every 6 months during the follow-up period

• Quality of Life (QoL)

  Every 3 months

Study Arms (2)

Tasquinimod

EXPERIMENTAL

One capsule (0.25, 0.50 or 1 mg), taken orally once a day with water and food (preferably the main evening meal).

Drug: Tasquinimod

Placebo

PLACEBO COMPARATOR

One capsule, taken orally once a day with water and food (preferably the main evening meal).

Drug: Placebo

Interventions

Tasquinimod DRUG

A patient initially received a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively.

Also known as: ABR-215050

Tasquinimod

Placebo DRUG

Placebo capsules were identical to tasquinimod capsules in appearance and excipients but excluded the active compound (tasquinimod).

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asian male aged at least 20 years at the time of signing the informed consent form.
• Histologically confirmed diagnosis of adenocarcinoma of the prostate.
• Evidence of metastatic disease (bone and/or visceral), excluding node lesion only, on radiographic examination, whether from bone scan (bone lesions) or other imaging modality (CT scan/MRI).
• Chemical or surgical castration verified by levels of serum testosterone ≤50 ng/dL (1.75 nmol/L).
• Evidence of progressive disease after castration levels of testosterone had been achieved, defined by any of the following criteria:
• Increasing serum Prostate Specific Antigen (PSA) levels, with the most recent value ≥2 ng/mL (increasing levels must have been confirmed by three consecutive PSA measurements, within 15 months prior to the start of study treatment. The time between each PSA test should have been preferably at least 14 days, however a minimum of 7 days was acceptable. The third value was used for study selection).
• Progression of soft tissue metastasis documented within 6 weeks prior to randomisation (CT scan or MRI).
• Progression of bone disease (at least one new bone lesion as measured by bone scan within the 12 weeks prior to the start of study treatment).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Laboratory values as follows:
• Haemoglobin ≥90 g/L (≥9 g/dL).
• Absolute neutrophil count ≥1500/μL.
• Platelets ≥100,000/μL.
• Serum creatinine ≤1.5 times the upper limit of normal (ULN).
• Total bilirubin ≤1.5 times ULN.

You may not qualify if:

• Cytotoxic chemotherapy for the treatment of prostate cancer within 2 years prior to the start of study treatment.
• Therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide e.g. Casodex®) prior to the start of study treatment.
• Concurrent use of other anticancer agents or treatments, with the exception of ongoing treatment with luteinising hormone-releasing hormone (LHRH) agonists or antagonists, denosumab (Prolia®) or bisphosphonate (e.g. zoledronic acid), which were allowed. Ongoing treatment was to be kept at a stable schedule; however, if medically required, a change of dose, compound, or both was allowed.
• Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
• Prostate cancer pain that required ongoing treatment with narcotic analgesics or warranted the initiation of radio- or chemotherapy.
• Both of the following criteria:
• Visceral metastasis.
• Bone lesions both on and outside of the spinal axis.
• PSA \>100 ng/mL.
• Ongoing treatment with warfarin.
• Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.
• Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone was not allowed within 1 year prior to the start of study treatment.
• Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.
• Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.
• Simultaneous participation in any other study involving treatment with investigational drugs or having received treatment with investigational drugs less than 4 weeks prior to the start of study treatment.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (36)

Beijing Chao-Yang Hospital Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Friendship Hospital Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100370, China

Location

Beijing Hospital of Ministry of Health

Beijing, Beijing Municipality, 100730, China

Location

Southwest Hospital (the First Affiliated Hospital of Third Military Medical University PLA)

Chongqing, Chongqing Municipality, 400038, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Guangshou First People's Hospital

Guangzhou, Guangdong, 510180, China

Location

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Ruijin Hospital Shanghai Jiaotong University of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Huadong Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 61004, China

Location

Sichuan Academy of Sichuan Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

General Hospital Chengdu Military Region of PLA

Chengdu, Sichuan, 610083, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The First Affiliated Hospital College of Medicine Zhujiang University

Hangzhou, Zhejiang, 310003, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Chungbuk National University Hospital

Cheongju-si, Chungcheong Province, 361-711, South Korea

Location

Chonnam National University Hospital

Gwangju, 501-757, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Neoplasm Metastasis; Prostatic Neoplasms

Interventions

tasquinimod

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated early due to the Sponsor deciding to stop development in prostate cancer; therefore, the results of all efficacy analyses should be considered exploratory and not supportive of efficacy in any indication.

Results Point of Contact

• Title: Medical Director, Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Medical Director Uro-Oncology

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 7, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-03

Locations

TW (4); KR (5); CN (27)