Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response (IMANOL) (IMANOL)
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|ClinicalTrials.gov Identifier: NCT03434158|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : February 7, 2019
A number of important systemic therapies have been developed to treat mCRPC and have received regulatory approval and now comprise the current therapeutic landscape. Durable and complete response following first-line chemotherapy in patients with advanced PC are uncommon. Most patients will ultimately experience disease progression within 6-9 months after initial response. Optimal Second line therapy in mCRPC is not well established and several options are possible.
Olaparib has demonstrated anti-tumour activity in non-comparative studies in patients with germline BReast CAncer gene (gBRCA) mutated cancers including ovarian, breast, pancreas and prostate. Olaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed Breast Cancer gene-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
This phase II study is developed to assess the effect of maintenance treatment with olaparib on radiologic progression free survival (rPFS) in patients with mCRPC who have received at least 6 cycles of docetaxel and achieved partial or complete response or disease stabilization according RECIST 1.1 criteria and PCWG3.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic||Drug: Olaparib||Phase 2|
|Study Type :||Interventional|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Evaluating Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response.|
|Actual Study Start Date :||February 6, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
300 mg twice a day
Other Name: Lynparza
- Radiographic progression free survival (rPFS) [ Time Frame: Up to 1 year ]Time from treatment with olaparib to the date of first disease radiographic progression or death for any reason. Radiographic progression disease will be evaluated according RECIST 1.1 criteria and PCWG3
- PSA progression free survival (PSA PFS) [ Time Frame: Up to 1 year ]Time from treatment with olaparib to the date of first PSA progression (according PWCG3 criteria) or death for any reason.
- Clinical PFS [ Time Frame: Up to 1 year ]Time from treatment with olaparib to the date of first clinical progression (significant pain increase or clinical deterioration that requires initiating another line of treatment) or death for any reason.
- Radiologic response rate [ Time Frame: Up to 1 year ]Radiographic response will be evaluated according RECIST 1.1.
- PSA response rate [ Time Frame: Up to 1 year ]PSA response is a reduction in serum PSA concentration of ≥50% from baseline.
- Number of individual events (hematologic events and not hematologic events) [ Time Frame: Up to 1 year ]Number of events per patient
- Gene mutation(s) [ Time Frame: At Baseline ]Number of gene mutation/s
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434158
|Contact: Macarena Cruz Navasfirstname.lastname@example.org|
|Complexo Hospitalario Universitario de Santiago||Recruiting|
|Santiago De Compostela, A Coruña, Spain, 15706|
|Contact: Urbano Anido, MD 0034981950511 email@example.com|
|Hospital Universitario Central de Asturias||Recruiting|
|Oviedo, Asturias, Spain, 33011|
|Contact: Carlos Álvarez, MD 0034985108000 firstname.lastname@example.org|
|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|
|Contact: Lucía Heras, MD 0034932607822 email@example.com|
|Hospital Clínic de Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Begoña Mellado, MD 0034932275400 ext 3297 firstname.lastname@example.org|
|Complejo Hospitalario Regional Reina Sofía||Recruiting|
|Córdoba, Spain, 14004|
|Contact: María J Méndez, MD 0034957011464 email@example.com|
|Hospital Universitario 12 de Octubre||Recruiting|
|Madrid, Spain, 28041|
|Contact: José M Sepulveda, MD 0034913908546 firstname.lastname@example.org|
|Fundación Instituto Valenciano de Oncología||Recruiting|
|Valencia, Spain, 46009|
|Contact: María J Juan Fita, MD 0034961104606 email@example.com|
|Hospital Universitario i Politècnic La Fe||Recruiting|
|Valencia, Spain, 46026|
|Contact: David Lorente, MD 0034961244000 firstname.lastname@example.org|
|Principal Investigator:||María J Juan Fita, MD||Fundación Instituto Valenciano de Oncología|