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 : Active, not recruiting
First Posted : February 15, 2018
Last Update Posted : December 2, 2020
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 (Clinical Trial)|
|Actual Enrollment :||16 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 :||February 2022|
|Estimated Study Completion Date :||February 2022|
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
|Complexo Hospitalario Universitario de Santiago|
|Santiago De Compostela, A Coruña, Spain, 15706|
|Hospital Universitario Central de Asturias|
|Oviedo, Asturias, Spain, 33011|
|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|
|Hospital Clínic de Barcelona|
|Barcelona, Spain, 08036|
|Complejo Hospitalario Regional Reina Sofía|
|Córdoba, Spain, 14004|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Fundación Instituto Valenciano de Oncología|
|Valencia, Spain, 46009|
|Hospital Universitario i Politècnic La Fe|
|Valencia, Spain, 46026|
|Principal Investigator:||María J Juan Fita, MD||Fundación Instituto Valenciano de Oncología|