Cabazitaxel in mCRPC Patients With AR-V7 Positive CTCs (CARVE)
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|ClinicalTrials.gov Identifier: NCT02621190|
Recruitment Status : Withdrawn (no approval)
First Posted : December 3, 2015
Last Update Posted : August 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: cabazitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-randomized Phase 2 Open-label Multicenter Study Determining the Response to Cabazitaxel in Metastatic Prostate Cancer (mCRPC) Patients With AR-V7 Positive Circulating Tumor Cells (CTCs): CARVE|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||June 2019|
No Intervention: A
patients without CTCs or AR-V7 negative CTCs are treated according to their physician's discretion
patients with AR-V7 positive CTCs are treated with cabazitaxel 25mg/m2 q3w
Other Name: Jevtana
- Prostate specific antigen (PSA) response rate [ Time Frame: 12 weeks after start of treatment ]PSA response rate is defined as a reduction of at least 50% from baseline during therapy, confirmed after ≥4 weeks by an additional PSA evaluation.
- Circulating tumor cell (CTC) response rate [ Time Frame: 9 weeks after start of treatment ]CTC Response rate is defined as a decrease from ≥5 CTCs per 7.5 mL blood at baseline to <5 CTCs per 7.5 mL blood, as measured by the CellSearch system
- Prostate specific antigen (PSA) change from baseline [ Time Frame: 12 weeks after start of treatment ]• PSA change from baseline at 12 weeks defined as the percent change in PSA from baseline (rise or fall) at 12 weeks, according to PCWG2 criteria.
- Maximum Prostate specific antigen (PSA) decrease [ Time Frame: through study completion, an average of two years ]Maximum PSA decrease is defined according to PCWG2 criteria (30), i.e., the maximal change (rise or fall) at any time through study completion, illustrated by a waterfall plot
- Progression-free survival [ Time Frame: from date of treatment allocation until the date of first documented progression (see description) or date of death from any cause, whichever came first, assessed through study completion, up to 100 months ]
Progression defined as:
- At least 2 consecutive PSA rises over a reference value, with an interval of ≥ 1 week between each determination. PSA at screening visit should be ≥ 2.0 μg/l; the date of progression will be the first of the 2 consecutive dates.
- Soft tissue disease progression defined by modified RECIST criteria (1.1) (baseline LN size must be ≥ 2.0 cm to be considered target or evaluable lesion).
- Bone disease progression defined by the appearance of new lesions on a bone scan, confirmed on a second bone scan ≥ 6 weeks later. Ambiguous results should be confirmed by other imaging modalities (e.g., CT or MRI). The date of progression will be the first of the 2 consecutive dates.
- Overall survival [ Time Frame: time from treatment group allocation to death due to any cause, assessed through study completion, up to 100 months ]
- grade 3-4 adverse events and serious adverse events (SAEs) [ Time Frame: through study treatment until 30 days after end of treatment ]
- Cabazitaxel concentration in the blood (measured in ng/mL) [ Time Frame: during the first cycle of cabazitaxel, until 6 hours after end of cabazitaxel infusion ]
- Total systemic exposure to cabazitaxel (measured in mg/m2) [ Time Frame: through study treatment, an average of 10 cycles, i.e., 30 weeks of treatment ]
- AR-V7 mRNA expression as well as mRNA expression of other splice variants in CTCs indicated as absent (─) or present (+) on a per-patient basis [ Time Frame: at screening visit ]
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): NCT02621190
|Erasmus MC Cancer Institute|
|Rotterdam, Netherlands, 3075 EA|