A Phase 2 interventional study of Rucaparib in Bladder Cancer, Urothelial Carcinoma and Metastatic Urothelial Carcinoma, sponsored by pharmaand GmbH. Terminated at 64 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-09.
Sponsored by pharmaand GmbH · Phase 2, Interventional, and Treatment
Among 881 studies in Urinary Bladder Neoplasms with a site in United States — 162 open to participants now, 267 under way, 31 of them phase 3. Urinary Bladder Neoplasms · United States.
Among the 881 studies in Urinary Bladder Neoplasms with a site in United States, this one is the 218th largest by enrollment of the 714 interventional ones that give a count, is one of 48 that started in 2018, is one of 237 in phase 2, and was the 473rd registered.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
Browse Urinary Bladder Neoplasms studies →162 of the 881 studies in Urinary Bladder Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
SystImmune Inc. · Sites in United States
Fred Hutchinson Cancer Center · Sites in United States
Fox Chase Cancer Center · Sites in United States
Dana-Farber Cancer Institute · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
881 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 281 · Phase 2 329 · Phase 3 88 · Phase 4 7
First in 1988; this study’s year is marked. 48 started in 2018.
This study's enrollment of 97 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Median enrollment 46 across the 714 interventional studies, 180 across the 144 observational. Of the 562 that completed or were terminated, 253 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
313 of 881 have an industry lead sponsor. The 10 most frequent:
pharmaand GmbH is the lead sponsor of 22 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
pharmaand GmbH has 2 studies filed under Urinary Bladder Neoplasms — fewer than ten, so there is no comparison to draw.
97 of the studies in Urinary Bladder Neoplasms with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06111235Phase 3CG Oncology, Inc.A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT | 2026-11 |
| NCT04658862Phase 3Janssen Research & Development, LLCA Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder | 2026-12-30 |
| NCT06525571Phase 3Johns Hopkins UniversityOutcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection | 2027-01-04 |
| NCT05911295Phase 3Seagen, a wholly owned subsidiary of PfizerDisitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | 2027-01-29 |
| NCT04241185Phase 3Merck Sharp & Dohme LLCEfficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) | 2027-01-31 |
Among the 881 studies in Urinary Bladder Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral rucaparib (monotherapy)
Drug: Rucaparib
Rucaparib will be administered daily.
Also known as: CO-338
Objective Response Rate (ORR) Per RECIST Version 1.1
ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Time frame: Time from first dose to date of progression, up to approximately 19 months
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
Time frame: Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
Overall Survival
Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).
Time frame: The total study time for reporting of deaths was approximately 19 months.
Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.
Time frame: From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
97 subjects were recruited from 40 sites across 6 countries.
| Milestone | HRD Unknown | HRD Negative | HRD Positive |
|---|---|---|---|
| Started | 47 | 30 | 20 |
| Completed | 47 | 30 | 20 |
| Not completed | 0 | 0 | 0 |
ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
| Participants | HRD Unknown | HRD Negative | HRD Positive | Overall |
|---|---|---|---|---|
| Objective Response Rate (ORR) Per RECIST Version 1.1 | 0 | 0 | 0 | 0 |
PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
| months | HRD Unknown | HRD Negative | HRD Positive | Overall |
|---|---|---|---|---|
| Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator | 1.8 (1.6 to 2.0) | 1.8 (1.5 to 2.0) | 1.4 (1.2 to 3.6) | 1.8 (1.6 to 1.9) |
Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).
| Participants | HRD Unknown | HRD Negative | HRD Positive | Overall |
|---|---|---|---|---|
| Overall Survival | 15 | 15 | 9 | 39 |
Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.
| ng/mL | HRD Unknown | HRD Negative | HRD Positive | Overall |
|---|---|---|---|---|
| Cycle 2 Day 1 | 2354.03 ± 2173.055 | 1927.77 ± 1352.707 | 1853.84 ± 1533.622 | 2129.70 ± 1831.099 |
| Cycle 3 Day 1 | 2037.90 ± 1253.715 | 1331.17 ± 357.010 | 643.00 ± 688.722 | 1647.33 ± 1068.270 |
| Cycle 4 Day 1 | 2225.00 ± 763.348 | 2058.00 ± 705.280 | 1585.00 ± 487.904 | 2032.73 ± 672.891 |
Collected over Adverse events for each patient were reported from the first dose until 28 days after last dose of study drug, and the total study time for adverse event reporting was approximately 19 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HRD Unknown | 9/47 (19.1%) | 20/47 (42.6%) | 45/47 (95.7%) |
| HRD Negative | 8/30 (26.7%) | 14/30 (46.7%) | 29/30 (96.7%) |
| HRD Positive | 7/20 (35%) | 11/20 (55%) | 19/20 (95%) |
| Overall | 24/97 (24.7%) | 45/97 (46.4%) | 93/97 (95.9%) |
| Event | HRD Unknown | HRD Negative | HRD Positive | Overall |
|---|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 6/47 | 9/30 | 3/20 | 18/97 |
| AnaemiaBlood and lymphatic system disorders | 1/47 | 1/30 | 3/20 | 5/97 |
| Cardiac arrestCardiac disorders | 0/47 | 0/30 | 1/20 | 1/97 |
| Intestinal obstructionGastrointestinal disorders | 0/47 | 0/30 | 1/20 | 1/97 |
| General physical health deteriorationGeneral disorders | 0/47 | 0/30 | 1/20 | 1/97 |
| PyrexiaGeneral disorders | 0/47 | 0/30 | 1/20 | 1/97 |
| HyponatraemiaMetabolism and nutrition disorders | 0/47 | 0/30 | 1/20 | 1/97 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/47 | 0/30 | 1/20 | 1/97 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/47 | 0/30 | 1/20 | 1/97 |
| HypotensionVascular disorders | 0/47 | 0/30 | 1/20 | 1/97 |
| Event | HRD Unknown | HRD Negative | HRD Positive | Overall |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 26/47 | 9/30 | 6/20 | 41/97 |
| FatigueGeneral disorders | 21/47 | 12/30 | 7/20 | 40/97 |
| AnaemiaBlood and lymphatic system disorders | 16/47 | 10/30 | 8/20 | 34/97 |
| Blood creatinine increasedInvestigations | 6/47 | 11/30 | 4/20 | 21/97 |
| Decreased appetiteMetabolism and nutrition disorders | 14/47 | 7/30 | 7/20 | 28/97 |
| VomitingGastrointestinal disorders | 13/47 | 6/30 | 3/20 | 22/97 |
| AstheniaGeneral disorders | 12/47 | 4/30 | 1/20 | 17/97 |
| ConstipationGastrointestinal disorders | 10/47 | 5/30 | 5/20 | 20/97 |
| Aspartate aminotransferase increasedInvestigations | 5/47 | 5/30 | 5/20 | 15/97 |
| Weight decreasedInvestigations | 6/47 | 7/30 | 0/20 | 13/97 |
| Age, Continuous(years) | HRD Unknown | HRD Negative | HRD Positive | Total |
|---|---|---|---|---|
| Median | 66.0 (50 to 85) | 66.0 (47 to 85) | 71.0 (39 to 87) | 66.0 (39 to 87) |
| Sex: Female, Male(Participants) | HRD Unknown | HRD Negative | HRD Positive | Total |
|---|---|---|---|---|
| Female | 9 | 3 | 9 | 21 |
| Male | 38 | 27 | 11 | 76 |
| Ethnicity (NIH/OMB)(Participants) | HRD Unknown | HRD Negative | HRD Positive | Total |
|---|---|---|---|---|
| Hispanic or Latino | 7 | 4 | 1 | 12 |
| Not Hispanic or Latino | 29 | 23 | 17 | 69 |
| Unknown or Not Reported | 11 | 3 | 2 | 16 |
| Race (NIH/OMB)(Participants) | HRD Unknown | HRD Negative | HRD Positive | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 1 | 2 | 0 | 3 |
| White | 32 | 24 | 18 | 74 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 12 | 3 | 2 | 17 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in Dec 2019, 18 months.
Results were first posted in Oct 2020, 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rucaparib