Evidence map›Paper›PMID 36482193›Full record

Trial reportBritish journal of cancer2023

Efficacy and safety of rucaparib treatment in patients with BRCA-mutated, relapsed ovarian cancer: final results from Study 10.

Rebecca S Kristeleit, Yvette Drew, Amit M Oza, Susan M Domchek, Susana Banerjee, Rosalind M Glasspool, Judith Balmaña, Lee-May Chen, Manish R Patel, Howard A Burris and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01482715 (A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01482715 phase1 / phase2completednot on this map

A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor

TypeinterventionalSponsorpharmaand GmbHRan2011 to 2019Enrolled136ConditionsOvarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Advanced Solid Tumor With Evidence of Germline or Somatic BRCAArmsRucaparib
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 5 countries.

Rebecca S KristeleitUCL Cancer Institute, University College London, London, UK. Rebecca.kristeleit@gstt.nhs.uk.ORCID http://orcid.org/0000-0003-3825-1326
Yvette DrewNorthern Centre for Cancer Care, Newcastle Hospitals NHS Foundation and Newcastle University, Newcastle Upon Tyne, UK.
Amit M OzaDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Susan M DomchekDivision of Hematology Oncology, Abramson Cancer Center, Basser Center for BRCA, University of Pennsylvania, Philadelphia, PA, USA.
Susana BanerjeeGynaecology Unit, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK.ORCID http://orcid.org/0000-0002-8840-7934
Rosalind M GlasspoolBeatson West of Scotland Cancer Center, National Health Service Greater Glasgow and Clyde and University of Glasgow, Glasgow, UK.ORCID http://orcid.org/0000-0002-5000-1680
Judith BalmañaMedical Oncology, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Lee-May ChenDivision of Gynecologic Oncology, University of California, San Francisco, San Francisco, CA, USA.
Manish R PatelDrug Development Unit, Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA.
Howard A BurrisSarah Cannon Research Institute at Tennessee Oncology, Nashville, TN, USA.
Tamar SafraOncology Department, Sourasky Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Jennifer BorrowClinical Operations, Clovis Oncology, Inc., Boulder, CO, USA.
Kevin K LinMolecular Diagnostics, Clovis Oncology, Inc., Boulder, CO, USA.
Sandra GobleBiostatistics, Clovis Oncology, Inc., Boulder, CO, USA.
Lara MaloneyClinical Development, Clovis Oncology, Inc., Boulder, CO, USA.
Ronnie Shapira-FrommerDepartment of Oncology, Chaim Sheba Medical Center, Tel HaShomer, Israel.
Clovis Oncology (United States) · USSarah Cannon · USBC Cancer Agency · CAGuy's and St Thomas' NHS Foundation Trust · GBNational Health Service · GBRoyal Marsden NHS Foundation Trust · GBSheba Medical Center · ILTel Aviv University · ILUniversity Health Network · CAUniversity of California, San Francisco · USUniversity of Pennsylvania · USVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStudy 10, a four-part Phase 1/2 study, evaluated oral rucaparib monotherapy in patients with advanced solid tumours. Here we report the final efficacy and safety results in heavily pretreated patients with ovarian cancer who received rucaparib in Study 10 Parts 2A and 2B.

methodsParts 2A and 2B (Phase 2 portions) enrolled patients with relapsed, high-grade, platinum-sensitive or platinum-resistant, BRCA-mutated ovarian cancer who had received 2-4 (Part 2A) or 3-4 (Part 2B) prior chemotherapies. Patients received oral rucaparib 600 mg twice daily (starting dose). The primary endpoint was the investigator-assessed objective response rate (ORR) by RECIST v1.1.

resultsFifty-four patients were enrolled: 42 in Part 2A (all had platinum-sensitive disease) and 12 in Part 2B (4 with platinum-sensitive disease; 8 with platinum-resistant disease). ORR was 59.3% (95% CI 45.0-72.4%). The median time to onset of the most common nonhaematological treatment-emergent adverse events (TEAEs) was typically early (<56 days) and was later for haematological TEAEs (53-84 days). The median duration of grade ≥3 TEAEs was ≤13 days.

conclusionsIn patients with relapsed, platinum-sensitive or platinum-resistant germline BRCA-mutant high-grade ovarian cancer who had received ≥2 prior chemotherapies, rucaparib had robust antitumour activity with a safety profile consistent with prior reports. CLINICAL

trial registrationNCT01482715.

Indexed as

BRCA2 ProteinOvarian NeoplasmsCarcinoma, Ovarian EpithelialFemaleHumansIndolesNeoplasm Recurrence, LocalPlatinumPoly(ADP-ribose) Polymerase InhibitorsBRCA2 ProteinIndolesPlatinumPoly(ADP-ribose) Polymerase Inhibitorsrucaparib

Identifiers

PMID36482193
PMCPMC9902459
OpenAlexW4310962312

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.