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Solid TumorPhase 2LODESTARNCT04171700

A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes

A Phase 2 study testing Rucaparib in people with Solid Tumor, run by pharmaand GmbH at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
Rucaparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
19 sitesUnited States
Study dates
16 Jan 2020to 15 Jul 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Unresectable, locally advanced or metastatic solid tumor and relapsed/progressive disease
  • Measurable disease per RECIST v1.1 or modified RECIST v1.1 and PCWG3 (for prostate cancer)
  • Have a deleterious mutation (germline or somatic) in BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B. Note: Breast cancer patients that are HER2 negative and have germline BRCA1 or BRCA2 mutations AND patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or metastatic castration-resistant prostate cancer with BRCA1 or BRCA2 mutations are ineligible for this trial.
  • At least one prior line of therapy extending overall survival or standard of care therapy for advanced disease. Note: Some tumor types have specific inclusion/exclusion criteria for previous treatments.
  • ECOG 0 or 1
  • Tumor tissue available for genomic analysis, or must be willing to have a biopsy if no archival tumor tissue available
  • Adequate organ function
  • Life expectancy of 4 months

Who cannot join

  • Active central nervous system brain metastases, leptomeningeal disease or primary tumor of CNS origin
  • Active second malignancy (Exceptions: Successfully treated malignancy with no active disease for 1 year, surgically cured and/or low-risk tumors, or patients receiving ongoing anticancer hormonal therapy for a previously treated cancer)
  • Pre-existing gastrointestinal disorders/conditions interfering with ingestion/absorption of rucaparib
  • Prior treatment with a PARP inhibitor
  • More than 3 prior lines of chemotherapy in the locally advanced/metastatic setting
  • History of myelodysplastic syndrome or acute myeloid leukemia

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Beth Israel Deaconess Medical Cancer Surgical Pavilion

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • SCRI/Tennessee Oncology - Chattanooga

    Chattanooga, Tennessee, 37404

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • Ohio State University

    Columbus, Ohio, 43210

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • UCLA Medicine Hematology and Oncology

    Los Angeles, California, 90024

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Stephenson Cancer Center - The University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • New York Cancer and Blood Specialists

    Port Jefferson Station, New York, 11776

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

  • Seattle Cancer Care Alliance/University of Washington

    Seattle, Washington, 98109

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • New York Cancer And Blood Specialists

    The Bronx, New York, 10469

Other trials in United States

About this study

Official title: A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes

A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.

Conditions
Solid Tumor
Being tested
Rucaparib
Keywords
rucaparib, PARPi, rare tumor, solid tumor, CO-338, ovarian cancer, prostate cancer, pancreatic cancer, breast cancer, lung cancer, colon cancer, gastric cancer, bladder cancer, colorectal cancer, PARP inhibitor, homologous recombination, DNA repair, LODESTAR, germline, somatic
Medical subject headings
Ovarian Neoplasms, Prostatic Neoplasms, Pancreatic Neoplasms, Breast Neoplasms, Lung Neoplasms, Colonic Neoplasms, Stomach Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RucaparibDrug

    Also called Rubraca, Rucaparib camsylate, Rucaparib tablets, CO-338

    Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).

Study groups in NCT04171700
Study groupRoleWhat they receive
RucaparibExperimentalEligible participants will be enrolled in either Cohort A or Cohort B. Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D. Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.
Receives: Drug: Rucaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Overall Response Rate by Investigator

    Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

Secondary outcomes (7)

  1. Overall Response Rate by Independent Radiology Review

    Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

  2. Duration of Response

    Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

  3. Disease Control Rate

    Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

  4. Progression-free Survival

    Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

  5. Overall Survival

    Measure of clinical benefit, defined as the duration from study enrollment to death.

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

  6. Number of Participants Experiencing Treatment-emergent Adverse Events

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

  7. Steady State Minimum Concentration [Cmin]

    Rucaparib pharmacokinetics

    Measured: From first dose of study drug until disease progression (up to approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start16 Jan 2020
  3. Primary completion8 Jun 2022
  4. Study completion15 Jul 2022

Why it stopped: The study was terminated due to a change in development priorities.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04171700
Sponsor's protocol ID
CO-338-100
Acronym
LODESTAR
Status last verified
Sep 2023
First submitted
19 Nov 2019
Last updated
2 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations. Data will be provided by Clovis Oncology.

Publications

  • Anbil S, Seewald NJ, Chiorean EG, Hussein M, Kasi PM, Laux DE, Schwartz GK, Shapiro GI, Lin KK, Craib M, Maloney L, McLachlan K, Tukachinsky H, Schrock AB, Wang S, Sokol ES, Decker B, Nathanson KL, Domchek SM, Reiss KA. LODESTAR: A Single-Arm Phase II Study of Rucaparib in Solid Tumors With Pathogenic Germline or Somatic Variants in Homologous Recombination Repair Genes. JCO Precis Oncol. 2025 Jul;9:e2500090. doi: 10.1200/PO-25-00090. Epub 2025 Jul 9.

    PubMed 40632975

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rucaparib in people with Solid Tumor, run by pharmaand GmbH at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response Rate by Investigator (time frame: From first dose of study drug until disease progression (up to approximately 2 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04171700, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

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LODESTAR Clinical Trial NCT04171700 | AzTrials