Advanced Solid TumorPhase 1NCT03499444
A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
A Phase 1 study testing Rucaparib in people with Advanced Solid Tumor, run by pharmaand GmbH at 3 sites in Japan.
Trial summary
This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (BID) to Japanese patients with a solid tumor who have failed previous standard treatment for their cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Rucaparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesJapan
- Study dates
- 6 Feb 2018to 13 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 20 years of age at the time the informed consent form is signed and of Japanese ethnicity (ie, both parents are native Japanese and were born in Japan).
- Have a solid tumor that has progressed on standard treatment:
- For patients enrolled in the dose-escalation portion, has confirmed solid tumor that is locally recurrent or metastatic
- For patients enrolled in the dose-expansion portion, has high-grade serous ovarian cancer, or BRCA 1/2 mutated breast cancer, or other solid tumor with BRCA 1/2 or related gene mutation
- Have to have evaluable disease (i.e. disease can be followed on scans.)
- Be willing and able to fast for at least 14 hours
Who cannot join
- Active second malignancy
- Prior treatment with any PARP inhibitor
- Symptomatic and/or untreated CNS metastases
- Women who are breastfeeding or pregnant
- Pre-existing duodenal stent and/or any gastrointestinal disorder that would interfere with drug absorption
- Requires regular blood transfusions
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Division of Medical Oncology, Hyogo Cancer Center
Akashi, Hyōgo, 673-8558
Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center
Hidaka, Saitama, 350-1298
Department of Breast and Medical Oncology, National Cancer Center Hospital
Tsukiji, Tokyo, 104-0045
About this study
Official title: A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (BID) to Japanese patients with a solid tumor who have failed previous standard treatment for their cancer. A recommended dose of rucaparib for Japanese patients will be determined in a dose-escalation portion and then further evaluated in a dose-expansion portion of the study.
- Conditions
- Advanced Solid Tumor
- Being tested
- Rucaparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RucaparibDrug
Also called CO-338
Rucaparib will be administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| Oral Rucaparib monotherapy | Experimental | Part I: Dose Escalation, Part II: Dose Expansion (Additional patients will be enrolled at the recommended dose as defined in Part I of the study.) Receives: Drug: Rucaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability
Measured: From enrollment to completion of Part I (up to 12 months)
Number of participants with serious AEs as a measure of safety and tolerability
Measured: From enrollment to completion of Part I (up to 12 months)
Number of participants with worsening laboratory values as a measure of safety and tolerability
Measured: From enrollment to completion of Part I (up to 12 months)
Secondary outcomes (5)
Dose-limiting toxicities (DLTs) during Cycle 1 of treatment
Measured: From enrollment to completion of Part I (up to 12 months)
Area under the plasma concentration versus time curve [AUC]
Measured: From enrollment to completion of Part I (up to 12 months)
Peak Plasma Concentration [Cmax]
Measured: From enrollment to completion of Part I (up to 12 months)
Total Plasma Clearance [CI/F]
Measured: From enrollment to completion of Part I (up to 12 months)
Response to treatment according to RECIST Version 1.1
Measured: From enrollment to primary completion of study (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start6 Feb 2018
- Primary completion18 Jun 2019
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- pharmaand GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499444
- Sponsor's protocol ID
- CO-338-081
- Status last verified
- Jun 2023
- First submitted
- 26 Mar 2018
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
- ClinicalTrials.gov ID
- NCT03499444
- Acronym / sponsor ID
- CO-338-081
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- pharmaand GmbHIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (BID) to Japanese patients with a solid tumor who have failed previous standard treatment for their cancer. A recommended dose of rucaparib for Japanese patients will be determined in a dose-escalation portion and then further evaluated in a dose-expansion portion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Rucaparib monotherapy | Experimental | Drug: RucaparibPart I: Dose Escalation, Part II: Dose Expansion (Additional patients will be enrolled at the recommended dose as defined in Part I of the study.) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 20 years of age at the time the informed consent form is signed and of Japanese ethnicity (ie, both parents are native Japanese and were born in Japan).
- Have a solid tumor that has progressed on standard treatment:
- Have to have evaluable disease (i.e. disease can be followed on scans.)
- Be willing and able to fast for at least 14 hours
Key exclusion criteria (6 listed)
- Active second malignancy
- Prior treatment with any PARP inhibitor
- Symptomatic and/or untreated CNS metastases
- Women who are breastfeeding or pregnant
- Pre-existing duodenal stent and/or any gastrointestinal disorder that would interfere with drug absorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RucaparibAlso: CO-338Rucaparib will be administered twice daily | Drug | Oral Rucaparib monotherapy |
Primary outcome
Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability
Time frame: From enrollment to completion of Part I (up to 12 months)
Number of participants with serious AEs as a measure of safety and tolerability
Time frame: From enrollment to completion of Part I (up to 12 months)
Number of participants with worsening laboratory values as a measure of safety and tolerability
Time frame: From enrollment to completion of Part I (up to 12 months)
5 secondary outcomes
Dose-limiting toxicities (DLTs) during Cycle 1 of treatment
Time frame: From enrollment to completion of Part I (up to 12 months)
Area under the plasma concentration versus time curve [AUC]
Time frame: From enrollment to completion of Part I (up to 12 months)
Peak Plasma Concentration [Cmax]
Time frame: From enrollment to completion of Part I (up to 12 months)
Total Plasma Clearance [CI/F]
Time frame: From enrollment to completion of Part I (up to 12 months)
Response to treatment according to RECIST Version 1.1
Time frame: From enrollment to primary completion of study (up to 3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rucaparib in people with Advanced Solid Tumor, run by pharmaand GmbH at 3 sites in Japan.
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 6 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: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability (time frame: From enrollment to completion of Part I (up to 12 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2023.