A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

NCT03499444 | Completed Phase 1 FDA Drug

• 1 other identifier: CO-338-081
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability

  From enrollment to completion of Part I (up to 12 months)

• Number of participants with serious AEs as a measure of safety and tolerability

  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

  From enrollment to completion of Part I (up to 12 months)

Secondary Outcomes (5)

• Dose-limiting toxicities (DLTs) during Cycle 1 of treatment

  From enrollment to completion of Part I (up to 12 months)

• Area under the plasma concentration versus time curve [AUC]

  From enrollment to completion of Part I (up to 12 months)

• Peak Plasma Concentration [Cmax]

  From enrollment to completion of Part I (up to 12 months)

• Total Plasma Clearance [CI/F]

  From enrollment to completion of Part I (up to 12 months)

• Response to treatment according to RECIST Version 1.1

  From enrollment to primary completion of study (up to 3 years)

Study Arms (1)

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.)

Drug: Rucaparib

Interventions

Rucaparib DRUG

Rucaparib will be administered twice daily

Also known as: CO-338

Oral Rucaparib monotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• pharmaand GmbH: lead

Study Sites (3)

Division of Medical Oncology, Hyogo Cancer Center

Akashi, Hyōgo, 673-8558, Japan

Location

Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center

Hidaka, Saitama, 350-1298, Japan

Location

Department of Breast and Medical Oncology, National Cancer Center Hospital

Tsukiji, Tokyo, 104-0045, Japan

Location

MeSH Terms

Interventions

rucaparib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 17, 2018
• Study Start: February 6, 2018
• Primary Completion: June 18, 2019
• Study Completion: April 13, 2022
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

JP (3)