Chiauranib for Advanced Solid Malignant Tumors and Relapsed/Refractory SCLC.

Part of paid clinical trials in Encinitas, California.

Sponsor
Chipscreen Biosciences, Ltd.
Study ID
NCT05271292
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chiauranib — DRUG
    Phase 1b: Each patient will undergo both a single-dose period (6 days) and a consecutive-dose (1 cycle of 28 days) period Phase 2: Patients will take the RP2D once daily for 28-day cycles continuously with no interruption between cycles

Study Details

This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages: Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods) Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with no interruption between cycles.

Key Dates

Start date
Aug 26, 2022
Status verified
Jul 2024
Primary completion
Mar 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Study arm (35 mg)
    Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
  • Experimental: Study arm (50 mg)
    Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)
  • Experimental: Study arm (65 mg)
    Phase 1b: Patients will be enrolled sequentially in 3 dose-escalating cohorts (Chiauranib capsules 35, 50, and 65 mg, orally)

Primary Outcome Measure

Incidence of adverse events (AEs) and other safety parameters [ Time Frame: Until 30 days after a patient takes the last dose of the study drug ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
California Cancer Associates-EncintasEncinitasCalifornia92024
Christina Spencer
[email protected]
760-452-3909
Alberto Besseduo, MD (PRINCIPAL_INVESTIGATOR)
Providence/St. Joe Cancer Institute/Crosson Cancer InstituteFullertonCalifornia92835
Mirza "Hadi" Al Baig
[email protected]
Yung Lyou, MD (PRINCIPAL_INVESTIGATOR)
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322
Mashunte Holmes
[email protected]
Jennifer Carlisle (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstitueBostonMassachusetts02215
Diandra Ocot
[email protected]
Jacob Sands, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Hirva Mamdani, MD
[email protected]
313-576-8711
Hirva Mamdani, MD (PRINCIPAL_INVESTIGATOR)
Comprehensive Cancer Centers of NevadaLas VegasNevada89119
Ann Lovelace
[email protected]
702-952-3449
Liawaty Ho (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer Center ResearchCantonOhio44718
Nashat Gabrail, MD
[email protected]
330-492-3345
Nashat Gabrail, MD (PRINCIPAL_INVESTIGATOR)
OU HealthOklahoma CityOklahoma73104
Christina Caldwell
[email protected]
405-271-8001
Abdul Rafeh Naqash (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research CenterNashvilleTennessee37203
David R Spigel, MD
[email protected]
615-329-7294
North Houston Cancer ClinicsHuntsvilleTexas77340
Elham Abbasi, MD
[email protected]
936-439-5213
Roham Garvashi, MD
[email protected]
(936)439-5213
Elham Abbasi, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Carrie Friedman
[email protected]
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)

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By research site
California Cancer Associates-Encintas· Encinitas, CAProvidence/St. Joe Cancer Institute/Crosson Cancer Institute· Fullerton, CAWinship Cancer Institute of Emory University· Atlanta, GADana Farber Cancer Institue· Boston, MAKarmanos Cancer Institute· Detroit, MIComprehensive Cancer Centers of Nevada· Las Vegas, NV

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