Recent Updates
Recently added Catalysts

RG1507

Phase 2

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Trials Updated: Nov 2, 2016

RG1507 development status

Highest phase Phase 2 (NCT00642941)
Phase scored for RHHBYPhase 1
Registered trials 9 across 1 sponsor since Nov 2006

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment140

FDA Designations

No designations recorded

RG1507 clinical trials

RG1507 · 3 trials · 2 indications

Phase 1 3
NCT00882674A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast CancerBreast Cancer
COMPLETED8 Analytics
NCT00560144A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.Neoplasms
COMPLETED34 Analytics
NCT00400361A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.Neoplasms
COMPLETED98 Analytics
PHASE1COMPLETED
A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer
Breast CancerUnlock trial analytics
PHASE1COMPLETED
A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
NeoplasmsUnlock trial analytics
PHASE1COMPLETED
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent reduction in IGF-1R expression
From initial diagnosis to tumor excision
Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
Throughout study
AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life
Throughout study

Secondary Endpoints

Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue
Days 1, 8 and 31
Adverse events, laboratory parameters
Throughout study
MTD (AEs, laboratory parameters)
Throughout study
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -

Interventions

NameTypeDescription
RG1507DRUG16mg/kg, 9mg/kg, 3mg/kg or 1mg/kg iv on Day 1 in one of 4 cohorts of patients
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * female patients, \>=18 years of age; * invasive, and operable, breast cancer; * ECOG Performance Status of 0 or 1. Exclusion Criteria: * evidence of metastatic disease; * inflammatory breast cancer; * prior hormonal or systemic therapy for breast cancer; * prior treatment wi...

Countries:United KingdomUnited States
Unlock Eligibility Criteria

Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about RG1507

What is RG1507 used for?

RG1507 is an investigational small molecule being studied for the treatment of neoplasms, including advanced solid tumors and breast cancer. It has been evaluated in Phase 1 clinical trials in patients with these conditions.

Who makes RG1507?

RG1507 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of this investigational drug in oncology.

What phase is RG1507 in?

RG1507 is in Phase 1 clinical development. All three of its trials are Phase 1 studies that have been completed. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is RG1507 in?

RG1507 has been studied in three completed Phase 1 trials: NCT00400361 in adults with advanced solid tumors, NCT00560144 in children and adolescents with advanced solid tumors, and NCT00882674 in women with operable breast cancer.

Is RG1507 the same as R1507?

Yes, RG1507 is also known as R1507. The clinical trial records use the name R1507, and RG1507 is the same investigational drug being developed by Roche.