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motexafin gadolinium

Phase 3

Brain Neoplasms | Small molecule | Oncology |AbbVie Inc.|Trials Updated: Apr 3, 2009

motexafin gadolinium development status

Highest phase Phase 3
Registered trials 10 across 1 sponsor since Feb 2003

motexafin gadolinium target and mechanism

Molecular targetRRM1, RRM2B, RRM2, TXNRD1
Target classInhibitor
ModalitySmall molecule

Also known as Motexafin Gadolinium Injection

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials10
Total Enrollment901

FDA Designations

No designations recorded

motexafin gadolinium clinical trials

motexafin gadolinium · 10 trials · 26 indications

Phase 3 1Phase 2 4Phase 1 5
NCT00054795Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)Brain Neoplasms
COMPLETED550 Analytics
PHASE3COMPLETED
Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
Brain NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC
Clinical response rate
Rate of complete response, partial response and stable disease (clinical benefit rate)
Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
Phase I
To determine the maximum tolerated dose (MTD) of MGd when administered once weekly to patients with relapsed or refractory CLL/SLL
To determine the dose-limiting toxicities (DLTs) of MGd when administered once weekly to patients with relapsed or refractory CLL/SLL
Phase II
To assess the complete and partial response rate in patients with relapsed or refractory CLL/SLL when administered MGd once weekly at the MTD
Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin
Determine the Dose Limiting Toxicity at 3 weeks (1 cycle), and the Maximum Tolerated Dose at 24 weeks (6 cycles).
Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.

Secondary Endpoints

To select the most effective regimen based on tumor response
To estimate the time to progression
To estimate survival
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Motexafin GadoliniumDRUG -
Motexafin Gadolinium InjectionDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites92

Inclusion Criteria: * Adults (≥18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer; * KPS score of ≥70; * Each patient must sign a study-specific Informed Consent form Exclusion Criteria: * Liver metastases; * Extracranial...

Countries:United StatesAustraliaAustriaBelgiumCanadaFranceGermanyNetherlands
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Frequently asked questions about motexafin gadolinium

What is motexafin gadolinium used for?

Motexafin gadolinium is an investigational small molecule being studied in oncology for several cancer types, including chronic lymphocytic leukemia, renal cell carcinoma, non-small-cell lung cancer, breast cancer, glioma, and brain neoplasms. It has been evaluated in Phase 1 and Phase 2 clinical trials, but is not approved for any indication.

What does motexafin gadolinium target?

Motexafin gadolinium targets RRM1, RRM2, RRM2B, and TXNRD1. It acts as an inhibitor of these proteins, which are involved in ribonucleotide reduction and redox regulation. By inhibiting these targets, the drug is thought to disrupt DNA synthesis and cellular antioxidant defenses in cancer cells.

Who is developing motexafin gadolinium?

Motexafin gadolinium is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. The company is responsible for the clinical development of the drug, which is currently in Phase 2 testing.

What phase is motexafin gadolinium in?

Motexafin gadolinium is in Phase 2 clinical development. It has completed two trials, including a Phase 1 study in chronic lymphocytic leukemia and small lymphocytic lymphoma, and a Phase 2 study in renal cell carcinoma. No active trials are currently recruiting.

What clinical trials is motexafin gadolinium in?

Motexafin gadolinium has been studied in completed trials including NCT00290004 (Phase 1 in chronic lymphocytic leukemia or small lymphocytic lymphoma), NCT00134186 (Phase 2 in renal cell cancer), NCT00129844 (Phase 2 in non-small-cell lung cancer), and NCT00120939 (Phase 1 with docetaxel in advanced cancers). All trials are completed.

Is motexafin gadolinium the same as Motexafin Gadolinium Injection?

Yes, Motexafin Gadolinium Injection is another name for motexafin gadolinium. Both terms refer to the same investigational small molecule developed by AbbVie Inc. for oncology indications.