Recent Updates
Recently added Catalysts

Motexafin Gadolinium

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment550

FDA Designations

No designations recorded

Clinical trial landscape

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 Neoplasms
NCT00054795550
Unlock 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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Motexafin GadoliniumDRUG -
Motexafin Gadolinium InjectionDRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Motexafin Gadolinium

What is Motexafin Gadolinium used for?

Motexafin Gadolinium is an investigational small molecule being studied in oncology. It has been evaluated in clinical trials for brain neoplasms, including glioma and glioblastoma, non-Hodgkin's lymphoma, non-small-cell lung carcinoma, and adenocarcinoma. It is not approved by the FDA and remains in clinical development.

Who is developing Motexafin Gadolinium?

Motexafin Gadolinium is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is Motexafin Gadolinium in?

Motexafin Gadolinium has completed Phase 1 and Phase 2 clinical trials. The most advanced studies were Phase 2 trials, including one for non-Hodgkin's lymphoma and one for second-line treatment of non-small-cell lung cancer. The drug is investigational and not FDA approved.

What clinical trials has Motexafin Gadolinium been in?

Motexafin Gadolinium has been studied in several completed trials. NCT00080054 tested it with temozolomide for malignant gliomas. NCT00086034 evaluated it for non-Hodgkin's lymphoma. NCT00102505 combined it with docetaxel and cisplatin for non-small-cell lung cancer, and NCT00129844 studied it as second-line treatment for non-small-cell lung cancer.

Is Motexafin Gadolinium the same as MGd?

Yes, Motexafin Gadolinium is also known as MGd. Clinical trial titles refer to MGd, such as NCT00102505, which studied MGd in combination with docetaxel and cisplatin, and NCT00129844, which studied MGd for second-line treatment of non-small-cell lung cancer.