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A Phase I Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib (BSI-201) in Multiple Non Operable Brain Metastases

Phase 1
18 Years
Open (Enrolling)
Brain Metastases

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Trial Information

A Phase I Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib (BSI-201) in Multiple Non Operable Brain Metastases

Inclusion Criteria:

- Non operable brain metastases from any type of cancer (≥ 2)

- At least one measured brain target available ≥ 1 cm (T1-weighted sequences with
contrast application MRI)

- No stereotaxie indication

- Any anterior treatments for systemic disease (any chemotherapy at any line) are
accepted but have to be interrupted at least 15 days before and up to 30 days after
the present protocol

- No extra-brain disease or stabilized since at least 1 month

- Aged ≥ 18 years old

- KPS > 70 (RPS class I or II)

- Adequate bone marrow function: WBC ≥ 3.5 x 109/L, ANC ≥ 1.5 x 109/L, Platelets ≥ LLN,
Hb > 10g/dL,

- Adequate renal function: serum creatinine ≤ 1.5 × ULN and blood urea nitrogen ≤ 25

- Male or female patient using adequate contraceptive method

- Women of childbearing potential must have a negative serum or urine pregnancy test
within 3 days prior to the start of treatment

- Informed and signed consent

- Able to be followed according to the terms of the protocol

- Affiliated to the French National social security

Exclusion Criteria:

- Anterior treatment for brain metastases (surgery, radiosurgery, stereotaxie)

- Leptomeningeal metastases

- Inclusion in another protocol within 30 days

- Brain metastases with severe intracranial hypertension clinical signs

- Other cancer except the known primary tumor or in situ cervix cancer or basocellular

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the Maximum Tolerated Dose (MTD)

Outcome Description:

The MTD is defined as the dose level at which the Dose Limiting Toxicity (DLT) is observed in more than 20% of patients. The DLT is defined as: Any treatment-related toxicity CTC v4.0 ≥ grade 3(CTC-AE v4.0 grading scale)

Outcome Time Frame:

Until 12 week follow-up

Safety Issue:


Principal Investigator

David Azria, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CRLC Val d'Aurelle-Paul Lamarque


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2012

Completion Date:

March 2014

Related Keywords:

  • Brain Metastases
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms