Know Cancer

or
forgot password

A Multi-center, Open Label, First in Human Phase I Dose Escalation Study of Single Agent RO5503781, a Small Molecule MDM2 Antagonist, Administered Orally in Patients With Advanced Malignancies, Except Leukemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms

Thank you

Trial Information

A Multi-center, Open Label, First in Human Phase I Dose Escalation Study of Single Agent RO5503781, a Small Molecule MDM2 Antagonist, Administered Orally in Patients With Advanced Malignancies, Except Leukemia


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed advanced malignancies, except all forms of
leukemia, for which standard curative or palliative measures do not exist, are no
longer effective, or are not acceptable to the patient

- Measurable disease (according to RECIST or Cheson criteria) or evaluable disease
prior to administration of study drug

- Minimum weight of 35 kg

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Acute toxicities from any prior anti-tumor therapy, surgery, or radiotherapy must
have resolved to NCT-CTCAE Grade
- Adequate renal, hepatic and bone marrow function

Exclusion Criteria:

- History of any form of leukemia except for Stage 0 and 1 chronic lymphocytic leukemia
(CLL) not requiring treatment in addition to the underlying solid tumor

- Use of other investigational agents or having received investigational drugs weeks prior to study treatment start

- History of seizure disorders or unstable CNS metastases

- Severe and/or uncontrolled cardiovascular disease or disorder

- Active (acute or chronic) or uncontrolled infection

- Pregnant or breastfeeding women

- HIV-positive patients who are currently receiving anti-retroviral treatment

- Known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia

- Patients receiving oral or parenteral anticoagulants/antiplatelet agents;
anticoagulant flushes for maintenance of indwelling catheters are allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD), schedules A + B

Outcome Time Frame:

approximately 1.5 years

Safety Issue:

Yes

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Agence Francaise de Securite Sanitaire des Produits de Sante

Study ID:

NP27872

NCT ID:

NCT01462175

Start Date:

November 2011

Completion Date:

November 2013

Related Keywords:

  • Neoplasms
  • Neoplasms
  • Leukemia

Name

Location