A First-In-Human Study of RO5503781 in Patients With Advanced Malignancies, Except Leukemia
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01462175
First received: October 27, 2011
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This multicenter, open label, dose-escalating study will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of RO5503781 in patients with advanced malignancies except leukemia. Patients will receive multiple escalating oral doses in two different dosing schedules. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: RO5503781 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Maximum tolerated dose (MTD), schedules A + B [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: Yes ]
- Dose limiting toxicities (DLTs) [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: Yes ]
- Safety: Incidence of adverse events [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetics: blood/urine concentrations [ Time Frame: up to 22 days ] [ Designated as safety issue: No ]
- Pharmacodynamic assessments (plasma/serum/tumor biomarkers) [ Time Frame: up to 22 days ] [ Designated as safety issue: No ]
- Clinical response (tumor assessments according to RECIST criteria or Cheson criteria) [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
- Food effect on pharmacokinetics: blood levels after administration in fasted vs fed state [ Time Frame: 22 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: RO5503781
Multiple ascending doses orally, once weekly x 3 followed by 13 days of rest
|
| Experimental: B |
Drug: RO5503781
Multiple ascending doses orally, daily x 5 followed by 23 days of rest
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 </=1
- 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 </= 4 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462175
Contacts
| Contact: Please reference Study ID Number: NP27872 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Australia | |
| Recruiting | |
| Melbourne, Australia, 3002 | |
| Canada, Ontario | |
| Completed | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Active, not recruiting | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Active, not recruiting | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| France | |
| Completed | |
| Bordeaux, France, 33076 | |
| Active, not recruiting | |
| Lyon, France, 69373 | |
| Korea, Republic of | |
| Recruiting | |
| Seoul, Korea, Republic of, 110-744 | |
| Netherlands | |
| Recruiting | |
| Groningen, Netherlands, 9713 GZ | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01462175 History of Changes |
| Other Study ID Numbers: | NP27872, 2011-002767-15 |
| Study First Received: | October 27, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | France: Agence Francaise de Securite Sanitaire des Produits de Sante |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 21, 2013