A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma
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:
NCT01605526
First received: May 4, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: RO5045337 Drug: doxorubicin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Maximum tolerated dose/dose-limiting toxicities [ Time Frame: approximately 12 months ] [ Designated as safety issue: Yes ]
- Safety: Incidence of adverse events [ Time Frame: approximately 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetics of RO5045337 and doxorubicin in combination therapy: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and up to 72 hours post-dose Days 1 and 5 of Cycle 1 ] [ Designated as safety issue: No ]
- Pharmacodynamics: Serum macrophage inhibitory cytokine-1 (MIC-1) levels [ Time Frame: Pre-dose and up to 72 hours post-dose on Days 1 and 5 of Cycle 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: RO5045337
Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles
Drug: doxorubicin
60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles
|
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 soft tissue sarcoma
- Evaluable disease according to RECIST version 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Eligible for doxorubicin therapy
- Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade </= 1 prior to start of study
- Adequate bone marrow, hepatic and renal function
- Patients with stable CNS metastases are eligible
Exclusion Criteria:
- Previous treatment with limiting doses of doxorubicin
- Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment </= 28 days from Day 1 dosing on study treatment
- History of seizure disorders or unstable CNS metastases
- Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
- Pregnant or breastfeeding women
- HIV positive patients who are currently receiving combination anti-retroviral therapy
- Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
- Patients receiving oral or parenteral anti-coagulants/anti-platelet agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605526
Contacts
| Contact: Please reference Study ID Number: NP28021 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, California | |
| Completed | |
| Santa Monica, California, United States, 90403 | |
| United States, Massachusetts | |
| Completed | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New Jersey | |
| Recruiting | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Pennsylvania | |
| Recruiting | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Utah | |
| Completed | |
| Salt Lake City, Utah, United States, 84112 | |
| France | |
| Active, not recruiting | |
| Bordeaux, France, 33076 | |
| Completed | |
| Lyon, France, 69373 | |
| Completed | |
| Toulouse, France, 31052 | |
| Completed | |
| Villejuif, France, 94805 | |
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: | NCT01605526 History of Changes |
| Other Study ID Numbers: | NP28021, 2011-006279-21 |
| Study First Received: | May 4, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013