An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | November 2012 |
| End Date: | November 2016 |
A Multi-Center, Open-Label, Extension Study of RO5045337 (MDM2 Antagonist) Administered Orally in Patients Treated With RO5045337 on Previous Roche-Sponsored Phase 1 Cancer Studies
This open-label, extension study is designed to provide continuing treatment with RO5045337
to participants who have completed parent studies NO21279 (NCT00623870), NO21280
(NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).
Participants are eligible to participate in this study if they have completed required Phase
1 study assessments for primary objectives of respective parent protocol and are having
evidence of clinical benefit (as defined by the parent protocol). Participants will continue
the most similar dose and formulation available (which does not exceed the maximum tolerated
dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and
the same schedule of RO5045337 treatment that they were receiving at the time of
transitioning from the parent clinical study protocol.
to participants who have completed parent studies NO21279 (NCT00623870), NO21280
(NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296).
Participants are eligible to participate in this study if they have completed required Phase
1 study assessments for primary objectives of respective parent protocol and are having
evidence of clinical benefit (as defined by the parent protocol). Participants will continue
the most similar dose and formulation available (which does not exceed the maximum tolerated
dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and
the same schedule of RO5045337 treatment that they were receiving at the time of
transitioning from the parent clinical study protocol.
Inclusion Criteria:
- Participants must meet the inclusion criteria outlined in the respective parent
protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033),
NP28021 (NCT01605526) or NP28023 (NCT01635296)
- Participants must have completed one of the following clinical study protocols and
have been determined to have clinical benefit on treatment at the conclusion of
required study analyses as defined in the respective parent protocols: NO21279
(NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or
NP28023 (NCT01635296)
Exclusion Criteria:
- Participants must meet the exclusion criteria outlined in the respective parent
protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033),
NP28021 (NCT01605526) or NP28023 (NCT01635296)
- Participants who developed disease progression/ requiring other anti-tumor therapy
while in the parent protocol
- Participants who have stopped study drug dosing for greater than 56 days
- Participants continuing to require dose modifications
- Participants with worsening adverse events
- Participants with unrelated adverse events, medical illnesses, or changes in
performance status that, per investigator discretion, put them at high risk for
continuing participation in the clinical study
We found this trial at
5
sites
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