Trial Outcomes & Findings for A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study (NCT NCT00096941)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline to the end of the study (up to 2 years, 5 months)

Results posted on

2015-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Pertuzumab Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Pertuzumab Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.
Overall Study disease progression	3

Baseline Characteristics

A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pertuzumab n=3 Participants Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to the end of the study (up to 2 years, 5 months)

Population: Safety population: Participants who received at least 1 dose of pertuzumab. Percentage of participants

Outcome measures

Outcome measures
Measure	Pertuzumab n=3 Participants Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.
Percentage of Participants Who Experienced an Adverse Event	33.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline to the end of the study (up to 2 years, 5 months)

Population: Safety population: Participants who received at least 1 dose of pertuzumab.

A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.

Outcome measures

Outcome measures
Measure	Pertuzumab n=3 Participants Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) Complete response	0.0 percentage of participants
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) Partial response	0.0 percentage of participants
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) Stable disease	33.3 percentage of participants
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) Progressive disease	33.3 percentage of participants
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) Unknown	33.3 percentage of participants

Adverse Events

Pertuzumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pertuzumab n=3 participants at risk Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression. Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation.
Investigations EJECTION FRACTION DECREASED	33.3% 1/3 Safety population: Participants who received at least 1 dose of pertuzumab.

Additional Information

Medical Communications

Genentech, Inc.

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER