NeoplasmsPhase 1NCT00027027

Safety Study of rhuMAb 2C4 to Treat Advanced Solid Tumors

A Phase 1 study testing rhuMAb 2C4 in people with Neoplasms, run by Genentech, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: rhuMAb 2C4
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Nov 2001to Aug 2003
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent
Age >=18 years old
ECOG performance status of 0 or 1 (see Appendix F)
Life expectancy of >=12 weeks
Histologically documented, incurable, locally advanced or metastatic solid malignancies
Disease progression on or after standard effective therapy or a malignancy for which there is no standard therapy

Show all 13Show fewer

At least one bi-dimensionally measurable lesion (>=2 cm [>=1 cm on spiral CT scan])
HER2-negative status as defined by fluorescence in situ hybridization (FISH) testing (only for subjects with breast cancer)
Use of an effective means of contraception for women of childbearing potential
Granulocyte count of >=1500/uL, platelet count of >=100,000/uL, and hemoglobin of >=9 g/dL
Serum bilirubin less than or equal to the upper limit of normal (ULN) and alkaline phosphatase, AST, and ALT <=2.5x ULN (ALT and AST <=5x ULN for subjects with liver metastases; alkaline phosphatase <=5x ULN for subjects with liver or bone metastases)
Serum creatinine less than or equal to ULN or creatinine clearance of >=60 mL/min
International normalized ratio (INR) of <1.3 and activated partial thromboplastin time (aPTT) of <1.5x ULN

Who cannot join

Pleural effusions, ascites, or bone lesions as the only manifestation of the current cancer
Symptomatic or untreated brain metastases
Prior chemotherapy, hormonal therapy (except for androgen-deprivation therapy for subjects with prostate cancer), radiotherapy, or immunotherapy within 4 weeks of Day 1 (within 6 weeks for nitrosoureas or mitomycin)
Prior treatment with Herceptin
Prior cumulative doxorubicin dose of >360 mg/m2 or the equivalent
History of other malignancies within 5 years of Day 1 except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer

Show all 16Show fewer

History of significant cardiac disease, unstable angina, congestive heart failure, myocardial infarction, or ventricular arrhythmia requiring medication
Ejection fraction of <50% or below the lower limit of normal determined by ECHO (Subjects who are unable to have ejection fraction evaluated by ECHO may have ejection fraction evaluated by a MUGA scan, although this must be discussed with the Medical Monitor prior to enrollment.)
Active infection requiring IV antibiotics
Uncontrolled hypercalcemia (>11.5 mg/dL)
Clinically important history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Known human immunodeficiency virus (HIV) infection
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
Major surgery or significant traumatic injury within 3 weeks of Day 1
Pregnancy or lactation
Inability to comply with study and follow-up procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90211

Other trials in United States

About this study

Official title: A Phase I, Open-Label, Multicenter, Dose-Escalation Study of the Safety and Pharmacokinetics of a Recombinant Humanized Antibody to Her2 (rhuMAb 2C4) Administered Every 3 Weeks to Subjects With Advanced Solid Malignancies

The purpose of this Phase I study is to test the safety of rhuMAb 2C4 to see what effects (good and bad) it has on patients with certain types of cancer, and also to find the highest dose of rhuMAb that can be given without causing severe side effects. All study participants will be assigned to specific group to evaluate different dosages of rhuMAb 2C4. The study is scheduled to run for up to one year depending on how patients respond to the study treatment.

Conditions: Neoplasms
Being tested: rhuMAb 2C4
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rhuMAb 2C4Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death
For this protocol, an AE is defined any untoward medical occurrence (e.g., sign, symptom, disease, syndrome, intercurrent illness, abnormal laboratory finding) that emerges or worsens relative to pretreatment baseline during the treatment or post-treatment periods, regardless of the suspected cause.
For this protocol an SAE was defined as any AE that occurred at any dose if:
- It resulted in death (i.e., the AE caused or led to death),
- It was life threatening,
- It required or prolonged inpatient hospitalization,
- It was disabling,
- It resulted in a congenital anomaly/birth defect,
- It may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above.
The primary cause of death for all reported cases was disease progression, and all of the deaths occurred following study discontinuation, with one death occurring within 4 weeks of the last treatment day.
Measured: Days 1, 2, 5, 8, and 15 of Cycle 1; Days 1, 8, and Week 3, of Cycles 2 and beyond up to 1 year and at the follow-up visit (4 weeks after last infusion)
Number of Participants With Dose-Limiting Toxicities (DLTs)
Incidence of DLTs defined as any Grade 3 or 4 major organ toxicity according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2 or any subjectively intolerable toxicity felt by the investigator to be related to rhuMAb 2C4.
One participant in the 15.0 mg/kg dose group experienced a gastrointestinal hemorrhage on Day 16. This event was judged by the investigator to be related to study drug. The participant recovered in 3 days and continued to receive rhuMAb 2C4 beyond Cycle 2.This was the only DLT reported during the first two treatment cycles.
Measured: Day 1 of Cycles 1 and 2, and 24 hours after Cycle 2 infusion

Secondary outcomes (6)

Pharmacokinetic Measurement of Area Under the Curve (AUC)
Mean rhuMAb 2C4 serum concentrations versus nominal time profiles for the first two treatment cycles are presented for AUC micrograms per milliliters (ug/mL) by day. A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.
Measured: Days 1 (predose, 89 minutes following start of infusion and at 1.5, 4, and 8 hours postdose) 2, 5, 8 and 15 of Cycle 1; Days 1 (predose and 29 minutes following start of infusion) and 8 of Cycle 2
Pharmacokinetic Measurement of Systemic Clearance (CL)
A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.
Measured: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)
Pharmacokinetic Measurement of Volume of Central Compartment (Vc)
A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.
Measured: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)
Pharmacokinetic Measurement of Steady-State Volume of Distribution (Vss)
A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.
Measured: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)
Pharmacokinetic Measurement of Initial Distribution Half-Life (t1/2 Initial)
A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.
Measured: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)
Pharmacokinetic Measurement of Terminal Half-Life (t1/2 Terminal) in Days
A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2-15 mg/kg dose groups.
Measured: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2001Aug 2003

First posted16 Nov 2001 (estimated)
Study startNov 2001
Primary completionAug 2003
Study completionAug 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00027027
Sponsor's protocol ID: TOC2297g
Status last verified: Jul 2015
First submitted: 15 Nov 2001
Last updated: 27 Jul 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-Label, Multicenter, Dose-Escalation Study of the Safety and Pharmacokinetics of a Recombinant Humanized Antibody to Her2 (rhuMAb 2C4) Administered Every 3 Weeks to Subjects With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT00027027
Acronym / sponsor ID: TOC2297g
Conditions: Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2001
Primary completion: Aug 2003 (actual)
Study completion: Aug 2003 (actual)
First posted: 16 Nov 2001 (estimated)
Results: Posted 27 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Signed informed consent
Age >=18 years old
ECOG performance status of 0 or 1 (see Appendix F)
Life expectancy of >=12 weeks
Histologically documented, incurable, locally advanced or metastatic solid malignancies

Key exclusion criteria (16 listed)

Pleural effusions, ascites, or bone lesions as the only manifestation of the current cancer
Symptomatic or untreated brain metastases
Prior chemotherapy, hormonal therapy (except for androgen-deprivation therapy for subjects with prostate cancer), radiotherapy, or immunotherapy within 4 weeks of Day 1 (within 6 weeks for nitrosoureas or mitomycin)
Prior treatment with Herceptin
Prior cumulative doxorubicin dose of >360 mg/m2 or the equivalent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rhuMAb 2C4	Drug	–

Primary outcome

Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death
Time frame: Days 1, 2, 5, 8, and 15 of Cycle 1; Days 1, 8, and Week 3, of Cycles 2 and beyond up to 1 year and at the follow-up visit (4 weeks after last infusion)
For this protocol, an AE is defined any untoward medical occurrence (e.g., sign, symptom, disease, syndrome, intercurrent illness, abnormal laboratory finding) that emerges or worsens relative to pretreatment baseline during the treatment or post-treatment periods, regardless of the suspected cause. For this protocol an SAE was defined as any AE that occurred at any dose if: * It resulted in death (i.e., the AE caused or led to death), * It was life threatening, * It required or prolonged inpatient hospitalization, * It was disabling, * It resulted in a congenital anomaly/birth defect, * It may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above. The primary cause of death for all reported cases was disease progression, and all of the deaths occurred following study discontinuation, with one death occurring within 4 weeks of the last treatment day.
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 of Cycles 1 and 2, and 24 hours after Cycle 2 infusion
Incidence of DLTs defined as any Grade 3 or 4 major organ toxicity according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2 or any subjectively intolerable toxicity felt by the investigator to be related to rhuMAb 2C4. One participant in the 15.0 mg/kg dose group experienced a gastrointestinal hemorrhage on Day 16. This event was judged by the investigator to be related to study drug. The participant recovered in 3 days and continued to receive rhuMAb 2C4 beyond Cycle 2.This was the only DLT reported during the first two treatment cycles.

6 secondary outcomes

Pharmacokinetic Measurement of Area Under the Curve (AUC)
Time frame: Days 1 (predose, 89 minutes following start of infusion and at 1.5, 4, and 8 hours postdose) 2, 5, 8 and 15 of Cycle 1; Days 1 (predose and 29 minutes following start of infusion) and 8 of Cycle 2
Pharmacokinetic Measurement of Systemic Clearance (CL)
Time frame: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)
Pharmacokinetic Measurement of Volume of Central Compartment (Vc)
Time frame: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)
Pharmacokinetic Measurement of Steady-State Volume of Distribution (Vss)
Time frame: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)
Pharmacokinetic Measurement of Initial Distribution Half-Life (t1/2 Initial)
Time frame: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)
Pharmacokinetic Measurement of Terminal Half-Life (t1/2 Terminal) in Days
Time frame: Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)

Results and safety

Results posted to the registry on 27 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rhuMAb 2C4: 0.5 Milligrams Per Kilogram (mg/kg)	3	0
rhuMAb 2C4: 2 mg/kg	3	0
rhuMAb 2C4: 5 mg/kg	4	0
rhuMAb 2C4: 10 mg/kg	3	0
rhuMAb 2C4: 15 mg/kg	8	0

Primary outcome: Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death

Time frame: Days 1, 2, 5, 8, and 15 of Cycle 1; Days 1, 8, and Week 3, of Cycles 2 and beyond up to 1 year and at the follow-up visit (4 weeks after last infusion). Number. Unit: participants

Measure	rhuMAb 2C4: 0.5 mg/kg n = 3	rhuMAb 2C4: 2 mg/kg n = 3	rhuMAb 2C4: 5 mg/kg n = 4	rhuMAb 2C4: 10 mg/kg n = 3	rhuMAb 2C4: 15 mg/kg n = 8
Adverse events	3	3	4	3	8
Serious adverse events	3	1	2	0	5
Death	3	1	2	0	1

Population analysed: All enrolled participants

Primary outcome: Number of Participants With Dose-Limiting Toxicities (DLTs)

Time frame: Day 1 of Cycles 1 and 2, and 24 hours after Cycle 2 infusion. Number. Unit: participants

Measure	rhuMAb 2C4: 0.5 mg/kg n = 3	rhuMAb 2C4: 2 mg/kg n = 3	rhuMAb 2C4: 5 mg/kg n = 3	rhuMAb 2C4: 10 mg/kg n = 3	rhuMAb 2C4: 15 mg/kg n = 7
Value	3	1	2	0	6

Population analysed: All enrolled participants who completed at least 2 cycles of study treatment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline through 4 weeks after the last infusion of study drug, up to 56 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rhuMAb 2C4: 0.5 mg/kg	3 of 3 (100%)	3 of 3 (100%)	Not reported
rhuMAb 2C4: 2 mg/kg	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
rhuMAb 2C4: 5 mg/kg	2 of 4 (50%)	4 of 4 (100%)	Not reported
rhuMAb 2C4: 10 mg/kg	0 of 3 (0%)	3 of 3 (100%)	Not reported
rhuMAb 2C4: 15 mg/kg	5 of 8 (62.5%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rhuMAb 2C4 in people with Neoplasms, run by Genentech, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death (time frame: Days 1, 2, 5, 8, and 15 of Cycle 1; Days 1, 8, and Week 3, of Cycles 2 and beyond up to 1 year and at the follow-up visit (4 weeks after last infusion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00027027.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.