Solid CancersPhase 1NCT00977067
A Study of the Safety and Pharmacokinetics of GDC-0152, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies
A Phase 1 study testing GDC-0152 in people with Solid Cancers, run by Genentech, Inc..
Trial summary
The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers
- What is being tested?
- GDC-0152
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically documented, incurable, locally advanced or metastatic solid malignancies, or non-Hodgkin's lymphoma (NHL) without leukemic phase
- Disease (either target or non-target lesions) that can be assessed by imaging studies and/or physical examination
- For patients with solid tumors or NHL without leukemic phase, disease progression on or after standard therapy, or a malignancy for which there is no standard therapy
- All prior therapy-related toxicities have recovered to baseline-grade toxicity with the exception of alopecia.
- Life expectancy of ≥ 60 days
- Resting oxygen saturation ≥ 92% on room air
- Agreement to use an effective form of contraception for the duration of the study
Who cannot join
- History of central nervous system disease
- Chemotherapy, cancer hormonal therapy (except GnRH agonists), radiotherapy, or immunotherapy within 4 weeks prior to Day 1 (6 weeks for nitrosoureas or mitomycin)
- Use of any other investigational agent or device
- Major surgery or significant traumatic injury within 3 weeks prior to Day 1
- Pregnant or nursing
- Clinically significant cardiovascular disease, New York Heart Association (NYHA) Classification Grade 2 or greater congestive heart failure, a ventricular arrhythmia requiring medication within 1 year prior to Day 1, or NYHA Grade 2 or greater peripheral vascular disease on Day 1
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- Known HIV infection
- Patients with ongoing inflammatory processes or a Grade ≥ 2 fever or Grade ≥ 2 fever-associated constitutional symptoms (including rigors/chills, sweating, and others determined by the investigator), or a clinically significant systemic infection within the last month
- 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 renders the patient at high risk from treatment complications
- History of any chronic liver disease, active hepatic infection, or evidence of hepatic cirrhosis, or Grade ≥ 2 liver dysfunction.
- Baseline oxygen requirement or history of pulmonary fibrosis
- Any signs or symptoms Grade ≥ 2 by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0, at study entry except for alopecia, pain, asymptomatic Grade 2 diffusing capacity of the lung for carbon monoxide (at the discretion of the investigator) or where otherwise specified
- Patients who need to take a concomitant medication, dietary supplement, or food that is a known inhibitor/inducer of the CYP3A4/5 and/or the 2C8 metabolic pathway or that has a narrow therapeutic window and involves these enzymes for their metabolism
About this study
Official title: A Phase Ia, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0152, an IAP Protein Antagonist, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies
The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.
- Conditions
- Solid Cancers
- Being tested
- GDC-0152
- Keywords
- GDC0152, IAP, IAP Antagonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0152Drug
Intravenous escalating dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: GDC-0152 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and nature of dose-limiting toxicities
Measured: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Measured: Through study completion or early study discontinuation
Secondary outcomes (1)
Pharmacokinetic parameters of GDC-0152 (total plasma exposure, maximum plasma concentration, and total plasma clearance)
Measured: Through study completion or early study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startJun 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: The study was terminated early by the Sponsor for reasons unrelated to patient safety or anti-tumor activity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid CancersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iris Chan, M.D., Ph.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977067
- Sponsor's protocol ID
- IAP4050g
- Status last verified
- Jun 2017
- First submitted
- 12 Sep 2009
- Last updated
- 21 Jun 2017
- Results posted
- No
Publications
Shin YG, Jones SA, Murakami SC, Budha N, Ware J, Wong H, Buonarati MH, Dean B, Hop CE. Validation and application of a liquid chromatography-tandem mass spectrometric method for the determination of GDC-0152 in human plasma using solid-phase extraction. Biomed Chromatogr. 2013 Jan;27(1):102-10. doi: 10.1002/bmc.2754. Epub 2012 May 24.
PubMed 22623056
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0152, an IAP Protein Antagonist, Administered Intravenously to Patients With Locally Advanced or Metastatic Malignancies
- ClinicalTrials.gov ID
- NCT00977067
- Acronym / sponsor ID
- IAP4050g
- Conditions
- Solid Cancers
- Keywords
- GDC0152, IAP, IAP Antagonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early by the Sponsor for reasons unrelated to patient safety or anti-tumor activity.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study consists of two stages. In Stage 1, maximum tolerated dose (MTD) will be determined. In Stage 2, additional patients will be treated at the MTD of GDC-0152.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: GDC-0152 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically documented, incurable, locally advanced or metastatic solid malignancies, or non-Hodgkin's lymphoma (NHL) without leukemic phase
- Disease (either target or non-target lesions) that can be assessed by imaging studies and/or physical examination
- For patients with solid tumors or NHL without leukemic phase, disease progression on or after standard therapy, or a malignancy for which there is no standard therapy
- All prior therapy-related toxicities have recovered to baseline-grade toxicity with the exception of alopecia.
- Life expectancy of ≥ 60 days
Key exclusion criteria (13 listed)
- History of central nervous system disease
- Chemotherapy, cancer hormonal therapy (except GnRH agonists), radiotherapy, or immunotherapy within 4 weeks prior to Day 1 (6 weeks for nitrosoureas or mitomycin)
- Use of any other investigational agent or device
- Major surgery or significant traumatic injury within 3 weeks prior to Day 1
- Pregnant or nursing
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 |
|---|---|---|
| GDC-0152Intravenous escalating dose | Drug | A |
Primary outcome
Incidence and nature of dose-limiting toxicities
Time frame: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation
1 secondary outcome
Pharmacokinetic parameters of GDC-0152 (total plasma exposure, maximum plasma concentration, and total plasma clearance)
Time frame: Through study completion or early study discontinuation
Results and safety
The study was stopped early (reason given: The study was terminated early by the Sponsor for reasons unrelated to patient safety or anti-tumor activity.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Derived from this study: PubMed 22623056Shin YG, Jones SA, Murakami SC, Budha N, Ware J, Wong H, Buonarati MH, Dean B, Hop CE. Validation and application of a liquid chromatography-tandem mass spectrometric method for the determination of GDC-0152 in human plasma using solid-phase extraction. Biomed Chromatogr. 2013 Jan;27(1):102-10. doi: 10.1002/bmc.2754. Epub 2012 May 24.
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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.
Iris Chan, M.D., Ph.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0152 in people with Solid Cancers, run by Genentech, Inc..
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 7 inclusion and 13 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: stopped early, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: The study was terminated early by the Sponsor for reasons unrelated to patient safety or anti-tumor activity.). Results are not available in the source record.
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?
Incidence and nature of dose-limiting toxicities (time frame: Through study completion or early study discontinuation). 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 NCT00977067, which also lists 1 linked publication.
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 21 Jun 2017.