CancerPhase 1NCT01604863
A Study of HGS1036 in Combination With Chemotherapy in Subjects With Advanced Solid Malignancies
A Phase 1 study testing HGS1036 + Paclitaxel + Carboplatin, HGS1036 + Cisplatin + Etoposide and HGS1036 + Docetaxel in people with Cancer, run by Human Genome Sciences Inc., a GSK Company at 2 sites in United States.
Trial summary
The primary purpose of this study is to determine the maximally tolerated dose (MTD) of HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, or docetaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- HGS1036 + Paclitaxel + Carboplatin, HGS1036 + Cisplatin + Etoposide and HGS1036 + Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Jul 2014
- 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
- Have a histological or cytological diagnosis of malignant solid neoplasm requiring systemic chemotherapy.
- Age ≥18 years.
- ECOG performance status 0-1.
- Adequate organ function.
- Adequate hematological function.
- Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study protocol procedures.
- Consent to collection of previously obtained, archival biopsy or surgical specimens of the currently treated malignancy when available.
Who cannot join
- Significant cardiac disease.
- Eye trauma or disease.
- Ocular surgery or blunt force trauma to the eye requiring treatment within 3 months prior to first dose of HGS1036.
- Presence or history of ≥ Grade 2 hemoptysis within 2 weeks of the first dose of HGS1036.
- Major surgery within 4 weeks of the first dose of HGS1036.
- Prior organ or allogeneic stem cell transplant.
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- Non-healing or chronic wounds.
- Receipt of any anti-cancer therapy within 4 weeks prior to first dose of HGS1036.
- Receipt of any biological therapy (such as monoclonal antibodies) within 6 weeks of the first dose of HGS1036.
- Active CNS involvement by primary or metastatic tumor.
- Documented active infection requiring the use of systemic antibiotics.
- Pregnancy or lactation.
- Known HIV-positive serology, AIDS, or an AIDS-related illness.
- Conditions likely to increase the potential for abdominal perforation or fistula formation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Boston, Massachusetts, 02114
Study site
Scottsdale, Arizona, 85258
About this study
Official title: Multi-Center, Open-Label Phase 1B Study to Evaluate the Safety and Tolerability of HGS1036 in Combination With Paclitaxel and Carboplatin, Cisplatin and Etoposide, or Docetaxel in Subjects With Advanced Solid Malignancies
The primary purpose of this study is to determine the maximally tolerated dose (MTD) of HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, or docetaxel.
Read the detailed description
This study will consist of 3 regimens each containing 2 dose levels of HGS1036 and full dose chemotherapy. Patients will be treated in sequence with HGS1036 at planned dose levels of 10 mg/kg and 20 mg/kg. Patients who demonstrate stable disease or better may continue to receive HGS1036 until progressive disease, unacceptable toxicity, patient requests discontinuation of study treatment, or the Investigator feels further treatment is not in the patient's best interest. After discontinuation of HGS1036, subjects will be followed for 30 days after the last dose of HGS1036 for safety. The end of study will be defined as 1 year after the last subject begins treatment of HGS1036. Any subject still receiving HGS1036 at this pre-defined end of study, may continue to receive HGS1036, but the only study assessments required will be for safety.
- Conditions
- Cancer
- Being tested
- HGS1036 + Paclitaxel + Carboplatin, HGS1036 + Cisplatin + Etoposide, HGS1036 + Docetaxel
- Keywords
- Solid Tumors, Cancer, Lung Cancer, Prostate Cancer, Mesothelioma, Small Cell lung Cancer
- Medical subject headings
- Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Mesothelioma, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGS1036 + Paclitaxel + CarboplatinDrug
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle. Paclitaxel 175 mg/m2 or 200 mg/m2, IV and carboplatin AUC 6.0 mg∙min/mL, IV every 3 weeks on Day 1 of each 21-day cycle.
HGS1036 + Cisplatin + EtoposideDrug
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and cisplatin 60-80 mg/m2, IV on Day 1 and etoposide 100-120 mg/m2, IV on Days 1, 2, and 3 of each 21 day cycle.
HGS1036 + DocetaxelDrug
HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and docetaxel 75 mg/m2, IV on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | HGS1036 + Paclitaxel + Carboplatin Receives: Drug: HGS1036 + Paclitaxel + Carboplatin |
| Arm B | Experimental | HGS1036 + Cisplatin + Etoposide Receives: Drug: HGS1036 + Cisplatin + Etoposide |
| Arm C | Experimental | HGS1036 + Docetaxel Receives: Drug: HGS1036 + Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: Up to 1 year or longer if indicated.
Number of participants with adverse events
Measured: Up to 1 year or longer if indicated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Why it stopped: Study suspended prior to enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Human Genome Sciences Inc., a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604863
- Sponsor's protocol ID
- HGS1036-C1118
- Status last verified
- Oct 2012
- First submitted
- 23 Jan 2012
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Open-Label Phase 1B Study to Evaluate the Safety and Tolerability of HGS1036 in Combination With Paclitaxel and Carboplatin, Cisplatin and Etoposide, or Docetaxel in Subjects With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01604863
- Acronym / sponsor ID
- HGS1036-C1118
- Conditions
- Cancer
- Keywords
- Solid Tumors, Cancer, Lung Cancer, Prostate Cancer, Mesothelioma, Small Cell lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study suspended prior to enrollment
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Human Genome Sciences Inc., a GSK CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 24 May 2012 (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 primary purpose of this study is to determine the maximally tolerated dose (MTD) of HGS1036 when used in combination with the standard chemotherapeutic regimens paclitaxel plus carboplatin, cisplatin plus etoposide, or docetaxel.
Detailed description
This study will consist of 3 regimens each containing 2 dose levels of HGS1036 and full dose chemotherapy. Patients will be treated in sequence with HGS1036 at planned dose levels of 10 mg/kg and 20 mg/kg. Patients who demonstrate stable disease or better may continue to receive HGS1036 until progressive disease, unacceptable toxicity, patient requests discontinuation of study treatment, or the Investigator feels further treatment is not in the patient's best interest. After discontinuation of HGS1036, subjects will be followed for 30 days after the last dose of HGS1036 for safety. The end of study will be defined as 1 year after the last subject begins treatment of HGS1036. Any subject still receiving HGS1036 at this pre-defined end of study, may continue to receive HGS1036, but the only study assessments required will be for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: HGS1036 + Paclitaxel + CarboplatinHGS1036 + Paclitaxel + Carboplatin |
| Arm B | Experimental | Drug: HGS1036 + Cisplatin + EtoposideHGS1036 + Cisplatin + Etoposide |
| Arm C | Experimental | Drug: HGS1036 + DocetaxelHGS1036 + Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a histological or cytological diagnosis of malignant solid neoplasm requiring systemic chemotherapy.
- Age ≥18 years.
- ECOG performance status 0-1.
- Adequate organ function.
- Adequate hematological function.
Key exclusion criteria (14 listed)
- Significant cardiac disease.
- Eye trauma or disease.
- Ocular surgery or blunt force trauma to the eye requiring treatment within 3 months prior to first dose of HGS1036.
- Presence or history of ≥ Grade 2 hemoptysis within 2 weeks of the first dose of HGS1036.
- Major surgery within 4 weeks of the first dose of HGS1036.
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 |
|---|---|---|
| HGS1036 + Paclitaxel + CarboplatinHGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle. Paclitaxel 175 mg/m2 or 200 mg/m2, IV and carboplatin AUC 6.0 mg∙min/mL, IV every 3 weeks on Day 1 of each 21-day cycle. | Drug | Arm A |
| HGS1036 + Cisplatin + EtoposideHGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and cisplatin 60-80 mg/m2, IV on Day 1 and etoposide 100-120 mg/m2, IV on Days 1, 2, and 3 of each 21 day cycle. | Drug | Arm B |
| HGS1036 + DocetaxelHGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and docetaxel 75 mg/m2, IV on Day 1 of each 21-day cycle. | Drug | Arm C |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Up to 1 year or longer if indicated.
Number of participants with adverse events
Time frame: Up to 1 year or longer if indicated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HGS1036 + Paclitaxel + Carboplatin, HGS1036 + Cisplatin + Etoposide and HGS1036 + Docetaxel in people with Cancer, run by Human Genome Sciences Inc., a GSK Company at 2 sites 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 7 inclusion and 14 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: paused, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Maximum Tolerated Dose (MTD) (time frame: Up to 1 year or longer if indicated.). 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?
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 1 Nov 2012.