Hepatocellular CarcinomaNCT02082691
Continued Administration of G-202 for One Patient With Advanced Hepatocellular Carcinoma
A study testing G-202 in people with Hepatocellular Carcinoma, run by Devalingam Mahalingam.
Trial summary
Patient with advanced liver cancer (cancer that has spread to other parts of the body) continues to receive the study drug (G-202) even though patient no longer meets the criteria to be a part of the main treatment study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- G-202
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- History of hepatocellular carcinoma
- Participation in prior research study where G-202 was administered
- Tolerance of G-202 treatment
- Demonstration of stable disease
Who cannot join
- Disease progression
- Occurrence of unacceptable toxicity
About this study
Official title: Single Patient IND: Continued Administration of G-202 to a Patient With Advanced Hepatocellular Carcinoma Previously Treated With G-202 and Receiving Clinical Benefit
Patient with advanced liver cancer (cancer that has spread to other parts of the body) continues to receive the study drug (G-202) even though patient no longer meets the criteria to be a part of the main treatment study. Patient's cancer responded well to receiving G-202 in the main study and will receive G-202 at the same dose given in the main study.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- G-202
- Keywords
- G-202, Hepatocellular
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-202Drug
Patient will receive G-202 for 3 days in a row, followed by 25 days without taking G-202. This cycle will be repeated every 28 days. Patient will receive G-202 as long as his/her cancer does not grow and the investigational drug side effects are tolerable.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Devalingam Mahalingam
- Sponsor type
- University, hospital or other
- Collaborators
- GenSpera, Inc.
- Responsible party
- Sponsor-investigator, Devalingam Mahalingam, The University of Texas Health Science Center at San Antonio
- Investigators
- Devalingam Mahalingam, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082691
- Sponsor's protocol ID
- CTRC 13-0040
- Other IDs
- HSC20130391T [UTHSCSA IRB]
- Status last verified
- Mar 2014
- First submitted
- 6 Mar 2014
- Last updated
- 10 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Patient IND: Continued Administration of G-202 to a Patient With Advanced Hepatocellular Carcinoma Previously Treated With G-202 and Receiving Clinical Benefit
- ClinicalTrials.gov ID
- NCT02082691
- Acronym / sponsor ID
- CTRC 13-0040
- Conditions
- Hepatocellular Carcinoma
- Keywords
- G-202, Hepatocellular
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Devalingam MahalingamUniversity, hospital or other
- Collaborators
- GenSpera, Inc.
- First posted
- 10 Mar 2014 (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.
Patient with advanced liver cancer (cancer that has spread to other parts of the body) continues to receive the study drug (G-202) even though patient no longer meets the criteria to be a part of the main treatment study. Patient's cancer responded well to receiving G-202 in the main study and will receive G-202 at the same dose given in the main study.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of hepatocellular carcinoma
- Participation in prior research study where G-202 was administered
- Tolerance of G-202 treatment
- Demonstration of stable disease
Key exclusion criteria (2 listed)
- Disease progression
- Occurrence of unacceptable toxicity
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 |
|---|---|---|
| G-202Patient will receive G-202 for 3 days in a row, followed by 25 days without taking G-202. This cycle will be repeated every 28 days. Patient will receive G-202 as long as his/her cancer does not grow and the investigational drug side effects are tolerable. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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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.
Devalingam Mahalingam, MD principal investigator
The University of Texas Health Science Center at San Antonio
Questions about this trial
What is this clinical trial studying?
A study testing G-202 in people with Hepatocellular Carcinoma, run by Devalingam Mahalingam.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Mar 2014. 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.
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.
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 10 Mar 2014.