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Advanced Adult Hepatocellular CarcinomaPhase 2G-202-003NCT01777594

Study of G-202 (Mipsagargin) as Second-Line Therapy Following Sorafenib in Hepatocellular Carcinoma

A Phase 2 study testing G-202 in people with Advanced Adult Hepatocellular Carcinoma, run by GenSpera, Inc. at 4 sites in United States.

Completed

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

Official record
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Trial summary

Hepatocellular carcinoma (HCC) is the fifth most common type of cancer worldwide and the third most common cause of death from cancer. Sorafenib is the only approved therapy for treatment of advanced HCC, and there is a need to identify more drugs that are beneficial for these patients without unacceptable side… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Adult Hepatocellular Carcinoma
What is being tested?
G-202
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
4 sitesUnited States
Study dates
Jan 2013to Mar 2015
Phase
Phase 2
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

  • Informed consent document signed prior to the performance of any study-specific procedures and initiation of study therapy
  • At least 18 years of age
  • ECOG Performance Status 0 or 1
  • Histologic or cytologic confirmation of hepatocellular carcinoma (HCC)
  • Child-Pugh score of A or B7
  • At least one measurable lesion (preferably in the liver) assessed within 4 weeks of first administration of G-202 by abdominal CT or MRI with dynamic phase imaging of the liver, pelvic CT or MRI with contrast, chest CT with contrast, and bone imaging in patients with known bone metastases or if medically indicated
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  • Must have received sorafenib therapy and had disease progression on sorafenib therapy or was not able to tolerate sorafenib
  • Sorafenib or other anti-cancer therapy must have been discontinued > 21days prior to the first administration of G-202
  • Adequate hematologic function (ANC ≥ 1200/mm3, hemoglobin ≥ 8.5 g/dL, platelet count ≥ 75,000/mm3)
  • Adequate hepatic function (albumin ≥ 2.8 g/dL, AST and ALT ≤ 5 x ULN, total bilirubin < 2 mg/dL)
  • Adequate renal function (proteinuria level ≤ 2+, serum creatinine ≤ 1.5 x ULN)
  • Acceptable coagulation profile (PT/INR ≤ 2.3, aPTT ≤ 1.5 x ULN)
  • Acute toxicity from previous therapy (excluding alopecia) must have resolved to ≤ Grade 1 per CTCAE v4.0
  • Negative serum pregnancy test for women of child-bearing potential

Who cannot join

  • Prior locoregional therapies (e.g., transarterial chemoembolization [TACE]) ≤ 4 weeks prior to the first administration of G-202 or not recovered from treatment-related toxicities.
  • Radiotherapy ≤ 4 weeks prior to the first administration of G-202 or not recovered from toxicities (palliative radiotherapy for bone lesions ≤ 2 weeks prior allowed)
  • Major surgery ≤ 4 weeks prior to first administration of G-202
  • Intolerance to both CT and MRI contrast agents
  • Candidate for liver transplantation
  • Persistent or untreated biliary infection
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  • Any GI bleeding within 12 weeks prior to first administration of G-202
  • Currently receiving any full-dose anti-coagulation treatment
  • Clinically-significant third space fluid accumulation
  • Known CNS metastasis, including brain metastasis or leptomeningeal metastasis
  • Known human immunodeficiency virus (HIV) positivity
  • Viral hepatitis requiring anti-viral therapy
  • History or evidence of cardiac risk, including screening QTc interval > 470 msec, clinically-significant uncontrolled arrhythmias or arrhythmia requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia), history of acute coronary syndromes within 6 months (including myocardial infarction and unstable angina, coronary artery bypass graft, angioplasty, or stenting) or history of congestive heart failure with most recent ejection fraction < 45%
  • Uncontrolled hypertension (systolic BP ≥ 160 or diastolic BP ≥ 100)
  • Cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose of study therapy
  • History of pulmonary embolism within 6 months or untreated deep venous thrombosis
  • Documentation of keratosis follicularis (also known as Darier or Darier-White disease)
  • Requirement for chronic use of inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes
  • Known hypersensitivity to any study drug component, including thapsigargin derivatives, polysorbate 20, or propylene glycol
  • Known history of another primary malignancy that has not been in remission for at least 2 years (non-melanoma skin cancer, cervical carcinoma in situ or squamous intraepithelial lesions allowed)
  • Use of any investigational agent within 4 weeks prior to the first administration of G-202
  • Pregnancy or nursing
  • Any medical intervention, other medical condition, psychiatric condition or social circumstance which could compromise patient safety and/or adherence with study requirements

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230

  • Oncology Consultants, PA

    Houston, Texas, 77030

  • University of Texas Health Sciences Center at Houston, Memorial Hermann Cancer Center

    Houston, Texas, 77030

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

Other trials in United States

About this study

Official title: A Phase II, Multicenter, Single-Arm Study of G-202 (Mipsagargin) as Second-Line Therapy Following Sorafenib for Adult Patients With Progressive Advanced Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most common type of cancer worldwide and the third most common cause of death from cancer. Sorafenib is the only approved therapy for treatment of advanced HCC, and there is a need to identify more drugs that are beneficial for these patients without unacceptable side effects. Prodrug chemotherapy is an approach in which an inactive non-toxic agent is administered to the patient and gets activated within the body at specific locations, resulting in a higher concentration of the cytotoxic form at a tumor location while avoiding general side effects. G-202 (mipsagargin) is an example of prodrug chemotherapy. It is activated by Prostate Specific Memory Antigen (PSMA), which is expressed by some cancer cells and in the blood vessels of most solid tumors, but not by normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the activity and safety of G-202 in patients with hepatocellular carcinoma who have progressed after taking sorafenib. The study will evaluate clinical activity and safety of G-202 administered by intravenous infusion on three consecutive days of a 28-day cycle.

Being tested
G-202
Keywords
hepatocellular carcinoma, HCC, liver, liver cancer, sorafenib
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

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

  • G-202Drug

    Also called Mipsagargin

    G-202 administered by intravenous infusion (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity

Study groups in NCT01777594
Study groupRoleWhat they receive
G-202 (Mipsagargin)ExperimentalG-202 (mipsagargin) administered by intravenous infusion on 3 consecutive days of a 28-day cycle
Receives: Drug: G-202

What is being measured

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

  1. Time to progression

    Duration of time from the first administration of G-202 to the time of radiologic progression

    Measured: every 8 weeks, until disease progression (estimated up to 2 years)

Secondary outcomes (3)

  1. Overall response rate

    Percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) after treatment with G-202

    Measured: every 8 weeks, until disease progression (estimated up to 2 years)

  2. Progression-free survival

    Duration of time from the first administration of G-202 to the time of radiologic progression or death

    Measured: every 8-12 weeks, until disease progression or death (estimated up to 3 years)

  3. Overall survival

    Duration of time from the first administration of G-202 to the time of death

    Measured: every 12 weeks for approximately 3 years or until patient death

Timeline

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

  1. First posted29 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01777594
Sponsor's protocol ID
G-202-003
Acronym
G-202-003
Status last verified
Aug 2016
First submitted
18 Jan 2013
Last updated
23 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing G-202 in people with Advanced Adult Hepatocellular Carcinoma, run by GenSpera, Inc. at 4 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 14 inclusion and 23 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 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to progression (time frame: every 8 weeks, until disease progression (estimated up to 2 years)). 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 NCT01777594.

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 23 Aug 2016.

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