Germ Cell TumorPhase 1NCT02429466
Study of the Hypomethylating Drug Guadecitabine (SGI-110) Plus Cisplatin in Relapsed Refractory Germ Cell Tumors
A Phase 1 study testing Guadecitabine (SGI-110) in people with Germ Cell Tumor and Testis Cancer, run by Nasser Hanna at 2 sites in United States.
Trial summary
This is an open-label, single arm, Phase I dose escalation study in subjects with refractory germ cell tumor (rGCT). This phase I will evaluate the safety and efficacy of SGI-110 in combination with cisplatin in subjects with rGCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Germ Cell Tumor, Testis Cancer, Testicular Cancer
- What is being tested?
- Guadecitabine (SGI-110)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Apr 2015to 13 Feb 2019
- 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
- ≥ 18 years old at the time of informed consent
- Written informed consent and HIPAA authorization for release of personal health information.
- Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy for tumor cells before therapy at Cycle 1, Day 1, and Day 8 (before cisplatin dose) if this is clinically and safely feasible to do so.
- Subjects with histologically or serologically confirmed diagnosis of recurrent germ cell tumor.
- Subjects who have platinum-resistant disease. There is no limit on the number of prior treatment regimens.
- Subjects must have had prior high dose chemotherapy (HDCT) treatment when indicated.
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- Subjects who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or elevated Tumor markers (hCG or AFP).
- Note: patients without measurable disease are allowed on the study as long as they have clearly rising tumor markers and they will be exempt from biopsy.
- Subjects with ECOG performance status of 0-2.
- Subjects must be at least 3 weeks from last chemotherapy.
- Females of childbearing potential must not be pregnant or breast-feeding. Male and female patients of reproductive potential must agree to use two forms of highly effective contraception from the screening visit through 30 days after the last dose of study drug. Acceptable forms of effective contraception include:
- Oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.] Pregnancy tests for females of childbearing potential are required; must be serum at screening and the post treatment safety assessment visit. A positive urine pregnancy test must be confirmed by a serum pregnancy test and a pelvic US since some NSGCT may secrete beta-hCG and cause a false positive pregnancy. A pelvic US does not need to be repeated with each cycle unless the treating physician thinks it is necessary to do so.
- The following laboratory values must be obtained within 14 days prior to registration for protocol therapy.
- Absolute neutrophil count ≥ 1500 cells/mm3
- Hemoglobin (Hgb) ≥ 8 g/dL
- Platelets count ≥ 100,000 cells/mm3
- Serum creatinine levels ≤ 1.5 mg/dl and calculated (by Cockcroft-Gault formula) or measured creatinine clearance ≥ 50 mL/min
- Bilirubin ≤ 2 x ULN
- Aspartate aminotransferase (AST, SGOT) ≤ 3 x ULN
- Alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN
Who cannot join
- Active central nervous system (CNS) metastases. Subjects with neurological symptoms should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion of the treating physician.
- NOTE: A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
- Treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- Concurrent participation in a clinical trial which involves another investigational agent.
- Subjects with Grade 2 or greater neuropathy.
- Subjects with a life-threatening illness, medical condition or organ system dysfunction, or other reasons which, in the Investigator's opinion, could compromise the subject's safety, interfere with or compromise the integrity of the study outcomes including incomplete recovery from the acute effects from any prior anti-neoplastic therapy.
- Pregnancy or breast-feeding.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Hospital
Indianapolis, Indiana, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Phase I Study of the Hypomethylating Drug SGI-110 Plus Cisplatin in Relapsed Refractory Germ Cell Tumors
This is an open-label, single arm, Phase I dose escalation study in subjects with refractory germ cell tumor (rGCT). This phase I will evaluate the safety and efficacy of SGI-110 in combination with cisplatin in subjects with rGCT. The primary objective is to determine the maximum tolerated dose (MTD) of SGI-110 to be used prior to cisplatin. A total of 15 subjects will be enrolled in this study at the Indiana University Simon Cancer Center.
Read the detailed description
Primary Objective:
To assess the safety and toxicity of guadecitabine (SGI-110) plus cisplatin including the dose limiting toxicity (DLT) and to determine the Maximum tolerated dose (MTD)
Secondary Objective:
To assess the efficacy of guadecitabine (SGI-110) to resume sensitivity to cisplatin in refractory GCT
Correlative Objective:
To evaluate the pharmacodynamic activity of guadecitabine (SGI-110) Evaluate miRNA biomarkers in serum on day 1 of cycles 1-6
Intervention and Mode of Delivery: Guadecitabine (SGI-110) will be given subcutaneously, daily, 30 mg/m2 on days (1-5) followed by cisplatin 100mg/m2 on day 8 every 4 weeks.
Duration of Intervention and Evaluation:
Treatment will be continued for a maximum of 6 cycles or until disease progression or unacceptable toxicity whichever occurs first. Subjects who are responding to therapy without major toxicty would be allowed to continue on single agent guadecitabine (SGI-110) at the MTD after 4-6 cycles of the combination therapy until disease progression. Subjects will be followed after the last cycle every 2 months for the 1st year, and every 4 months thereafter until death (expected overall survival less than 12 months).
- Conditions
- Germ Cell Tumor, Testis Cancer, Testicular Cancer
- Being tested
- Guadecitabine (SGI-110)
- Keywords
- testicular germ cell tumor, ovarian germ cell tumor, platinum refractory, cisplatin, SGI110, Guadecitabine
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Testicular Neoplasms, Testicular Germ Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guadecitabine (SGI-110)Drug
Also called Guadecitabine
SGI-110 will be given subcutaneously, daily, 30 mg/m2 on days (1-5) followed by cisplatin 100mg/m2 on day 8 every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Guadecitabine (SGI-110) | Experimental | Not described Receives: Drug: Guadecitabine (SGI-110) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) of guadecitabine (SGI-110) plus cisplatin
Measured: During chemotherapy (weeks 1-18)
Maximum tolerated dose (MTD) of SGI-110 plus cisplatin
Measured: During chemotherapy (weeks 1-18)
Secondary outcomes (2)
Objective response rate (ORR)
To evaluate Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Days 42, 84, 126, 159, and 220
Progression free survival (PFS)
The investigators will look at the duration between starting the therapy until progression of disease of subjects on this study
Measured: Days 42, 84, 126, 159, and 220
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start27 Apr 2015
- Primary completion4 Jun 2018
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasser Hanna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nasser Hanna, Indiana University
- Investigators
- Nasser Hanna, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429466
- Sponsor's protocol ID
- IUCRO-0508
- Other IDs
- 1502729080
- Status last verified
- Sep 2020
- First submitted
- 14 Apr 2015
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Hypomethylating Drug SGI-110 Plus Cisplatin in Relapsed Refractory Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT02429466
- Acronym / sponsor ID
- IUCRO-0508
- Conditions
- Germ Cell Tumor, Testis Cancer, Testicular Cancer
- Keywords
- testicular germ cell tumor, ovarian germ cell tumor, platinum refractory, cisplatin, SGI110, Guadecitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nasser HannaUniversity, hospital or other
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 29 Apr 2015 (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.
This is an open-label, single arm, Phase I dose escalation study in subjects with refractory germ cell tumor (rGCT). This phase I will evaluate the safety and efficacy of SGI-110 in combination with cisplatin in subjects with rGCT. The primary objective is to determine the maximum tolerated dose (MTD) of SGI-110 to be used prior to cisplatin. A total of 15 subjects will be enrolled in this study at the Indiana University Simon Cancer Center.
Detailed description
Primary Objective:
To assess the safety and toxicity of guadecitabine (SGI-110) plus cisplatin including the dose limiting toxicity (DLT) and to determine the Maximum tolerated dose (MTD)
Secondary Objective:
To assess the efficacy of guadecitabine (SGI-110) to resume sensitivity to cisplatin in refractory GCT
Correlative Objective:
To evaluate the pharmacodynamic activity of guadecitabine (SGI-110) Evaluate miRNA biomarkers in serum on day 1 of cycles 1-6
Intervention and Mode of Delivery: Guadecitabine (SGI-110) will be given subcutaneously, daily, 30 mg/m2 on days (1-5) followed by cisplatin 100mg/m2 on day 8 every 4 weeks.
Duration of Intervention and Evaluation:
Treatment will be continued for a maximum of 6 cycles or until disease progression or unacceptable toxicity whichever occurs first. Subjects who are responding to therapy without major toxicty would be allowed to continue on single agent guadecitabine (SGI-110) at the MTD after 4-6 cycles of the combination therapy until disease progression. Subjects will be followed after the last cycle every 2 months for the 1st year, and every 4 months thereafter until death (expected overall survival less than 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guadecitabine (SGI-110) | Experimental | Drug: Guadecitabine (SGI-110) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- ≥ 18 years old at the time of informed consent
- Written informed consent and HIPAA authorization for release of personal health information.
- Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy for tumor cells before therapy at Cycle 1, Day 1, and Day 8 (before cisplatin dose) if this is clinically and safely feasible to do so.
- Subjects with histologically or serologically confirmed diagnosis of recurrent germ cell tumor.
- Subjects who have platinum-resistant disease. There is no limit on the number of prior treatment regimens.
Key exclusion criteria (7 listed)
- Active central nervous system (CNS) metastases. Subjects with neurological symptoms should undergo a head CT scan or brain MRI to exclude brain metastasis, at the discretion of the treating physician.
- NOTE: A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
- Treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- Concurrent participation in a clinical trial which involves another investigational agent.
- Subjects with Grade 2 or greater neuropathy.
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 |
|---|---|---|
| Guadecitabine (SGI-110)Also: GuadecitabineSGI-110 will be given subcutaneously, daily, 30 mg/m2 on days (1-5) followed by cisplatin 100mg/m2 on day 8 every 4 weeks. | Drug | Guadecitabine (SGI-110) |
Primary outcome
Dose limiting toxicity (DLT) of guadecitabine (SGI-110) plus cisplatin
Time frame: During chemotherapy (weeks 1-18)
Maximum tolerated dose (MTD) of SGI-110 plus cisplatin
Time frame: During chemotherapy (weeks 1-18)
2 secondary outcomes
Objective response rate (ORR)
Time frame: Days 42, 84, 126, 159, and 220
Progression free survival (PFS)
Time frame: Days 42, 84, 126, 159, and 220
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
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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.
Nasser Hanna, MD principal investigator
Indiana University
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 Guadecitabine (SGI-110) in people with Germ Cell Tumor and Testis Cancer, run by Nasser Hanna 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 24 inclusion and 7 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 Sep 2020. 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?
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?
Dose limiting toxicity (DLT) of guadecitabine (SGI-110) plus cisplatin (time frame: During chemotherapy (weeks 1-18)). 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 23 Sep 2020.