Malignant Advanced Solid TumorPhase 1NCT02993913
Safety, Tolerability and Pharmacokinetics of Simmiparib in Patients With Malignant Advanced Solid Tumor
A Phase 1 study testing Simmiparib in people with Malignant Advanced Solid Tumor, run by Shanghai Acebright Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
Phase I dose escalating trial. Primary objectives of this study are to assess the safety and tolerability of Simmiparib following single and multiple oral doses in patients with advanced solid malignancies, to determine the maximum tolerance dose (MTD) and dose limiting toxicity (DLT), and pharmacokinetic profile. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Advanced Solid Tumor
- What is being tested?
- Simmiparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients confirmed with advanced solid tumor based on pathology and/or cytology, considered unresponsive or poorly responsive to standard therapies, no curative therapies or can't tolerate standard therapies;
- Patients must have measurable disease in accordance with RECIST criteria v. 1.1, at least one lesion that can be accurately measured in CT and MRI at least one dimension ( longest diameter≥10mm; if lymph node, short diameter≥15mm );
- Age≥18 and ≤75 years, both men and women, no history of drug abuse and alcohol;
- Life expectancy≥ 3 months and can be followed for safety and efficiency
- Received no prior anti-tumor therapies at least within past 4 weeks and no other adjuvant anti-tumor regimen(including steroids mediations )
- Have recovered to≤ common terminology criteria of adverse events (CTC-AE) 1 from toxicities of prior therapy
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- Not participated in any clinical trials within 28 days;
- Not have received treatment of poly-ADP ribose polymerase (PARP) inhibitor;
- No serious abnormal hematopoiesis function, has adequate cardiac, pulmonic, hepatic and renal function. Blood routine and blood biochemical examination within 2 weeks before enrollment : White blood cell (WBC) ≥4000/mm3, Absolute neutrophil count (ANC) ≥1,500/mm3, Platelets ≥100,000/mm3, Coagulation function ≤ 1.5 times upper limit of normal (ULN), serum creatinine ≤ 1.5 times ULN, Total bilirubin ≤ 1.5 times ULN, Patients without liver metastasis, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)≤ 2.5 times ULN; Patients with liver metastasis, Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/≤ 2.5 times ULN, NYHAclass≤Ⅱand Left ventricular ejection fraction ( LVEF)>50%;
- Virology test: negative HbsAg, HCV, HIV and syphilis
- Eastern Cooperative Oncology Group(ECOG) performance status ≤2;
- No history of other malignant tumors, except cervical carcinoma in situ, basal skin cancer or squamous-cell carcinoma that have been cured; No other serious illnesses that are in conflict with this study and significant heart disease and psychosis;
- Ability to understand and a willingness to sign a written informed consent; Obtaining consent before any operation
Who cannot join
- Patients with serious medical disease, including, severe cardiopathy, vascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection , or psychosis, etc.;
- Patients with primary brain lesion or metastases lesion;
- Female patient who is pregnant, breast feeding or unwilling to contraception;
- Patient who received or is receiving any other investigational agents within 4 weeks prior to treatment;
- Patients, with poor compliance, or based on the opinion of the investigator, should not be enrolled into this study;
- has not recovered to grade 1 or better from any adverse events related to previous therapy.
- Neurotoxicity observed in previous antineoplastic therapy has not recovered to grade 1 or below.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xichun Hu, Ph.D.
About this study
Official title: A Safety, Tolerability and Pharmacokinetic Study of Single and Repeat Oral Escalating Doses of Simmiparib in Patients With Advanced Malignant Tumors
Phase I dose escalating trial. Primary objectives of this study are to assess the safety and tolerability of Simmiparib following single and multiple oral doses in patients with advanced solid malignancies, to determine the maximum tolerance dose (MTD) and dose limiting toxicity (DLT), and pharmacokinetic profile.
The Secondary objective is to observe the preliminary antitumor effect of Simmiparib.
Read the detailed description
This single-center, nonrandomized, open-label, dose-escalating study. The trial was divided into dose escalation and expansion stages.
- Conditions
- Malignant Advanced Solid Tumor
- Being tested
- Simmiparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimmiparibDrug
Also called SMOCL-9112
Simmiparib Tablets, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Simmiparib tablet monotherapy | Experimental | Drug: Simmiparib tablet oral Qd or Bid Receives: Drug: Simmiparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The Dose level at which more than 1/6 patients develop a Dose Limiting Toxicity (DLT)
Measured: Per doselevel of 3 to 6 patients (When 3-6 patients have completed DLT periods of 4 weeks)
Pharmacokinetic Cmax (maximum concentration)
PK blood collection Before 0:00h and after 0.25h、0.50h、1:00h、1.50h、2:00h、3:00h、4:00h、6:00h、8:00h、10:00h、24:00h、48:00h、72:00h at single dose period.
PK blood collection before 0:00h and after 0.25h、0.50、1:00h、1.50h、2:00h、3:00h、4:00h、6:00h、8:00h、10:00h and 12:00h at multiple dose period
Measured: At day 1 single dose period, day 8 and 28 multiple dose period day
Pharmacokinetic Tmax (Time of maximum concentration)
Measured: At day 1 single dose period, day 8 and 28 multiple dose period day
Pharmacokinetics AUC (Area Under the Curve)
Measured: At day 1 single dose period, day 8 and 28 multiple dose period day
Secondary outcomes (2)
Poly ADP-ribose polymerase (PARP) inhibition measured by PAR assay
Measured: Up to 4 months
Overall Response Rate (ORR)
ORR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Advanced Solid 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Acebright Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993913
- Sponsor's protocol ID
- ACE-CT-006I
- Status last verified
- Dec 2016
- First submitted
- 6 Dec 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability and Pharmacokinetic Study of Single and Repeat Oral Escalating Doses of Simmiparib in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT02993913
- Acronym / sponsor ID
- ACE-CT-006I
- Conditions
- Malignant Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Acebright Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- First posted
- 15 Dec 2016 (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.
Phase I dose escalating trial. Primary objectives of this study are to assess the safety and tolerability of Simmiparib following single and multiple oral doses in patients with advanced solid malignancies, to determine the maximum tolerance dose (MTD) and dose limiting toxicity (DLT), and pharmacokinetic profile.
The Secondary objective is to observe the preliminary antitumor effect of Simmiparib.
Detailed description
This single-center, nonrandomized, open-label, dose-escalating study. The trial was divided into dose escalation and expansion stages.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simmiparib tablet monotherapy | Experimental | Drug: SimmiparibDrug: Simmiparib tablet oral Qd or Bid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients confirmed with advanced solid tumor based on pathology and/or cytology, considered unresponsive or poorly responsive to standard therapies, no curative therapies or can't tolerate standard therapies;
- Patients must have measurable disease in accordance with RECIST criteria v. 1.1, at least one lesion that can be accurately measured in CT and MRI at least one dimension ( longest diameter≥10mm; if lymph node, short diameter≥15mm );
- Age≥18 and ≤75 years, both men and women, no history of drug abuse and alcohol;
- Life expectancy≥ 3 months and can be followed for safety and efficiency
- Received no prior anti-tumor therapies at least within past 4 weeks and no other adjuvant anti-tumor regimen(including steroids mediations )
Key exclusion criteria (7 listed)
- Patients with serious medical disease, including, severe cardiopathy, vascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection , or psychosis, etc.;
- Patients with primary brain lesion or metastases lesion;
- Female patient who is pregnant, breast feeding or unwilling to contraception;
- Patient who received or is receiving any other investigational agents within 4 weeks prior to treatment;
- Patients, with poor compliance, or based on the opinion of the investigator, should not be enrolled into this study;
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 |
|---|---|---|
| SimmiparibAlso: SMOCL-9112Simmiparib Tablets, oral administration | Drug | Simmiparib tablet monotherapy |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Per doselevel of 3 to 6 patients (When 3-6 patients have completed DLT periods of 4 weeks)
The Dose level at which more than 1/6 patients develop a Dose Limiting Toxicity (DLT)
Pharmacokinetic Cmax (maximum concentration)
Time frame: At day 1 single dose period, day 8 and 28 multiple dose period day
PK blood collection Before 0:00h and after 0.25h、0.50h、1:00h、1.50h、2:00h、3:00h、4:00h、6:00h、8:00h、10:00h、24:00h、48:00h、72:00h at single dose period. PK blood collection before 0:00h and after 0.25h、0.50、1:00h、1.50h、2:00h、3:00h、4:00h、6:00h、8:00h、10:00h and 12:00h at multiple dose period
Pharmacokinetic Tmax (Time of maximum concentration)
Time frame: At day 1 single dose period, day 8 and 28 multiple dose period day
Pharmacokinetics AUC (Area Under the Curve)
Time frame: At day 1 single dose period, day 8 and 28 multiple dose period day
2 secondary outcomes
Poly ADP-ribose polymerase (PARP) inhibition measured by PAR assay
Time frame: Up to 4 months
Overall Response Rate (ORR)
Time frame: Up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
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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.
Xichun Hu principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Simmiparib in people with Malignant Advanced Solid Tumor, run by Shanghai Acebright Pharmaceuticals Co., Ltd. at 1 site in China.
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 13 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: status not confirmed, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact MohammadAbdul Kaium (0086-21-51323300 ext. 4080, kaium@acebright.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: Per doselevel of 3 to 6 patients (When 3-6 patients have completed DLT periods of 4 weeks)). The study lists 4 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 5 Jan 2017.