Safety, Tolerability and Pharmacokinetics of Simmiparib in Patients With Malignant Advanced Solid Tumor

NCT ID: NCT02993913

Last Updated: 2017-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31

Brief 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.

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.

Conditions

Malignant Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Simmiparib tablet monotherapy

Drug: Simmiparib tablet oral Qd or Bid

Group Type: EXPERIMENTAL

Simmiparib

Intervention Type: DRUG

Simmiparib Tablets, oral administration

Interventions

Simmiparib

Simmiparib Tablets, oral administration

Intervention Type: DRUG

Other Intervention Names

SMOCL-9112

Eligibility Criteria

Inclusion Criteria

1. 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;

2. 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 );

3. Age≥18 and ≤75 years, both men and women, no history of drug abuse and alcohol;

4. Life expectancy≥ 3 months and can be followed for safety and efficiency

5. Received no prior anti-tumor therapies at least within past 4 weeks and no other adjuvant anti-tumor regimen(including steroids mediations )

6. Have recovered to≤ common terminology criteria of adverse events (CTC-AE) 1 from toxicities of prior therapy

7. Not participated in any clinical trials within 28 days;

8. Not have received treatment of poly-ADP ribose polymerase (PARP) inhibitor;

9. 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%;

10. Virology test: negative HbsAg, HCV, HIV and syphilis

11. Eastern Cooperative Oncology Group(ECOG) performance status ≤2;

12. 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;

13. Ability to understand and a willingness to sign a written informed consent; Obtaining consent before any operation

Exclusion Criteria

1. Patients with serious medical disease, including, severe cardiopathy, vascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection , or psychosis, etc.;

2. Patients with primary brain lesion or metastases lesion;

3. Female patient who is pregnant, breast feeding or unwilling to contraception;

4. Patient who received or is receiving any other investigational agents within 4 weeks prior to treatment;

5. Patients, with poor compliance, or based on the opinion of the investigator, should not be enrolled into this study;

6. has not recovered to grade 1 or better from any adverse events related to previous therapy.

7. Neurotoxicity observed in previous antineoplastic therapy has not recovered to grade 1 or below.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Acebright Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xichun Hu

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

MohammadAbdul Kaium

Role: CONTACT

kaium@acebright.com

0086-21-51323300 ext. 4080

Jian Liu

Role: CONTACT

jian.liu@acebright.com

0086-21-51323300

Facility Contacts

Xichun Hu, Ph.D.

Role: primary

Other Identifiers

ACE-CT-006I

Identifier Type: -

Identifier Source: org_study_id