CompletedPhase 1/2

A Phase 1/2 Trial SRA737 in Combination With Gemcitabine and Cisplatin or Gemcitabine Alone in Advanced Cancer Subjects

Spain153 participantsStarted 2016-07

Plain-language summary

The purpose of this clinical study is to establish the safety profile, determine the maximum tolerated dose (MTD) and recommend a Phase 2 dose (RP2D) and schedule of SRA737 in combination with low dose gemcitabine; and to evaluate the efficacy of SRA737 in combination with low dose gemcitabine in prospectively-selected subjects with genetically-defined tumors that have predicted sensitivity to Chk1 inhibition based on factors including: genetic profiling of tumor tissue or ctDNA, HPV status, and germline BRCA1 and BRCA2 gene status. Specific cancer indications that frequently feature these factors will be studied. Preclinical and clinical data support the hypothesis that active doses of SRA737 may be strongly potentiated by sub-therapeutic doses of gemcitabine, which should lead to clinical efficacy. To test this hypothesis, SRA737 in combination with low dose gemcitabine is being explored in this study.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. For Dose Escalation: subjects with locally advanced or metastatic, histologically or cytologically proven solid tumor, relapsed after or progressing despite conventional treatment
✓. Life expectancy of at least 12 weeks
✓. World Health Organization (WHO) performance status of 0-1
✓. Must meet select hematological and biochemical laboratory indices
✓. Archival tumor tissue or accessible tumor and willingness to consent to a biopsy
✓. Histologically or cytologically proven advanced malignancy of the following types, for which no other conventional therapy is considered appropriate:
✓. Measurable disease per RECIST v1.1
✓. Subjects must have predicted sensitivity to Chk1 inhibition based on factors including: genetic profiling of tumor tissue or ctDNA, HPV status, and germline BRCA1 and BRCA2 gene status. All subjects will have genetic profiling from tumor tissue or ctDNA; profiling will be performed prospectively if required to evaluate Chk1 sensitivity or otherwise performed retrospectively.

Exclusion criteria

What they're measuring

Number of subjects with adverse events as assessed by CTCAE4.03

Timeframe: Up to 30 days after last dose of SRA737

Maximum tolerated dose of SRA737 administered in combination with gemcitabine

Timeframe: Cycle 1 (28 days) in the Dose Escalation Phase

Recommended Phase 2 dose of SRA737 in combination with gemcitabine.

Timeframe: Up to 30 days after last dose of SRA737

Trial details

NCT IDNCT02797977

SponsorSierra Oncology LLC - a GSK company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-08

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. For Dose Escalation: subjects with locally advanced or metastatic, histologically or cytologically proven solid tumor, relapsed after or progressing despite conventional treatment
✓. Life expectancy of at least 12 weeks
✓. World Health Organization (WHO) performance status of 0-1
✓. Must meet select hematological and biochemical laboratory indices
✓. Archival tumor tissue or accessible tumor and willingness to consent to a biopsy
✓. Histologically or cytologically proven advanced malignancy of the following types, for which no other conventional therapy is considered appropriate:
✓. Measurable disease per RECIST v1.1
✓. Subjects must have predicted sensitivity to Chk1 inhibition based on factors including: genetic profiling of tumor tissue or ctDNA, HPV status, and germline BRCA1 and BRCA2 gene status. All subjects will have genetic profiling from tumor tissue or ctDNA; profiling will be performed prospectively if required to evaluate Chk1 sensitivity or otherwise performed retrospectively.

Exclusion criteria

What they're measuring

Number of subjects with adverse events as assessed by CTCAE4.03

Timeframe: Up to 30 days after last dose of SRA737

Maximum tolerated dose of SRA737 administered in combination with gemcitabine

Timeframe: Cycle 1 (28 days) in the Dose Escalation Phase

Recommended Phase 2 dose of SRA737 in combination with gemcitabine.

Timeframe: Up to 30 days after last dose of SRA737