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A Phase 1, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies

A Phase 1, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220802
Enrollment
45
Registered
2009-08-13
Start date
2009-08-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Solid Tumors, Advanced Solid Malignancies

Interventions

investigational material(s) Generic name etc : AZD7762, Gemcitabine (Gemzar) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inv

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective - Must be suitable for treatment with gemcitabine - Relatively good overall health other than cancer

Exclusion criteria

Exclusion criteria: - Poor bone marrow function (not producing enough blood cells) - Poor liver or kidney function - Serious heart conditions

Design outcomes

Primary

MeasureTime frame
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram—

Secondary

MeasureTime frame
- Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine - Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026