Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00842335 · ClinicalTrials.gov registry record · Phase 1

A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumors, sponsored by Jubilant Innovation.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT00842335: Completed Phase 1 study of Advanced Solid Tumors, sponsored by Jubilant Innovation.

NCT00842335 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Jubilant Innovation. The registered enrollment target is 18 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00842335, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Jubilant Innovation.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study, the first clinical trial of JI-101, is to determine the maximum tolerated dose of JI-101 when given orally to patients with solid tumors. Safety, tolerability, pharmacokinetics, pharmacodynamics, and the effects of the drug on tumor metabolism will also be studied. JI-101 is an inhibitor of new blood vessel growth that may provide benefit to patients with solid tumors that have failed standard therapeutic regimens.

Primary Outcome

The primary objective of this study was to determine the maximum tolerated dose (MTD) of JI-101 when administered orally in patients with advanced solid tumors. The MTD was established based on safety data from Cycle 1. Patients who completed 21 days of treatment in Cycle 1 were considered to have completed the study for the determination of MTD. Patients were eligible to continue treatment with JI-101 until they experienced disease progression or unacceptable treatment-related toxicity. Unacc

Conditions Studied

Interventions

  • DRUG JI-101

Study Locations (1)

Arizona

  • Premiere Oncology of Arizona - Scottsdale

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2009-02
Est. Completion 2012-01
Phase Phase 1
Jubilant Innovation

1 total trials

What the finished NCT00842335 record still lists

NCT00842335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which JI-101 is the first listed.

NCT00842335 reports a single indexed study location in Arizona.

Frequently Asked Questions

What is clinical trial NCT00842335 about?

NCT00842335 is a clinical study titled "A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors". The purpose of this study, the first clinical trial of JI-101, is to determine the maximum tolerated dose of JI-101 when given orally to patients with solid tumors. Safety, tolerability, pharmacokinetics, pharmacodynamics, and the effects of the drug on tumor metabolism will also be studied. JI-101 ...

What is the current status of trial NCT00842335?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2009-02. Estimated completion is 2012-01.

What conditions does trial NCT00842335 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT00842335?

The interventions under investigation include: JI-101 (DRUG).

Who is sponsoring clinical trial NCT00842335?

This trial is sponsored by Jubilant Innovation, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00842335 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Advanced Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00842335's enrollment target sits among peer trials

18 128th of 144 higher than 15 of 144 other Advanced Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01245179 · 18 participants · Phase 1

    Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease

  • NCT01999361 · 18 participants · NA

    Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

  • NCT02359825 · 18 participants · Phase 1

    Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

  • NCT02870244 · 18 participants · Phase 1

    Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00842335, the US trial registry maintained by the National Library of Medicine. NCT00842335 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.